Manufacturing Engineer - North Carolina, United States - Randstad Enterprise

Description

The ideal candidate possesses experience in Biomanufacturing with an Engineering mind. 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.