Simtra BioPharma Solutions
Sterility Assurance Validation Media Team Associate I (2nd Shift)
Simtra BioPharma Solutions, Bloomington, Indiana, United States, 47401
Sterility Assurance Validation Media Team Associate I (2nd Shift)
Bloomington, Indiana, United States Simtra BioPharma Solutions (Simtra) is a world-class Contract Development Manufacturing Organization, partnering with pharmaceutical and biotech companies to bring their sterile injectable products to market. With facilities in Bloomington, Indiana, US and Halle/Westfalen, Germany, we offer a wide range of delivery systems including pre-filled syringes, liquid/lyophilized vials, diluents for reconstitution, powder-filled vials and sterile crystallization. Our product types include biologics and small molecules, cytotoxics, highly potent compounds, diluents for reconstitution and vaccines – which are all directly injected into patients worldwide. As such, there is a strong emphasis on quality and continuous improvement at Simtra. We hold ourselves to the highest quality and regulatory standards. While our primary focus is cGMP manufacturing, we offer many support services including formulation and development, lyophilization optimization, global regulatory support and secondary packaging.
Our teams are driven to help clients scale, innovate and bring life-changing medicines to patients worldwide. Make it HAPPEN – We bring a growth mindset to every opportunity, developing new skillsets and exceeding our expectations and those of our customers. Make it TOGETHER – We work as one, respecting each voice and tapping into our unique strengths across teams—so we can solve problems in new ways. Make it RIGHT – We hold ourselves to a high standard of excellence,fulfilling our commitments to the customer, their patients, and our team members. Make it COUNT – We take pride in our day-to-day work, knowing the impact we make – taking on challenges big and small to improve patient health. This role: We are looking for a Validation Media Team Associate I with a can-do attitude that is self-sufficient, has a great work ethic, and can bring new ideas to an established Sterility Assurance Team! The Media Team Associate will lead media fills, own the intervention risk management program, and communicate directly with clients and auditors. This position reports to the Supervisor, Sterility Assurance Validation. The responsibilities: Interacting directly with clients to evaluate new projects against the existing media fill process Creating documentation (gap assessments, procedures, summary reports, etc.) to support media fills at the site. These documents will be reviewed by clients and regulatory auditors. Creating and executing visual smoke testing studies to evaluate new equipment and processes. Performing and authoring investigations, process improvements, and change controls. Participate in client audits and provide rationale for validation practices with support from senior Validation team members. Provide written responses to final audit observations. Serve as the subject matter expert for up to 3 processes, technologies or process equipment. Lead fill line media challenges by planning interventions, communicating plans with other departments, providing oversight in the Fill Room, and writing the summary of the media fill. Become trained and perform semi-annual HEPA filter certification testing (integrity testing, velocity testing, visible smoke testing) Travel may be required as part of training, or equipment onboarding. Travel will be domestic and/or international. Required qualifications: Minimum Bachelor’s degree (preferably in science related discipline with laboratory experience) OR a minimum of 6 years related experience within a pharmaceutical, biotechnology or related industry including responsibilities comparable to this position (e.g., technical writing, audit experience, project lead, authoring and executing studies, etc.) Computer proficiency in Microsoft Word, Excel, and Outlook and the ability to use enterprise software (examples include: JDE, BPLM, Pilgrim, TrackWise, Ellab Valsuite Pro, etc.) Critical thinking and problem solving skills High initiative and ability to deal with ambiguity Attention to detail, ability to maintain organized workspace, and ability to communicate (oral and written) Ability to work with cross-functional teams Customer facing relations with external clientele Team and individual goal oriented Innovation and process improvement mindset Physical / safety requirements: Ability to lift 50 pounds Must be able to climb and work from ladders Must be able to qualify for 20/25 corrected vision Will require occasional overtime work, including nights and weekends Use of hands and fingers to manipulate office equipment Position requires standing for long hours but may involve walking or sitting for periods of time Ability to meet Grade A and B gowning requirements Ability to travel In return, you’ll be eligible for
