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About the role
Key responsibilities & impact- Follow company safety guidelines and programs
- Care for facility, equipment, systems and product
- Maintain personal hygiene and proper gowning
- Follow SOPs and complete Batch Production Records
- Complete record keeping according to current Good Manufacturing Practices
- Operate manufacturing process control systems and equipment
- Operate Clean In Place (CIP) equipment
- Perform in-process analytical analysis
- Monitor manufacturing process status
- Assist with sampling operations
- Assist in harvesting intermediate products
- Assist with preparation, setup and transfer of buffer and process solutions
- Transfer intermediate product, raw materials and waste
- Stage plasma, intermediate paste and raw materials
- Clean and sanitize designated manufacturing areas
- Utilize SAP and/or ACSIS transactions
- Support production supply-chain requirements
- Assist team members, including supervision, with additional tasks
- Manufacture safe human-use drug products ethically and compliantly
- Execute commissioning and validation activities for a new building
- Complete assignments supporting departmental objectives
- Communicate with operators, technicians and supervisors
- Work rotating night shifts in a laboratory/manufacturing environment
Requirements
What you’ll need- Basic math skills
- Basic computer skills
- Mechanical aptitude
- Detail-oriented
- Ability to work in a team environment and exercise good judgment
- High school diploma or equivalent required
- Bioworks Certificate preferred
- Level II advancement typically requires a minimum of 12 months as a Technician in the respective department
- Level II advancement requires a minimum rating of meets expectations overall on the most recent performance review
- Knowledge of company safety guidelines and SOPs
- Strong knowledge of current Good Manufacturing Practices (cGMP)
- Knowledge of State and Federal Health, Environment and Safety regulations
- Excellent oral and written communication skills
- Ability to work a 24/7 rotating shift schedule
- Comfortable using different computer systems for data entry
- Willingness to work with and learn from other manufacturing team members
- Desire to enhance skills and knowledge
- Ability to kneel, climb, squat, stand, bend and twist
- Ability to perform frequent repetitive hand movements
- Ability to lift and carry up to 50 lbs.
- Ability to work at heights on platforms and/or ladders
- Ability to adapt to a fluid schedule during commissioning and validation
Benefits
Comp & perks- Equal employment opportunities in accordance with applicable laws
- Personal protective equipment provided/required, including protective eyewear, garments and gloves