Manufacturing Associate l
About The Position
As a Manufacturing Associate I, you will perform daily manufacturing operations according to SOPs in a cGMP environment. You will operate biologics production equipment (bioreactors, filtration units, chromatography systems and fixed/portable vessels) and will complete validation protocols. You will report to the Manufacturing Supervisor. How you will contribute: Perform dispensing, labeling, and transferring/staging of raw materials and parts. Will assemble/disassemble, clean, and sterilize components, parts, and equipment. Maintain equipment, area, and cleaning logbooks. With general management or guidance will assemble and operate biologics production equipment, such a bioreactors, filtration units, chromatography systems and fixed/portable vessels. Perform basic trouble shooting. Document cGMP data for processing steps and equipment activities while following standard operating procedures. Main documentation includes batch records, work orders, and equipment logbooks. With general management performs/or assists with processing steps and manufacturing support activities by managing process parameters in batch record and control systems. You will complete batch records and validation protocols under management/direction of others. Review equipment use logs with support. Perform inventory transactions in SAP. Perform data entry into LIMS. Perform cleaning/sanitizing production equipment.
Requirements
- High school diploma or GED.
- Knowledge of mathematical calculations (addition, subtraction, division, multiplication) and rounding.
- Can perform basic computer operations, such as ability to navigate in MS Office, use email, and complete training using Web-based Training (WBT).
Nice To Haves
- Experience in GMP environment would be ideal.
- Associates degree or higher in a scientific discipline would be ideal.
- Understanding of current Good Manufacturing Practices (cGMP) and Good Documentation Practices (GDP) would be ideal.
- Knowledge of non-manufacturing functions such as QC, Regulatory, QA, and Materials Management would be ideal.
- Prior experience with lab equipment would be ideal.
- Familiar or experience with cGMP within Biotech or Pharmaceutical operations would be ideal.
Responsibilities
- Perform dispensing, labeling, and transferring/staging of raw materials and parts.
- Will assemble/disassemble, clean, and sterilize components, parts, and equipment.
- Maintain equipment, area, and cleaning logbooks.
- With general management or guidance will assemble and operate biologics production equipment, such a bioreactors, filtration units, chromatography systems and fixed/portable vessels.
- Perform basic trouble shooting.
- Document cGMP data for processing steps and equipment activities while following standard operating procedures. Main documentation includes batch records, work orders, and equipment logbooks.
- With general management performs/or assists with processing steps and manufacturing support activities by managing process parameters in batch record and control systems.
- You will complete batch records and validation protocols under management/direction of others.
- Review equipment use logs with support.
- Perform inventory transactions in SAP.
- Perform data entry into LIMS.
- Perform cleaning/sanitizing production equipment.
Benefits
- U.S. based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others.
- U.S. based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation.
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
Education Level
High school or GED