Current benefit offerings are in effect through 12/31/25 Medical & Dental Coverage Flexible Spending Accounts Life and AD&D Insurance Supplemental Life Insurance Child Life Insurance Short and Long-Term Disability Insurance 401(k) Retirement Savings Plan with Company Match Time Off Program Paid Holidays Paid Time Off Paid Parental Leave and more Adoption Reimbursement Program Education Assistance Program Employee Assistance Program Community and Volunteer Service Program Employee Ownership Plan Additional Benefits Voluntary Insurance Benefits Vision Coverage Critical Illness Hospital Indemnity Insurance Identity Theft Protection Legal and more Onsite Campus Amenities Workout Facility Cafeteria Credit Union Current benefit offerings are in effect through 12/31/25 Disclaimer This job description is intended to provide the minimum knowledge, skills and abilities necessary to perform the job. It may not be inclusive of all the duties and responsibilities of the job. Simtra reserves the right to make modifications based on business requirements. Simtra is proud to be an equal opportunity employer. Simtra evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic. Interested in building your career at Simtra BioPharma Solutions? Get future opportunities sent straight to your email. Accepted file types: pdf, doc, docx, txt, rtf Enter manually Accepted file types: pdf, doc, docx, txt, rtf What are your annual salary expectations? Are you currently authorized to work in the country you are applying for?* * Select... Will you now or in the future require sponsorship? * Select... Do you have a BS degree in a science related field? Select... If you do not have a BS degree in science, do you have at least 6 years of experience in pharmaceutical industry? Select... What is your proficiency level in Microsoft Office Suite (Word, Excel, PowerPoint, Outlook, Teams, etc.) Select... Describe some examples of technical writing you have done in your career (reports, deviations, procedures, policies, instructions, etc.)? Provide specific examples. Where are you currently located? * Please list city and state. Please review the Simtra Privacy Notice and select that you have read and acknowledged the policy using the dropdown box below. * Select... Please list street, APT/Unit #, city, state, and zip code. SMS Consent: Do you agree to receive mobile messages from us in relation to this job application? Message frequency varies. Message and data rates may apply. Reply STOP to opt-out of future messaging. Reply HELP for help. View our Privacy & SMS Policy: * Select... For government reporting purposes, we ask candidates to respond to the below self-identification survey.Completion of the form is entirely voluntary. Whatever your decision, it will not be considered in the hiringprocess or thereafter. Any information that you do provide will be recorded and maintained in a confidential file. As set forth in Simtra BioPharma Solutions’s Equal Employment Opportunity policy,we do not discriminate on the basis of any protected group status under any applicable law. If you believe you belong to any of the categories of protected veterans listed below, please indicate by making the appropriate selection.As a government contractor subject to the Vietnam Era Veterans Readjustment Assistance Act (VEVRAA), we request this information in order to measurethe effectiveness of the outreach and positive recruitment efforts we undertake pursuant to VEVRAA. Classification of protected categories is as follows: A "disabled veteran" is one of the following: a veteran of the U.S. military, ground, naval or air service who is entitled to compensation (or who but for the receipt of military retired pay would be entitled to compensation) under laws administered by the Secretary of Veterans Affairs; or a person who was discharged or released from active duty because of a service-connected disability. A "recently separated veteran" means any veteran during the three-year period beginning on the date of such veteran's discharge or release from active duty in the U.S. military, ground, naval, or air service. An "active duty wartime or campaign badge veteran" means a veteran who served on active duty in the U.S. military, ground, naval or air service during a war, or in a campaign or expedition for which a campaign badge has been authorized under the laws administered by the Department of Defense. An "Armed forces service medal veteran" means a veteran who, while serving on active duty in the U.S. military, ground, naval or air service, participated in a United States military operation for which an Armed Forces service medal was awarded pursuant to Executive Order 12985. Select... Voluntary Self-Identification of Disability
Form CC-305 Page 1 of 1 OMB Control Number 1250-0005 Expires 04/30/2026 Voluntary Self-Identification of Disability Form CC-305 Page 1 of 1 OMB Control Number 1250-0005 Expires 04/30/2026 Why are you being asked to complete this form?
