Job Title: Associate II, Manufacturing 

Requisition ID: 127316BR
 
 
When you’re part of the team at Thermo Fisher Scientific, you’ll do important work, like helping customers in finding cures for cancer, protecting the environment or making sure our food is safe. Your work will have real-world impact, and you’ll be supported in achieving your career goals.



Position Description/Summary:

• Responsible for cGMP manufacturing operations at the VVS Cambridge site Drug Product (DP) Fill/Finish operations.

What will you do?

• Performing basic to complex activities on the fill finish line for production of Drug Product.
• Performing critical downstream activities in preparation for fill finish of Drug Product.
• Documentation of all activities in Batch Records, Logbooks, Forms, Etc. Follows verbal and written procedures in operating production equipment and performing processing steps; accurately completes appropriate production documentation.
• Identifies, escalates and documents events and subtle variances that deviate from normal operation; participate as needed in investigations.
• Monitor processes using automated production systems and controls with limited supervision.
• Equipment preparation activities including, parts cleaning, autoclaving, and room clearance.
• Post-Fill tasks will include visual inspection, secondary packaging, and environmental monitoring.
• Daily Aseptic processing within a controlled isolator environment and within a BSC.

Additional Responsibilities:

• Work in accordance with site and company EHS programs.
• Work in accordance with regulations, detailed protocols, Batch Record’s, SOP’s and Work Instructions.
• Prepare and process components, materials and equipment for aseptic fill finish activities, operate filling equipment and perform aseptic manipulations, able to inspect finished vials and perform labeling activities to support shipment.

How will you get here?

Required Skills:

• Must be able to work in a fast-paced environment.
• A strong attention to detail through a 12-hour shift.
• Work towards solutions to given problems and operate under cGMP requirements.
• Work cross-functionally with support groups such as Facilities, Engineering, Contamination Control, Quality Control and Quality Assurance.
• Qualify to work in aseptic environments to complete required production activities.
• Maintain facility and room inspection readiness.
• Ability to lift at least 50lbs.

Work Hours: 12 hour rotating shift. May require overtime to work evenings, weekends or holidays, as required to meet project timelines.

Preferred Qualifications:

• Bachelor’s Degree with 1-3 years of industry related experience in cGMP manufacturing.
• High School diploma and 2-4 years’ industry related experience in cGMP manufacturing.
• Independently motivated and can work within a cross-functional team

At Thermo Fisher Scientific, each one of our 65,000 extraordinary minds has a unique story to tell. Join us and contribute to our singular mission—enabling our customers to make the world healthier, cleaner and safer.