What are the responsibilities and job description for the Bioprocess Specialist position at The Steely Group?
Position Title: Bioprocess Operations Specialist – GMP Manufacturing
Position Overview:
We are seeking a skilled and motivated Operations Specialist to support GMP manufacturing of drug substance and drug product in a regulated environment. This role will work cross-functionally to execute manufacturing processes, maintain facility readiness, and uphold the highest standards of quality and compliance. Ideal candidates have hands-on bioprocessing experience in a cleanroom setting and are looking to grow in a fast-paced biotech environment.
Key Responsibilities:
- Execute GMP manufacturing operations—upstream and/or downstream—according to approved batch records and SOPs.
- Support equipment preparation, area setup, batch execution, and in-process monitoring.
- Draft and review GMP documentation, including batch records, work instructions, deviations, and change controls.
- Maintain cleanroom and equipment readiness, including environmental monitoring and materials management.
- Collaborate with cross-functional teams including Quality, Development, and MS&T to support production and tech transfer.
- Contribute to investigations and continuous improvement initiatives related to manufacturing performance and compliance.
Qualifications:
- Education:
- Bachelor’s degree in Bioprocess Engineering, Chemical Engineering, Biotechnology, or related discipline.
- US Citizenship or a Green Card
- Minimum 2 years of hands-on experience on GMP biologics manufacturing floor
- Familiarity with aseptic techniques, single-use systems, and cleanroom protocols.
Technical & Regulatory:
- Strong knowledge of FDA, cGMP, and ICH requirements.
- Comfortable working in Grade B/C cleanroom environments.
- Experience with electronic batch records and automated systems a plus.
