Our esteemed client, a leader in therapeutics, renowned for their expertise in creating and manufacturing lifesaving therapies, is in search of an exceptional Associate Manufacturing Engineer to join their dynamic team.
 

• Pay: $40-42/hr.
• Terms: 6 month contract with potential for extension or conversion

What you will be doing:

• Use of MBRs and SOPs to produce clinical material from cell expansion through downstream processing in non-GMP and GMP settings.
• Support Factory Acceptance Testing (FAT) and Site Acceptance Testing (SAT) as well as equipment commissioning and validation, including associated reports and protocols.
• Assess incoming products against existing Manufacturing Ecosystem and work as part of Tech Transfer to ensure successful scale-up and process implementation.
• Work with Supply Chain and MSAT to maintain operational readiness for a variety of processing scales by identifying preferred materials for unit operations as well as acceptable substitute items.
• Update and maintain Standard Operating Procedures (SOPs) and Master Batch Records (MBRs) for process execution and equipment operations in partnership with MSAT and QA.
• Participate in investigations to determine a root cause for process deviations and author investigation reports.
• Support troubleshooting for process operations in the event of batch processing issues.

What you bring to the company:

• Bachelor of Science Degree (Engineering, Life Sciences, or related technical field) OR Associates/High School Diploma with equivalent industry experience
• 1-3 years’ experience in cGMP batch documentation and lifecycle management experience

Ability to life, or move 25-50lbs on occasion

**This job description is a complete list of all desired skills but not all are required. We strongly encourage candidates who have some of the skills to apply. We look forward to a conversation to learn more about you**

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