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Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates strong knowledge of current Good Manufacturing Practices (cGMP) and the ability to operate manufacturing process control systems and equipment. Capable of performing in-process analytical analysis and maintaining compliance with safety guidelines and SOPs in a team-oriented environment.
Highest-signal resume keywords
Current Good Manufacturing Practices (cGMP)Manufacturing Process Control SystemsClean In Place (CIP) Equipment OperationSAP and/or ACSIS TransactionsBioworks Certificate
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Basic Math SkillsBasic Computer SkillsMechanical AptitudeIn-Process Analytical AnalysisData EntryBuffer and Process Solutions PreparationBatch Production Records CompletionPhysical Duties PerformanceManufacturing Process MonitoringSampling Operations Assistance
Soft Skills
Detail OrientedTeam Environment CollaborationGood JudgmentExcellent Oral and Written Communication SkillsWillingness to Learn
Certifications & Qualifications
High School Diploma or EquivalentBioworks Certificate
Industry Keywords
Safety GuidelinesStandard Operating Procedures (SOPs)State and Federal Health RegulationsEnvironment and Safety RegulationsCommissioning and Validation Activities
About the role
Key responsibilities & impact- Follow company safety guidelines and programs
- Care for facility, equipment, systems, and product
- Perform personal hygiene and proper gowning
- Follow SOPs and complete Batch Production Records
- Maintain records 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 processes
- Assist with sampling operations
- Assist in harvesting intermediate products
- Prepare, set up, and transfer 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 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
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
- 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 learn from other manufacturing team members
- Ability to perform physical duties including kneeling, climbing, squatting, standing, bending, twisting, and lifting up to 50 lbs
- Ability to work at heights on platforms and ladders
- Ability to adapt to a fluid schedule during commissioning and validation
- Bioworks Certificate preferred
Benefits
Comp & perks- Regular full-time employment
- 12-hour day shift
- Internal transfer opportunities for all employees
- Equal employment opportunities