We are a federal contractor or subcontractor. The law requires us to provide equal employment opportunity to qualified people with disabilities. We have a goal of having at least 7% of our workers as people with disabilities. The law says we must measure our progress towards this goal. To do this, we must ask applicants and employees if they have a disability or have ever had one. People can become disabled, so we need to ask this question at least every five years. Completing this form is voluntary, and we hope that you will choose to do so. Your answer is confidential. No one who makes hiring decisions will see it. Your decision to complete the form and your answer will not harm you in any way. If you want to learn more about the law or this form, visit the U.S. Department of Labor’s Office of Federal Contract Compliance Programs (OFCCP) website at www.dol.gov/ofccp . How do you know if you have a disability? A disability is a condition that substantially limits one or more of your “major life activities.” If you have or have ever had such a condition, you are a person with a disability.
Disabilities include, for example: Alcohol or other substance use disorder (not currently using drugs illegally) Autoimmune disorder, for example, lupus, fibromyalgia, rheumatoid arthritis, HIV/AIDS Blind or low vision Cancer (past or present) Cardiovascular or heart disease Celiac disease Cerebral palsy Deaf or serious difficulty hearing Diabetes Disfigurement, for example, disfigurement caused by burns, wounds, accidents, or congenital disorders Epilepsy or other seizure disorder Gastrointestinal disorders, for example, Crohn's Disease, irritable bowel syndrome Intellectual or developmental disability Mental health conditions, for example, depression, bipolar disorder, anxiety disorder, schizophrenia, PTSD Missing limbs or partially missing limbs Mobility impairment, benefiting from the use of a wheelchair, scooter, walker, leg brace(s) and/or other supports Nervous system condition, for example, migraine headaches, Parkinson’s disease, multiple sclerosis (MS) Neurodivergence, for example, attention-deficit/hyperactivity disorder (ADHD), autism spectrum disorder, dyslexia, dyspraxia, other learning disabilities Partial or complete paralysis (any cause) Pulmonary or respiratory conditions, for example, tuberculosis, asthma, emphysema Short stature (dwarfism) Traumatic brain injury Disability Status Select... PUBLIC BURDEN STATEMENT: According to the Paperwork Reduction Act of 1995 no persons are required to respond to a collection of information unless such collection displays a valid OMB control number. This survey should take about 5 minutes to complete.
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Bloomington, Indiana, United States Simtra BioPharma Solutions (Simtra) is a world-class Contract Development Manufacturing Organization, partnering with pharmaceutical and biotech companies to bring their sterile injectable products to market. With facilities in Bloomington, Indiana, US and Halle/Westfalen, Germany, we offer a wide range of delivery systems including pre-filled syringes, liquid/lyophilized vials, diluents for reconstitution, powder-filled vials and sterile crystallization. Our product types include biologics and small molecules, cytotoxics, highly potent compounds, diluents for reconstitution and vaccines – which are all directly injected into patients worldwide. As such, there is a strong emphasis on quality and continuous improvement at Simtra. We hold ourselves to the highest quality and regulatory standards. While our primary focus is cGMP manufacturing, we offer many support services including formulation and development, lyophilization optimization, global regulatory support and secondary packaging.
