Manufacturing Senior Training Coordinator
About The Position
As the Manufacturing Senior Training Coordinator, you will oversee the assignment and delivery of manufacturing training curriculums for new employees, provide hands-on instruction, and coordinate training events with supervisors. Assess the effectiveness of training, continuously improve materials in collaboration with quality and training groups, and perform personnel qualifications on critical operations such as aseptic technique and swab sampling. Maintain and report qualification status, address gaps, and support quality systems through CAPAs and Change Controls. Present the training process during audits and inspections, ensure regulatory commitments, manage the MABioOps training lab, advise on training competencies, and participate in interviewing manufacturing associate candidates as needed. You will report into the Manufacturing Manager.
Requirements
- Requires a high school diploma and 6+ years related industry experience or an Associate's Degree in Life Sciences/Engineering field with 5 years of GMP Manufacturing Experience
- Requires 5+ years of GMP Training experience.
- Experience coaching other Training Coordinators required
- Operational knowledge of upstream or downstream manufacturing including Clean-in-Place (CIP) and Steam-in-place (SIP) Systems and general production equipment such as Autoclaves, water baths, pH/Conductivity meters, etc.
- Knowledge of cGMP's and applicable agency regulations (such as the FDA, EMA) to ensure inspection readiness of department
Nice To Haves
- Biotech Certificate and prior leadership experience preferred
- Experience with systems such as SAP, LIMS and TrackWise and lean operating principles is a plus
Responsibilities
- Assign appropriate curriculum to new employees and provide a detailed overview of the manufacturing portion of the training program
- In collaboration with manufacturing supervisors schedule training events to train manufacturing personnel
- Hands-on training of manufacturing staff
- Assess training effectiveness. Work with training and quality groups to continuously improve training materials and curriculum
- Perform qualification of manufacturing personnel on critical operations including but not limited to aseptic technique and swab sampling
- Provide detailed qualification status via training reports and identify any gaps or opportunities
- Support quality systems and implement action items stemming of CAPAs and Change Controls
- Present the training process during audits and inspections
- Ability to wear personal protective equipment such as safety glasses/goggles, gloves and safety shoes
- Ability to gown and gain entry to biotechnology/pharmaceutical manufacturing areas
- Ability to lift, pull or push equipment requiring up to 25-50 lbs. of force
- Ability to stand for 6 hours in a production suite
- Ability to climb ladders and work platforms
- Stooping or bending to check or trouble-shoot equipment operations
- Ability to work around chemicals (alcohols, acids & bases)
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
Mid Level
Education Level
High school or GED
Number of Employees
5,001-10,000 employees
