Senior Validation Project Lead/Manager
GBA Team, Baltimore, MD, United States
Current job opportunities are posted here as they become available.
Location : Virginia or Maryland or North Carolina
Compli, LLC was founded in 2001 to provide Commissioning, Validation and Regulatory Support Services to the Life Sciences industry.
We serve pharmaceutical companies across the United States, offering a vast array of services that assist companies with exceeding their goals and objectives. In today’s world, it’s never been more important to understand regulations and quality assurance activities as they relate to operations, vendors, engineering, construction and contractors. In 2020, Compli, LLC became a wholly owned subsidiary of George Butler Associates, Inc. This acquisition allowed Compli, LLC to become part of an integrated network of services where clients have more options to engage an impressive suite of in-house services.
Compli is a full service engineering contracting and consulting services company with a life sciences division specializing in pharma, biotech, API, Medical Device and laboratory facilities. We are seeking an experienced Senior/Project Lead Validation Engineer to join our growing team. Compli differentiates itself through an integrated approach to engineering, construction commissioning and validation.
What You'll Do:
Support Client commissioning / validation for facility, utility, equipment, cleaning and process validation projects
Prepare and execute commissioning / validation lifecycle documents
Participate in any stage of clinical or commercial production including green field construction, facility renovation, new product development, product launch, or product/process upgrade
Write summary reports for validation and qualification protocols
Support project milestones, priorities and deadlines
Write operating procedures for technical equipment and practices and procedures
Perform system and process risk assessments and analyses
Schedule and coordinate protocol execution with other departments including manufacturing, facilities and project management
Develop project specific validation plans and strategyAble to manage and execute multiple projects to meet client’s priorities
Provide a practical approach to problem solving
Individuals must represent Compli at client sites and interact confidently with clients, contractors, management and peers
Other duties as assigned.
What You'll Bring:
Must have minimum 7 years CQV experience with aseptic liquid fill facilities, utilities, equipment and systems.
Bachelor’s degree in a related life sciences or requisite industry training and experience
Ability to converse about scientific matters
Ability to work independently or in collaboration with others
In depth understanding and application of validation principles, concepts, practices and standards
Considered a Subject Matter Expert (SME) in one area of validation
Proficient in current Good Manufacturing Practices and other applicable regulations
Experienced with all pertinent industry best practices (e.g., ISPE) including development and execution of all applicable system life cycle deliverables (e.g., URS, SRS, FRS, DDS, RTM, Unit, Integration, User Acceptance testing, FAT, SAT, Validation Planning, IQ, OQ, PQ, Final Validation Summary Report)
Demonstrated expertise in at least one aspect of system qualification and regulatory compliance (e.g., EMEA, GCP, GLP, GMP, QSR) and internal requirements employing regulatory guidance and industry standards
Excellent written communication skills with emphasis in technical writing
Proficient in Microsoft Word, Excel, Power Point and Project
Travel : Local to Virginia or Maryland or North Carolina areas. Travel to the East Coast or Midwest for extended on-site services.
*This role is not open to C2C staffing.
It’s more than just a job…
At Compli, we are about innovative and intelligent people who want to solve problems. We’re known for our technical excellence, but we bring so much more to the table. We strive to create remarkable solutions for a higher quality of life. And we are changing the industry by integrating the design and construction process with use of new technology.
At Compli, we are an Equal Employment Opportunity Employer promoting diversity in our workforce by including all individuals regardless of age, race, religion, color, sex, national origin, marital status, genetic information, sexual orientation, gender identity, gender expression, disability, veteran status, pregnancy status, or any other status protected by law.
#J-18808-Ljbffr
Location : Virginia or Maryland or North Carolina
Compli, LLC was founded in 2001 to provide Commissioning, Validation and Regulatory Support Services to the Life Sciences industry.
We serve pharmaceutical companies across the United States, offering a vast array of services that assist companies with exceeding their goals and objectives. In today’s world, it’s never been more important to understand regulations and quality assurance activities as they relate to operations, vendors, engineering, construction and contractors. In 2020, Compli, LLC became a wholly owned subsidiary of George Butler Associates, Inc. This acquisition allowed Compli, LLC to become part of an integrated network of services where clients have more options to engage an impressive suite of in-house services.
Compli is a full service engineering contracting and consulting services company with a life sciences division specializing in pharma, biotech, API, Medical Device and laboratory facilities. We are seeking an experienced Senior/Project Lead Validation Engineer to join our growing team. Compli differentiates itself through an integrated approach to engineering, construction commissioning and validation.
What You'll Do:
Support Client commissioning / validation for facility, utility, equipment, cleaning and process validation projects
Prepare and execute commissioning / validation lifecycle documents
Participate in any stage of clinical or commercial production including green field construction, facility renovation, new product development, product launch, or product/process upgrade
Write summary reports for validation and qualification protocols
Support project milestones, priorities and deadlines
Write operating procedures for technical equipment and practices and procedures
Perform system and process risk assessments and analyses
Schedule and coordinate protocol execution with other departments including manufacturing, facilities and project management
Develop project specific validation plans and strategyAble to manage and execute multiple projects to meet client’s priorities
Provide a practical approach to problem solving
Individuals must represent Compli at client sites and interact confidently with clients, contractors, management and peers
Other duties as assigned.
What You'll Bring:
Must have minimum 7 years CQV experience with aseptic liquid fill facilities, utilities, equipment and systems.
Bachelor’s degree in a related life sciences or requisite industry training and experience
Ability to converse about scientific matters
Ability to work independently or in collaboration with others
In depth understanding and application of validation principles, concepts, practices and standards
Considered a Subject Matter Expert (SME) in one area of validation
Proficient in current Good Manufacturing Practices and other applicable regulations
Experienced with all pertinent industry best practices (e.g., ISPE) including development and execution of all applicable system life cycle deliverables (e.g., URS, SRS, FRS, DDS, RTM, Unit, Integration, User Acceptance testing, FAT, SAT, Validation Planning, IQ, OQ, PQ, Final Validation Summary Report)
Demonstrated expertise in at least one aspect of system qualification and regulatory compliance (e.g., EMEA, GCP, GLP, GMP, QSR) and internal requirements employing regulatory guidance and industry standards
Excellent written communication skills with emphasis in technical writing
Proficient in Microsoft Word, Excel, Power Point and Project
Travel : Local to Virginia or Maryland or North Carolina areas. Travel to the East Coast or Midwest for extended on-site services.
*This role is not open to C2C staffing.
It’s more than just a job…
At Compli, we are about innovative and intelligent people who want to solve problems. We’re known for our technical excellence, but we bring so much more to the table. We strive to create remarkable solutions for a higher quality of life. And we are changing the industry by integrating the design and construction process with use of new technology.
At Compli, we are an Equal Employment Opportunity Employer promoting diversity in our workforce by including all individuals regardless of age, race, religion, color, sex, national origin, marital status, genetic information, sexual orientation, gender identity, gender expression, disability, veteran status, pregnancy status, or any other status protected by law.
#J-18808-Ljbffr