Project Engineer (R-PEP) Pharmaceutical Technology

Project Engineer (R-PEP) Pharmaceutical Technology

Location: Rochester, Michigan

Position Summary:

MCP is currently seeking a dynamic individual to fill our Pharmaceutical Technology Project Engineer position. This candidate will be responsible for technical transfer and product development project planning, protocol development and execution, process/equipment modification evaluations, contract customer work, and troubleshooting technical support issues with existing MCP and contract customer products.

Works independently, completing project activities with little or no supervision. Will perform the role of the technical transfer project leader, mentoring less experienced colleagues. Plans, writes, executes and documents engineering study protocols and final reports, process development plans, and Technical Reports. Adheres to and promotes current Good Manufacturing Practices (cGMP). Provide technical expertise as necessary to support plant goals. Collaborate with peers. Provide consultation and interface between various departments, as needed.

Essential Functions / Key Results Areas :

Responsible for development, planning, and execution of technical transfer project plans and engineering study protocols/final reports for transferring and supporting new and existing product manufacturing processes.

  • Coordinates department, manufacturing, and laboratory schedules necessary to accommodate technical transfer and development activities associated with assigned development projects.

  • Performs special projects as assigned by department manager / director.

  • Participates in evaluating and recommending new equipment or process changes that will result in cost reduction or quality improvement.

  • Provides technical assistance to Engineering, Maintenance, and Production in troubleshooting and resolving problems associated with manufacturing processes.

  • Evaluate, recommend and requisition materials and equipment necessary for pursuance and completion of development projects.

  • Demonstrates independence and professionalism in the execution of projects.

  • Adheres to department deadlines, expectations, and project priorities, and develops realistic goals for timely completion of departmental projects.

  • Assesses, evaluates, and performs testing necessary to accomplish project goals in a timely manner.

  • Independently develops departmental standard operating procedures and associated job aids where necessary.

  • Adheres to all company and current Good Manufacturing Practices (cGMP).

Minimum Requirements: Education / Qualifications / Certifications: BS in a science related field with 5 to 10 years pharmaceutical or laboratory experience; or equivalent combination of education and experience.

If you possess the required background and are interested in being a member of the team, submit your resume and a cover letter on the online application

About MCP Pharmaceuticals, LLC:

MCP Pharmaceuticals is an integrated specialty healthcare company that specializes in sterile injectable products. MCP manufactures and sells brand aseptic injectable pharmaceuticals in hospital and clinical settings and provides contract manufacturing services for global pharmaceutical companies.

MCP’s own product portfolio includes leading diagnostic, women’s health and anesthesia products. All products have a long track record of “gold standard” service and are at or near the front line of treatment in their therapeutic indications. Contract manufactured products include some of the leading global biologic products which involve liquid, lyophilized and suspension presentations.

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