Manufacturing Engineer: Validation & Protocols

Actalent; Minneapolis (MN); Presencial; USD 41.000 - 48.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Medical

Dental & Vision

401(k) Retirement Plan

HSA

Descripción de la vacante

Actalent is seeking a Manufacturing Engineer for Minneapolis, MN, to write, review, and approve qualification and validation protocols for new or transferred equipment and packaging designs. You will support CI Engineering and collaborate with engineering teams to create test plans and timelines.

You will evaluate equipment for validation requirements, perform operational testing, and develop operation and debugging procedures, all while adhering to lab protocols and regulatory requirements.

Formación

• 4-year engineering degree required and experience with life sciences equipment.
• Experience writing and executing qualification and validation protocols.
• Background in ISO or GMP biotech environments and process validation.

Responsabilidades

• Write, review, and approve qualification and validation protocols (IQ/OQ/PQ) and related reports.
• Support CI Engineering in executing equipment and packaging qualification protocols.
• Collaborate with engineering to plan test plans and timelines for new/transferred equipment.
• Evaluate equipment and packaging for validation requirements.
• Perform operational testing on small to mid-scale semi-automated equipment.
• Create operation and debugging procedures.
• Execute testing for new packaging (internal and external) including ASTM with third-party.
• Follow lab protocols, SOPs, and regulatory requirements for chemical handling and equipment use.

Conocimientos

Manufacturing equipment experience

Qualification & validation protocols

ISO/GMP biotech environment

Process validation & quality

SOP writing & troubleshooting

Educación

Bachelor's degree in Engineering

Descripción del empleo

Actalent is seeking a Manufacturing Engineer for Minneapolis, MN, to write, review, and approve qualification and validation protocols for new or transferred equipment and packaging designs. You will support CI Engineering and collaborate with engineering teams to create test plans and timelines.

You will evaluate equipment for validation requirements, perform operational testing, and develop operation and debugging procedures, all while adhering to lab protocols and regulatory requirements.