Reporting to the Manufacturing Department Supervisor, the training coordinator is responsible for the following:
- 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.
- Accountable for presenting training process during audits and inspections. Accountable for implementation of regulatory commitments
- Train manufacturing personnel on manufacturing operations and Lean manufacturing systems. Maintain and revise training material to support effective training
- Ensure documentation is complete, reviewed and meets good documentation practices
- Recommend/Implement process or safety improvements
- Help identify training needs
- Support deviation investigations as an SME
- Complete action items for GMP investigations and CAPA s
- Revise training material as necessary
- