Position Summary
We are looking for a Validation Engineer - Insulin who will be responsible for leading the commissioning, qualification, and validation (CQV) for a client's newly announced facility expansion and provide the technical expertise to execute validation activities.
Duties & Responsibilities
- You must have a willingness to perform "hands-on" work in a dynamic, team-oriented work setting. Incumbent provides technical expertise on CQV and ensure compliance to relevant standards.
- 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.
Required Qualifications
- 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.