What are the responsibilities and job description for the Bioprocess Engineer position at The Steely Group?
In this role, you will be responsible for supporting the Operations team by implementing and executing manufacturing processes in a regulated, controlled environment.
You will have opportunities to participate in various projects and initiatives in addition to these primary responsibilities:
Responsibilities:
- Support the Operations team in drug substance and/or drug product manufacturing.
- Help draft technical documentation for drug product and drug substance manufacturing.
- Assist the Operations team with environmental monitoring, cleaning programs, and inventory management.
- Maintain manufacturing areas and process components to ensure a clean, safe and organized work environment.
- Work collaboratively with and support the Development Lab and Quality teams.
- Follow standard operation procedures (SOP) and work instructions to execute tasks.
Requirements / Qualifications:
- Bachelor’s degree required
- Minimum 2 years working in manufacturing or laboratory operations is required.
- Able to work in a clean room environment environment is required.
- Pharmaceutical or Medical Device industry experience is required.
- Knowledge of FDA, cGMP, and ICH regulatory requirements is required.
- Must be well organized, attentive to detail and have effective verbal and written communication skills.
- Must be able to efficiently prioritize, manage and complete multiple projects and tasks in a fast-paced environment.
