Manufacturing Associate – cGMP, Cleanroom, Bioprocess
- The Manufacturing Associate will be responsible for safe and efficient sterile manufacturing steps in support of all Good Manufacturing Practices (GMP) Operations
- Media/ buffer prep. The Manufacturing Associate will execute the preparation of media/ buffer solutions utilizing disposable mixing technology, raw material sampling and submission, and preparation of process equipment using a washer and autoclave.
- Hands-on support with sterile manufacturing/ GMP manufacturing equipment to support commercial manufacturing.
- Review/revision of SOPs and Master Batch Record (MBR) instructions to improve operational accuracy and efficiency.
- Execute SAP transactions in a commercial environment.
- Equipment troubleshooting product and equipment issues and deviations.
- Reporting, investigation, and resolution of Deviations, Change Control, and Corrective/ Preventive Actions (CAPA)
- Interact cross-functionally with Downstream/ Upstream Operations, Facilities, R&D, Quality Assurance (QA), Quality Control (QC), Validation, and other internal and external functions to support successful manufacturing campaigns.
- Compliance. Strict adherence with cGMP, ICH, EMA and JP Guidelines and industry safety standards/OSHA guidelines.
- Responsible for completing assigned tasks which include cleaning, sterilizing, and prepping glassware and parts used in the manufacturing environment.
- Equipment Preparation within the specified training curriculum.
MEDIA PREP/ STOCK SOLUTIONS:
- Media preparation, filtration, sterile pipetting, CIP, SIP, and rigorous inventory management
- Work with an ERP system and an MES system.
- Completing required training in all areas of Stock Solutions within the specified training curriculum.
- Weighing/Measuring (Sub-aliquoting/aliquoting) powders and liquids into smaller containers
- Using ERP system and MES system, obtain materials for manufacturing operations
- Follow a production schedule.
- Inventory/ Stock management
- Make recommendations to maximize efficiency and productivity based on shift needs.
- Completing training in all areas of Pre-weigh within the specified training curriculum.
- High School (HS) diploma, with some college-level coursework in Biological/, Physical Sciences or at least 2 years of relevant experience; BA/BS in Life Sciences/Physical Sciences or equivalent preferred.
- Minimum of 1-3 years’ experience in buffer/media support operations at a pharmaceutical or biotechnology company
- Working within a cleanroom environment: Gowning, hospital scrubs, coveralls, gloves, and steel toe boots.
- cGMP Technician must have a high standard for safety and the highest level of attention to detail
- Knowledge of international (21CFR, EMEA, and JP) cGMP regulations.
- Knowledge of SAP Process systems as used in a regulated manufacturing environment (not IT SAP role)
- Knowledgeable in weigh, dispense, and sampling procedures for controlled raw materials
- GMP operation knowledge - production equipment (washers, autoclaves, disposable mixing technology for media and buffer solutions.
- Must possess good troubleshooting, electro-mechanical aptitude, interpersonal communication and team skills.
- Cleanroom work support requiring staff to wear a full gown/coverall (Gowning –high-density polyethylene fibers)
- No makeup or jewelry can be worn when working in the cleanroom environment.
- No jewelry or makeup allowed in the production area including earrings and fake nails, eyelashes
- Continuous improvement and safety. Identify, investigate, and resolve basic process and equipment problems.
- Flexibility to multi-task and adjust to varying priorities to meet timelines and schedule changes in Support Operations.
- Self-starter with a strong focus on detail, safety, quality and results. Strong written and verbal communication skills.
- Possess proficiency in business applications including inventory control systems.
- Able to be flexible in work assignments, work weekends, off shifts and overtime as required.
- SHIFT FLEXIBLE must be able to work 12 hour
Opportunity is Calling, Apply Now!
What’s In It for You?
We welcome you to be a part of one of the largest global staffing companies to meet your career aspirations. Yoh’s network of client companies has been employing professionals like you for over 65 years in the U.S., UK and Canada. Join Yoh’s extensive talent community that will provide you with access to Yoh’s vast network of opportunities and gain access to this exclusive opportunity available to you.
- Medical, Dental & Vision Benefits
- 401K Retirement Saving Plan
- Life & Disability Insurance
- Direct Deposit & weekly ePayroll
- Employee Discount Programs
- Referral Bonus Programs
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