Manufacturing Supervisor - Night Shift
Takeda Pharmaceuticals, Round Lake, IL, United States
Production Supervisor
As a Production Supervisor, you will implement and supervise activities in the production area at Takeda's Round Lake, Illinois manufacturing facility, to ensure manufacturing goals and project deadlines are met while maintaining compliance with current good manufacturing practices (cGMPs), environmental health and safety (EHS) guidelines and any other regulations that could apply; focus is on optimization in the use of raw materials, equipment and employees in producing quality products; may monitor and oversees labor and capital expenditures; may assist in developing budgets; recommends manufacturing policies, procedures and programs.
Provide guidance, support, direction, and leadership through positive interactions with all employees during daily operations.
Supervise the day-to-day production, scheduling, staffing, material management, compliance, training and auditing activities
to meet customer requirements including deadlines and quality standards.
Interview, hire, coach, motivate, develop and discipline staff; conduct annual performance reviews for all team members; assist in setting performance objectives and development plans; monitors progress.
Review, approve, and manage documentation for batch and system records; assists in release of product for distribution; assists in meeting product release time goals.
Emphasize training programs designed to enable staff to consistently execute all manufacturing processes with strict compliance to cGMPs and EHS regulations.
Develop and implement performance measurement and internal auditing programs in order to routinely evaluate operation efficiency and quality; implements changes as needed based on assessments.
Perform/lead technical review, investigation and process improvement projects; provides manufacturing input into integration and validation of new equipment and processes.
Resolves technical, material and cGMP problems that may impact project deadlines; provides guidance and troubleshooting assistance as needed during a deviation in the process.
Represent the company during FDA inspections; provides information as necessary to FDA that establishes credibility and demonstrates compliance with cGMPs.
Perform daily gemba walks to engage with employees and ensure their following proper safety practices.
High School Diploma or GED plus 4+ years of related experience OR Bachelors' degree in science, engineering or other related technical field and 2+ years of related experience. Some leadership experience preferred.
Demonstrated interpersonal and leadership skills with ability to interface well with other departments and lead effectively and efficiently in a team environment.
Experience working in an FDA regulated environment preferred. In-depth process knowledge of related manufacturing equipment and processes.
Ability to manage multiple priorities in a manufacturing plant setting.
Ability to analyze and interpret scientific and statistical data.
Have strong teamwork and communication skills, both verbally and written, good documentation skills, customer oriented, work safely and effectively under stressful conditions.
Strong professional writing skills and ability to prepare technical reports.
Experienced understanding of cGMPs and other regulatory guidelines applicable to the medical/pharmaceutical industry.
Strong assessment and troubleshooting skills.
Ability to respond to detailed inquiries, and present information to groups and senior management.
May be required to supervise multiple groups/shifts.
Good computer skills. Proficient in MS Word, MS Excel.
At Takeda, our patients rely on us to deliver quality products. As a result, we must follow strict rules in our manufacturing facilities to ensure we are not endangering the quality of the product. In this role, you may:
Work in a controlled environment requiring special gowning and wear protective clothing over the head, face, hands, feet and body. This may include additional hearing protection for loud areas.
Need to remove all make-up, jewelry, contact lenses, nail polish and/or artificial fingernails while in the manufacturing environment.
Work in a cold, wet environment.
Work multiple shifts, including weekends, or be asked to work supplemental hours, as necessary.
Work around chemicals such as alcohol, acids, buffers and Celite that may require respiratory protection.
Must be willing and able to work aligned shift.
In general, the position requires a combination of sedentary work and walking around observing conditions in the facility.
Must be able to carry up to 30 lbs., lift up to 30lbs, push/pull up to 30lbs (with assistance of material handling equipment).
Must be able to stand and/or walk for an extended period over an 812-hour shift between rooms and across the site.
Indoor working conditions.
Will work around moving equipment and machinery.
Must be able to work overtime as required.
May be required to work in a confined area.
Some Clean Room and cool/hot storage conditions
At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work.
Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.
