Manufacturing Engineer

The ideal candidate possesses experience in Biomanufacturing with an Engineering mind and lives in the Raleigh-Durham, North Carolina area as this role is 100% onsite. You will play a critical supportive role to the Engineering team in creating and refining processes in order to improve manufacturing safety, quality, and productivity.

Please note that this is a temp to perm contract role offering a great opportunity to work within a well-respected Biomanufacturing company in RTP.

Must Have Qualifications:

Four years' experience in related engineering / validation position for GMP biologics facility.

Experience with upstream, harvest of downstream equipment (bioreactor, centrifuge, chromatography, ultrafiltration (UF), Filtration)

Validation protocol development, execution and review.

Deviation investigation, write-up, CAPA generation and other quality systems experience as SME.

Troubleshooting process equipment.

Responsibilities

Equipment protocol writing, execution, process troubleshooting, deviation investigations

Validations and CAPAs

Small capital project support and management

Training and administrative

Identify and recommend methods for improving worker efficiency and reducing waste of materials and utilities.

Collaborate cross-functionally to facilitate production process and evaluate potential changes.

Successful skills:

Independent and able to jump right in after some training.

Previous experience in areas spoken about above.

Strong collaboration and communication skills.

A huge plus if proficient in Kneat and experience with DeltaV.

Education and Experience:

BS Degree in Chemical, Bioprocessing, or Mechanical Engineering

Four years in related engineering/validation experience for a cGMP biologics facility.