Process Engineer

Description

This is a temporary assignment with a potential to convert to full time at the end of 1 year.

Duties:

• 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 Client Newark campus.
• This position participates in the technology transfer process at contract manufacturing sites. This position will also work closely with internal manufacturing team and provide support in the GMP manufacturing suite as needed.
• The Process Engineer develops, establishes, and maintains quality-engineering methodologies, systems, and practices which meet internal and regulatory requirements. This position may also provide process engineering support for the Manufacturing and CapEx programs regarding new construction, equipment upgrades / retrofits / modernizations, and process improvements.

Essential Duties

• 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.

Skills: 

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