What are the responsibilities and job description for the Life Science Consultant with Fill/Finish Expertise position at Bothwell Engineering Inc.?
About the Role:
We seek skilled life science consultants to support a growing site in New Jersey. Utilizing fill/finish equipment expertise, you will provide essential technical guidance commissioning and qualifying fill/finish lines. Multiple roles are available to support the startup of the Fill/Finish lines. Expertise with fill/finish operations, including authoring and executing IOQ protocols, is required.
Key Responsibilities:
- Support the startup of Formulation, Fill & Finish processes in a growing, cGMP-compliant environment.
- Author and execute IOQ protocols for Fill/Finish and clean utilities systems.
- Collaborate with cross-functional teams to ensure operational readiness.
- Ensure compliance with cGMP standards and industry best practices.
Qualifications:
- Education: BS in a relevant science or engineering discipline.
- Experience: 2-3 years in biopharmaceutical operations, with substantial involvement in cGMP environments.
- Specific Certifications or Training: Experience with cGMP practices and fill/finish equipment is crucial.
- Skills: Demonstrated ability to work independently, problem-solve effectively, and lead in cross-functional settings.
- Location: Ability to work on-site in New Jersey.
Please refer to the Scope of Work and Key Responsibilities sections above for specific tasks and duties related to the role.
Scope of Work Includes:
- Steriline Start-Up Cx
- Steriline VHP Development
- VHP PQ – Protocol development, execution, and reporting
- Washer IOQ and PQ – Various volumes (5mL, 10mL, 30mL)
- Tunnel IOQ, PQ, and RQ – Protocol development, execution, and reporting
- Depyro PQ – 5mL, 10mL, and 30mL protocols
- Filler/Capper IOQ and PQ – 5mL, 10mL, and 30mL protocols
- Isolator RQ – Protocol development, execution, and reporting
- SCADA – Protocol development, execution, and reporting
- Vessel IOQ – 24L, 100L, and 150L protocol development
- Hold, Transfer, and Filling PQ – Protocol development, execution, and reporting
- COP – Cleaning Out of Place activities
Why Join Us?
At Bothwell Engineering Inc., we are trusted advisors who help our clients tackle their most complex challenges. We optimize processes, ensure compliance, and drive innovation for transformative outcomes. Our team works collaboratively to bridge knowledge gaps and deliver actionable solutions that make a real impact. We pride ourselves on our deep industry connections, ensuring project success and professional satisfaction.
The work is contract-based, but hired candidates can choose to be onboard either as contractors or full-time employees, depending on their preference.
Join us for a rewarding opportunity with comprehensive benefits (401K, medical, dental, vacation, and sick days), and the chance to accelerate patients' health and contribute to meaningful life science projects.
Ready to make a difference and shape the future of life sciences?
www.bothwellengineering.com