USA - IL - Round Lake - Drug Delivery
Employee
Regular
Full time
Job Exempt
Yes
As a Production Supervisor, you will implement and supervise activities in the production area at Takeda's Round Lake, Illinois manufacturing facility, to ensure manufacturing goals and project deadlines are met while maintaining compliance with current good manufacturing practices (cGMPs), environmental health and safety (EHS) guidelines and any other regulations that could apply; focus is on optimization in the use of raw materials, equipment and employees in producing quality products; may monitor and oversees labor and capital expenditures; may assist in developing budgets; recommends manufacturing policies, procedures and programs.
Provide guidance, support, direction, and leadership through positive interactions with all employees during daily operations.
Supervise the day-to-day production, scheduling, staffing, material management, compliance, training and auditing activities
to meet customer requirements including deadlines and quality standards.
Interview, hire, coach, motivate, develop and discipline staff; conduct annual performance reviews for all team members; assist in setting performance objectives and development plans; monitors progress.
Review, approve, and manage documentation for batch and system records; assists in release of product for distribution; assists in meeting product release time goals.
Emphasize training programs designed to enable staff to consistently execute all manufacturing processes with strict compliance to cGMPs and EHS regulations.
Develop and implement performance measurement and internal auditing programs in order to routinely evaluate operation efficiency and quality; implements changes as needed based on assessments.
Perform/lead technical review, investigation and process improvement projects; provides manufacturing input into integration and validation of new equipment and processes.
Resolves technical, material and cGMP problems that may impact project deadlines; provides guidance and troubleshooting assistance as needed during a deviation in the process.
Represent the company during FDA inspections; provides information as necessary to FDA that establishes credibility and demonstrates compliance with cGMPs.
Perform daily gemba walks to engage with employees and ensure their following proper safety practices.
High School Diploma or GED plus 4+ years of related experience OR Bachelors' degree in science, engineering or other related technical field and 2+ years of related experience. Some leadership experience preferred.
Demonstrated interpersonal and leadership skills with ability to interface well with other departments and lead effectively and efficiently in a team environment.
Experience working in an FDA regulated environment preferred. In-depth process knowledge of related manufacturing equipment and processes.
Ability to manage multiple priorities in a manufacturing plant setting.
Ability to analyze and interpret scientific and statistical data.
Have strong teamwork and communication skills, both verbally and written, good documentation skills, customer oriented, work safely and effectively under stressful conditions.
Strong professional writing skills and ability to prepare technical reports.
Experienced understanding of cGMPs and other regulatory guidelines applicable to the medical/pharmaceutical industry.
Strong assessment and troubleshooting skills.
Ability to respond to detailed inquiries, and present information to groups and senior management.
May be required to supervise multiple groups/shifts.
Good computer skills. Proficient in MS Word, MS Excel.
At Takeda, our patients rely on us to deliver quality products. As a result, we must follow strict rules in our manufacturing facilities to ensure we are not endangering the quality of the product. In this role, you may:
Work in a controlled environment requiring special gowning and wear protective clothing over the head, face, hands, feet and body. This may include additional hearing protection for loud areas.
Need to remove all make-up, jewelry, contact lenses, nail polish and/or artificial fingernails while in the manufacturing environment.
Work in a cold, wet environment.
Work multiple shifts, including weekends, or be asked to work supplemental hours, as necessary.
Work around chemicals such as alcohol, acids, buffers and Celite that may require respiratory protection.
Must be willing and able to work aligned shift.
In general, the position requires a combination of sedentary work and walking around observing conditions in the facility.
Must be able to carry up to 30 lbs., lift up to 30lbs, push/pull up to 30lbs (with assistance of material handling equipment).
Must be able to stand and/or walk for an extended period over an 812-hour shift between rooms and across the site.
Indoor working conditions.
Will work around moving equipment and machinery.
Must be able to work overtime as required.
May be required to work in a confined area.
Some Clean Room and cool/hot storage conditions
At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work.
Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.
USA - IL - Round Lake - Drug Delivery
Employee
Regular
Full time
Job Exempt
Yes