Responsibilities:
- Perform routine and critical manufacturing operations in Cell Culture, Purification, Solution & Equipment Prep areas
- Operate production equipment per SOPs for clinical and commercial products
- Troubleshoot/process issues; recognize and escalate deviations
- Implement critical/routine production activities
- Complete Batch Records, Log Books, and Form Prep requests; review GMP documentation
- Prepare samples and perform testing
- Enter data in LIMS/MODA or other business systems
- Initiate work orders; assemble/disassemble process equipment
- Perform scheduled equipment cleaning and standardization; support changeover activities
- Identify documentation changes needed; participate in tiered visual management and support CI plans
- Support equipment/process qualifications and validation
Qualifications/Requirements:
- High school diploma with 0+ years experience OR Associateβs Degree in Life Sciences/Engineering
- Proficient following written instructions (Batch Records, Form Preps, Technician Protocols/Procedures)
- Aseptic Technique proficiency; full awareness of current GMPs
- Proficient computer skills
- Biotech certificate is ideal
Work/Environment Considerations:
- Controlled environment with protective gowning; remove makeup/jewelry/contact lenses/nail products
- Cold/wet environment; multiple shifts/weekends; possible supplemental hours
- Work around chemicals; may need respiratory protection
- Lift/pull/push up to 25β50 lbs.; stand ~6 hours; climb ladders/platforms
Application:
- By clicking βApply,β you acknowledge commencement of the employment application process.