Manufacturing Associate II
About The Position
This Manufacturing Associate II, DP Operations builds on core cGMP experience, performing routine unit operations—including formulation, filtration, aseptic filling within isolators, and downstream visual inspection. This role ensures material and component readiness, performs enhanced in-process controls, and keeps equipment within defined parameters while documenting contemporaneously in MES/eBR. The associate works under moderate supervision and contributes to operational efficiency through adherence to SOPs, collaboration across functions, and active participation in a clean and compliant manufacturing environment. Success is measured by plan attainment, documentation accuracy, right-first-time execution, and effective knowledge sharing.
Requirements
- Associates or Bachelors Degree in a Scientific field or a High School Diploma with equivalent experience.
- 2-4 years in GMP manufacturing or similar environment preferred; we will train strong entry-level candidates.
- Comfortable working in cleanrooms with full gowning and standing for extended periods; able to lift up to ~35 lbs.
- Basic computer skills (batch records, training systems).
- Must have 20/20 vision (corrected vision allowed – i.e., glasses, contact lens) and maintain the ability to see all colors across the visible spectrum. A vision test will be required upon hiring to confirm vision acuity and will be administered annually thereafter.
- Reliable, detail-oriented, follows instructions, communicates clearly, and works well on a team.
- This position requires availability to work a 12-hour night shift from 6:00 PM to 6:00 AM, including flexibility to support operational coverage, cross-training, overtime, weekends, and holidays as business needs require.
Responsibilities
- Perform formulation, sterile filtration, vial/syringe filling, and visual inspection in accordance with SOP’s and cGMP requirements.
- Conduct equipment checks, material staging, aseptic line clearances, and routine facility/equipment cleaning using approved disinfectants.
- Complete accurate, contemporaneous, and compliant ALCOA+ documentation, including logbooks and electronic batch record (eBR) entries.
- Perform required in-process checks, accurately record results, and ensure compliance with established specifications and procedures.
- Identify and promptly escalate deviations, atypical events, and equipment issues; support troubleshooting and investigations by providing relevant data and statements.
- Support the development and revision of SOPs and work instructions and implement continuous improvement opportunities.
- Maintain strict adherence to cGMP, gowning, aseptic behavior, safety, and documentation requirements while maintaining a clean and safe operating environment.
- Complete required training, maintain qualifications and skills matrices, and train/mentor peers to support team capability and compliance.
- Collaborate effectively with QA, QC, MS&T, Facilities, Supply Chain, and other cross-functional partners during routine operations and issue resolution.
- Work effectively in a fast-paced, cross-functional manufacturing environment, demonstrating flexibility to support cross-training, operational coverage, off-hours, and overtime as needed.
Benefits
- Competitive healthcare, plus voluntary benefit programs to support your unique needs
- A holistic approach to well-being, with access to fitness, mindfulness, and mental health support
- Family planning benefits, including fertility, adoption, and surrogacy support
- Generous paid time off, including vacation, volunteer days, sabbatical, global recharge days, and a discretionary year-end shutdown
- Savings and investments to help you plan for the future
- Location-specific perks and extras
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
Education Level
Associate degree
