Process Engineer II (Framingham, MA)
The Engineer III is a technical leader who is a member of the Project Engineering team and is accountable for the design, support and troubleshooting of upstream and downstream bioprocessing equipment. The Engineer III is expected to have the technical expertise to serve as an SME for multiple systems. The person in this role is expected to have a good working knowledge of cGMP requirements and the ability to apply this knowledge and develop ideas independently across multiple technical areas.
- Function as a technical expert on equipment or systems; lead troubleshooting of operations, develop preventative maintenance procedures, and maintain engineering documentation.
- Execute concurrent projects of moderate scope and complexity, with minimal supervision.
- Interpret and execute policies and procedures. Recommend modifications to operating policies.
- Execute tasks, under the minimal direction of project managers, to complete design, engineering, construction, commissioning, and qualification for projects within schedule and budget constraints.
- Coordinate the work of consultants, and engineering firms on development of standard design documents.
- Develop project scopes, schedules and budgets.
- Obtain and critique quotes for system/facility modifications and work with the vendor to execute.
- Lead initiatives and/or projects.
- Utilize quality systems to ensure compliance with regulatory requirements.
- Partner with peers, team members, direct and indirect management chain to ensure the following:
- Ensure Inspection Readiness of assigned areas
- Participate in timely completion of investigations, deviations and CAPA
- Provide support for documentation changes
- Develop and manage change controls
- Bachelor's degree in Engineering with 6+ years Industry experience in a GMP environment.
- Working knowledge of pharmaceutical/biotech processes.
- Direct experience in the Biopharmaceutical industry designing supporting and troubleshooting Upstream and Downstream process equipment.
- General understanding and wide application of technical principle, theories, and concepts in the Biotech/Pharmaceutical field.
- General knowledge of other related disciplines(i.e. Automation , I&C).
- Demonstrated skills in the following areas:
- Problem solving and applied engineering
- Basic technical report writing
- Working knowledge of specialized equipment/processes.
- General knowledge of Commissioning and Qualification.
- Effectively interact with a variety of communication and working styles.
Sthree US is acting as an Employment Business in relation to this vacancy.