Our teams are driven to help clients scale, innovate and bring life-changing medicines to patients worldwide. Make it HAPPEN – We bring a growth mindset to every opportunity, developing new skillsets and exceeding our expectations and those of our customers. Make it TOGETHER – We work as one, respecting each voice and tapping into our unique strengths across teams—so we can solve problems in new ways. Make it RIGHT – We hold ourselves to a high standard of excellence,fulfilling our commitments to the customer, their patients, and our team members. Make it COUNT – We take pride in our day-to-day work, knowing the impact we make – taking on challenges big and small to improve patient health. This role: We are looking for a Validation Media Team Associate I with a can-do attitude that is self-sufficient, has a great work ethic, and can bring new ideas to an established Sterility Assurance Team! The Media Team Associate will lead media fills, own the intervention risk management program, and communicate directly with clients and auditors. This position reports to the Supervisor, Sterility Assurance Validation. The responsibilities: Interacting directly with clients to evaluate new projects against the existing media fill process Creating documentation (gap assessments, procedures, summary reports, etc.) to support media fills at the site. These documents will be reviewed by clients and regulatory auditors. Creating and executing visual smoke testing studies to evaluate new equipment and processes. Performing and authoring investigations, process improvements, and change controls. Participate in client audits and provide rationale for validation practices with support from senior Validation team members. Provide written responses to final audit observations. Serve as the subject matter expert for up to 3 processes, technologies or process equipment. Lead fill line media challenges by planning interventions, communicating plans with other departments, providing oversight in the Fill Room, and writing the summary of the media fill. Become trained and perform semi-annual HEPA filter certification testing (integrity testing, velocity testing, visible smoke testing) Travel may be required as part of training, or equipment onboarding. Travel will be domestic and/or international. Required qualifications: Minimum Bachelor’s degree (preferably in science related discipline with laboratory experience) OR a minimum of 6 years related experience within a pharmaceutical, biotechnology or related industry including responsibilities comparable to this position (e.g., technical writing, audit experience, project lead, authoring and executing studies, etc.) Computer proficiency in Microsoft Word, Excel, and Outlook and the ability to use enterprise software (examples include: JDE, BPLM, Pilgrim, TrackWise, Ellab Valsuite Pro, etc.) Critical thinking and problem solving skills High initiative and ability to deal with ambiguity Attention to detail, ability to maintain organized workspace, and ability to communicate (oral and written) Ability to work with cross-functional teams Customer facing relations with external clientele Team and individual goal oriented Innovation and process improvement mindset Physical / safety requirements: Ability to lift 50 pounds Must be able to climb and work from ladders Must be able to qualify for 20/25 corrected vision Will require occasional overtime work, including nights and weekends Use of hands and fingers to manipulate office equipment Position requires standing for long hours but may involve walking or sitting for periods of time Ability to meet Grade A and B gowning requirements Ability to travel In return, you’ll be eligible for
Current benefit offerings are in effect through 12/31/25 Medical & Dental Coverage Flexible Spending Accounts Life and AD&D Insurance Supplemental Life Insurance Child Life Insurance Short and Long-Term Disability Insurance 401(k) Retirement Savings Plan with Company Match Time Off Program Paid Holidays Paid Time Off Paid Parental Leave and more Adoption Reimbursement Program Education Assistance Program Employee Assistance Program Community and Volunteer Service Program Employee Ownership Plan Additional Benefits Voluntary Insurance Benefits Vision Coverage Critical Illness Hospital Indemnity Insurance Identity Theft Protection Legal and more Onsite Campus Amenities Workout Facility Cafeteria Credit Union Current benefit offerings are in effect through 12/31/25 Disclaimer This job description is intended to provide the minimum knowledge, skills and abilities necessary to perform the job. It may not be inclusive of all the duties and responsibilities of the job. Simtra reserves the right to make modifications based on business requirements. Simtra is proud to be an equal opportunity employer. Simtra evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic. Interested in building your career at Simtra BioPharma Solutions? Get future opportunities sent straight to your email. Accepted file types: pdf, doc, docx, txt, rtf Enter manually Accepted file types: pdf, doc, docx, txt, rtf What are your annual salary expectations? Are you currently authorized to work in the country you are applying for?* * Select... Will you now or in the future require sponsorship? * Select... Do you have a BS degree in a science related field? Select... If you do not have a BS degree in science, do you have at least 6 years of experience in pharmaceutical industry? Select... What is your proficiency level in Microsoft Office Suite (Word, Excel, PowerPoint, Outlook, Teams, etc.) Select... Describe some examples of technical writing you have done in your career (reports, deviations, procedures, policies, instructions, etc.)