Minimum 6 years of experience in GMP validation or similar roles within a GMP environment.
10 years of GMP validation experience can substitute for a degree.
At least 3 years of experience in project leadership.
Strong leadership skills with experience in cross-functional team collaboration.
Excellent written and verbal communication skills for effective stakeholder interaction.
Deep understanding of FDA/EU/USDA regulatory frameworks relevant to biological products.
Practical knowledge in a technical discipline, such as biology.
Responsibilities
Independently draft and execute validation plans and testing strategies.
Manage regulatory compliance while balancing project priorities.
Act as a technical resource on project teams to resolve quality issues.
Provide training on quality and validation principles to staff.
Support various departments in equipment selection and system upgrades.
Develop user and functional requirements specifications for equipment.
Lead validation efforts on projects to ensure timely and compliant product launches.
Benefits
Comprehensive training in quality and validation principles.
Involvement in cross-functional projects with direct impact on product quality.
Opportunity to lead projects and mentor colleagues for professional growth.
Exposure to diverse regulatory environments and compliance issues.
Chance to work with cutting-edge technology and systems in a collaborative setting.
Full Job Description
Roles & Responsibilities:
Independently draft and execute complex validation plans, protocols, and test strategies to ensure compliance and expedited release of critical site equipment.
Balance competing priorities while ensuring global work is conducted per regulatory requirements and company procedures.
Serve on internal and external project teams (change controls, deviations, technology transfer) as a technical/compliance resource to solve quality-related issues and support continuous improvement.
Train personnel in quality and validation principles.
Support Engineering and other departments in the selection, review, acquisition, and upgrade of systems and production equipment.
Provide technical support in developing user and functional requirements specifications (URS, RA, FRS, DQ) for systems and equipment.
Act as Lead Validation representative on assigned project teams; communicate new requirements and perform training with Validation team to assure timelines are met for successful project completion and product launches.
Share quality philosophies throughout Operations and support Production and Engineering.
Perform all company business in accordance with regulations (EEO, FDA, etc.) and company policies.
Develop audit responses and complete CAPAs by target due dates; ensure Validation areas are "inspection ready" at all times.
Execute actions required to support Change Control, Deviation, and CAPA on-time closure.
Education & Experience :
Minimum 6 years GMP validation or similar experience in a GMP manufacturing/production environment.
Minimum 10 years GMP validation experience in a GMP or regulated manufacturing environment in lieu of a degree.
At least 3 years leading projects.
Ability to plan, schedule, organize, prioritize, and coordinate project activities.
Ability to function in a leadership role and within cross-functional teams.
Ability to analyze validation and production data to assess compliance with GMP requirements and troubleshoot compliance problems.
Excellent written and verbal communication skills.
Strong comprehension/application of FDA/EU/USDA regulatory requirements for production and distribution of regulated biological articles.
Strong theoretical and practical knowledge of regulated processes and one technical discipline (e.g., biology).
Ability to make decisions regarding product acceptability based on documentation.
Demonstrated ability to work with diverse groups and manage conflict.
Proficiency in MS Word, Excel, Outlook, and PowerPoint.
Bachelor's degree, preferably in a science or engineering-related field.
