Position Title: Process Engineer (MSAT)

Work Location: Newark, California

Assignment Duration: 12 Months

Position Summary:

• Client is seeking a Temporary Process Engineer (MSAT) to work with manufacturing at Contract Development and Manufacturing Organizations (CDMOs) as well as internal manufacturing support at the Newark campus.

• This position participates in the technology transfer process at contract manufacturing sites.

Key Responsibilities:

• Work cross-functionally with key stakeholders to support upcoming technology transfer process to CDMO partners.

• Draft, revise, and update technical documents for manufacturing and technology transfer.

• Support process optimization, qualification, and new process development efforts.

• Participate in solution and equipment preparation and production activities at Newark facility during critical runs as required.

• Perform routine procedures following written instructions (SOPs, batch records, protocols).

• Review in-process and executed documents for accuracy and ensure batch records are turned in to area management within specified days of completion.

• Collaborate with departments to ensure compliance activities are executed efficiently and effectively, and in accordance with all governing documents and regulatory guidelines.

• Contribute to continuous process and quality improvement efforts to conform to regulatory requirements and industry standards.

• Applies sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.

• Assist in troubleshooting of process/plant equipment.

• Support and/or perform investigations / deviations from an engineering/maintenance perspective and help with data for timely closure of deviations, change controls and CAPAs.

• Ensure compliance with GMP regulations, procedures, and standards as appropriate for the role.

• Acts as an effective team member in supporting quality disciplines, decisions, and practices.

• Support internal and external audits.

• Other related duties as assigned.

Qualification & Experience:

• 2+ years of experience in GxP regulated manufacturing/lab environment.

• Requires good verbal and written communication skills.

• Experience operating or working knowledge of major manufacturing equipment is required (e.g. fermenter, TFF skids, vial filler, vial capper, RABs system, lyophilizer, glass washer, autoclave, etc.).

• Experience with GxP, SOPs, and clean room operation required.

• Ability to work both independently and collaboratively, with excellent communication and organizational skills. Promotes information sharing, facilitates groups to ensure open discussion.

• Must be able to adhere to all applicable procedures, cGMPs, company policies and any other quality or regulatory requirements. (For example: OSHA, DEA, FDA, CDC, HS&E, etc.).

• Ability to analyze and resolve problems independently.

• Ability to identify issues and seek solutions.

• Impeccable attention-to-detail.

• Great time-management skills and ability to work in a fast-paced environment.

• Performance of tasks essential to the job function may require the employee to work directly with, handle, or otherwise come into contact with chemicals or pharmaceutical agents (including potent compounds).

• Ability to climb ladders and lift up to 50 lbs.

• Aseptic operation experience is preferred.

Education:

• Minimum of bachelor’s degree in biology, biochemistry, engineering (chemical/biochemical), pharmaceutical sciences or other relevant life science fields.

 
 
At SPECTRAFORCE, we are committed to maintaining a workplace that ensures fair compensation and wage transparency in adherence with all applicable state and local laws. This position’s starting pay is: $ 48.64/hr.