The Quality Assurance Validation, Specialist participates in the completion of milestones associated with specific projects and supports ongoing validation efforts and quality systems responsibilities in support of the manufacture, testing, and release of formulated drug substance. The Quality Assurance Validation, Specialist serves as the quality contact for quality projects and continuous improvement efforts regarding Validation and Quality Risk Management.
In concert with Catalent's Patient First philosophy, this role is paramount to ensure the efficacy and quality of our manufacturing processes which will ultimately yield safe drug products for patients.
- Provides guidance and appropriate oversight for the commissioning and qualification of new equipment, instruments, including major capital projects and computer systems.
- Maintains and enhances validation programs for existing equipment, utility commissioning and qualification, and computer systems.
- Assists in the development of a process validation program including assessments of Critical Quality Attributes and Critical Process Parameters.
- Drafts, reviews, executes and approves protocols and reports related to equipment, facility, method, computer, and process validation. This includes deviation reporting during execution.
- Master's Degree in technical discipline (e.g. e.g. biology, biotechnology, engineering) or related field with minimum of 4 years’ related experience; or Bachelors’ Degree in technical discipline (e.g. e.g. biology, biotechnology, engineering) or related field with minimum of 7 years’ related experience.
- Thorough knowledge of cGMP regulations related to validation including ISPE and ASTM standards.
- Experience in aseptic processing including cell culture and protein purification is preferred.
- Experience with 21 CFR Part 11 Compliance is preferred.
- Experience in process validation is preferred. Proven track record in validation and qualification of complex equipment / systems.
Catalent’s standard leadership competencies that are used to interview and for Performance & Development
- Leads with Integrity and Respect
- Delivers Results
- Demonstrates Business Acumen
- Fosters Collaboration and Teamwork
- Champions Change
- Engages and Inspires
- Coaches and Develops
- Fast tracked career growth, with annual performance review and feedback process
- Competitive base salary with other compensation incentives including yearly incentive plan
- Medical, Dental, Vision, and 401K are all offered on day one of employment
- 19 days of Paid Time Off (PTO) + 7 paid holidays
- Onsite gym, Catalent corporate discount perks, paid volunteer time off program and other benefits too numerous to mention!
- Defined career path and annual performance review and feedback process.
- Strong continued education environment with lunch and learn and mentor program