The validation engineer will be responsible for leading the commissioning, qualification, and validation (CQV) for a newly announced facility expansion for biologics that includes a dedicated high-speed cartridge filling line, significant utilities upgrade, dedicated formulation and processing suites, with Clean In Place (CIP) and Sanitize In Place (SIP) capabilities. Working closely with system owners and related stakeholders (operations, engineering, laboratories, IT, and quality assurance) this role will guide CQV activities to a compliant state throughout their lifecycle. This includes authoring, review, and execution of related CQV documentation as well as related documents for the role (e.g., procedures and change control records). Serves as subject matter expert for CQV activities.
ESSENTIAL DUTIES AND RESPONSIBILITIES
- Responsible for CQV activity, including all phases: requirements, validation planning, protocol generation, test execution, configuration documentation, and system release.
- Executes validation activity in a timely manner, planning and proactively pursuing details to ensure project completion without avoidable delays.
- Interpersonal skills to manage interactions and achieve results across a range of functions within the site. May also extend to external communication with system vendors.
MINIMUM QUALIFICATIONS (KNOWLEDGE, SKILLS, AND ABILITIES)
- Bachelor’s degree in engineering or relevant sciences and 7+ years of CQV experience.
- 5 years’ experience with sterile injectables, combo-devices, or biologics.
- Start-up experience preferred.
- Advanced degrees or certification relevant to the role is a plus.
- Ability to think strategically and tactically (detail-oriented).
- Strong collaborative and influencing skills, and ability to work well in a cross-functional, matrixed environment.
- Demonstrated ability to work in a fast-paced team environment, meet deadlines, and prioritize work.
- Proven track record of being self-motivated and capable of working with cross-functional teams while remaining positive towards project challenges.