? Provide specific examples. Where are you currently located? * Please list city and state. Please review the Simtra Privacy Notice and select that you have read and acknowledged the policy using the dropdown box below. * Select... Please list street, APT/Unit #, city, state, and zip code. SMS Consent: Do you agree to receive mobile messages from us in relation to this job application? Message frequency varies. Message and data rates may apply. Reply STOP to opt-out of future messaging. Reply HELP for help. View our Privacy & SMS Policy: * Select... For government reporting purposes, we ask candidates to respond to the below self-identification survey.Completion of the form is entirely voluntary. Whatever your decision, it will not be considered in the hiringprocess or thereafter. Any information that you do provide will be recorded and maintained in a confidential file. As set forth in Simtra BioPharma Solutions’s Equal Employment Opportunity policy,we do not discriminate on the basis of any protected group status under any applicable law. If you believe you belong to any of the categories of protected veterans listed below, please indicate by making the appropriate selection.As a government contractor subject to the Vietnam Era Veterans Readjustment Assistance Act (VEVRAA), we request this information in order to measurethe effectiveness of the outreach and positive recruitment efforts we undertake pursuant to VEVRAA. Classification of protected categories is as follows: A "disabled veteran" is one of the following: a veteran of the U.S. military, ground, naval or air service who is entitled to compensation (or who but for the receipt of military retired pay would be entitled to compensation) under laws administered by the Secretary of Veterans Affairs; or a person who was discharged or released from active duty because of a service-connected disability. A "recently separated veteran" means any veteran during the three-year period beginning on the date of such veteran's discharge or release from active duty in the U.S. military, ground, naval, or air service. An "active duty wartime or campaign badge veteran" means a veteran who served on active duty in the U.S. military, ground, naval or air service during a war, or in a campaign or expedition for which a campaign badge has been authorized under the laws administered by the Department of Defense. An "Armed forces service medal veteran" means a veteran who, while serving on active duty in the U.S. military, ground, naval or air service, participated in a United States military operation for which an Armed Forces service medal was awarded pursuant to Executive Order 12985. Select... Voluntary Self-Identification of Disability
Form CC-305 Page 1 of 1 OMB Control Number 1250-0005 Expires 04/30/2026 Voluntary Self-Identification of Disability Form CC-305 Page 1 of 1 OMB Control Number 1250-0005 Expires 04/30/2026 Why are you being asked to complete this form?
We are a federal contractor or subcontractor. The law requires us to provide equal employment opportunity to qualified people with disabilities. We have a goal of having at least 7% of our workers as people with disabilities. The law says we must measure our progress towards this goal. To do this, we must ask applicants and employees if they have a disability or have ever had one. People can become disabled, so we need to ask this question at least every five years. Completing this form is voluntary, and we hope that you will choose to do so. Your answer is confidential. No one who makes hiring decisions will see it. Your decision to complete the form and your answer will not harm you in any way. If you want to learn more about the law or this form, visit the U.S. Department of Labor’s Office of Federal Contract Compliance Programs (OFCCP) website at www.dol.gov/ofccp . How do you know if you have a disability? A disability is a condition that substantially limits one or more of your “major life activities.” If you have or have ever had such a condition, you are a person with a disability.
Disabilities include, for example: Alcohol or other substance use disorder (not currently using drugs illegally) Autoimmune disorder, for example, lupus, fibromyalgia, rheumatoid arthritis, HIV/AIDS Blind or low vision Cancer (past or present) Cardiovascular or heart disease Celiac disease Cerebral palsy Deaf or serious difficulty hearing Diabetes Disfigurement, for example, disfigurement caused by burns, wounds, accidents, or congenital disorders Epilepsy or other seizure disorder Gastrointestinal disorders, for example, Crohn's Disease, irritable bowel syndrome Intellectual or developmental disability Mental health conditions, for example, depression, bipolar disorder, anxiety disorder, schizophrenia, PTSD Missing limbs or partially missing limbs Mobility impairment, benefiting from the use of a wheelchair, scooter, walker, leg brace(s) and/or other supports Nervous system condition, for example, migraine headaches, Parkinson’s disease, multiple sclerosis (MS) Neurodivergence, for example, attention-deficit/hyperactivity disorder (ADHD), autism spectrum disorder, dyslexia, dyspraxia, other learning disabilities Partial or complete paralysis (any cause) Pulmonary or respiratory conditions, for example, tuberculosis, asthma, emphysema Short stature (dwarfism) Traumatic brain injury Disability Status Select... PUBLIC BURDEN STATEMENT: According to the Paperwork Reduction Act of 1995 no persons are required to respond to a collection of information unless such collection displays a valid OMB control number. This survey should take about 5 minutes to complete.
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