Senior/Principal CQV Engineer
| Company | Beam Therapeutics |
|---|---|
| Location | Cambridge, MA, USA, Durham, NC, USA, Research Triangle, Durham, NC, USA |
| Salary | $Not Provided – $Not Provided |
| Type | Full-Time |
| Degrees | Bachelor’s, Master’s, PhD |
| Experience Level | Expert or higher |
Requirements
- Bachelors or Advanced degree in an engineering or scientific discipline.
- 12+ years’ experience in the biopharmaceutical/biotech industry supporting internal manufacturing and testing operations in a validation or technical operations/engineering capacity.
- Excellent verbal and written English language communication skills, detail-oriented personality, and ability to work and drive change across functions.
- Solid knowledge of global facility, utility, equipment and computer system regulations and standards; experience interacting with regulatory health authorities at pre- and post-approval inspection is preferred.
- Strong team player that has a customer service approach and is solution oriented.
- Attention to detail and the ability to work individually, within a multi-disciplinary team, as well as with external partners and vendors.
- Excellent team building, leadership and management skills.
- Excellent listening, communication and interpersonal skills fostering team spirit.
- Consistent delivery of on-time high-quality work.
- Ability to gown and enter clean rooms (i.e. GMP manufacturing spaces).
Responsibilities
- Provide leadership to both sites on the various aspects of a compliant CQV program to support both capital projects and maintenance of the validated state for facilities, utilities, equipment and computerized systems, including analytical instruments.
- Support key capital projects, providing routine updates on CQV progress and support issue escalation and resolution.
- Support implementation of a validation package periodic review/re-evaluation program for assets at both sites.
- Assist CQV Managers with CQV estimates for capital projects or significant Opex initiatives.
- Lead continuous improvement initiatives for the overall CQV program.
Preferred Qualifications
- Project Management experience and skills preferred.
- Experience supporting CQV work for small and large capital projects preferred.
- Experience supporting periodic review / requalification/reevaluation programs for facilities, utilities, equipment and computerized systems preferred.
- Experience with Lifecycle management software, experience with Kneat preferred.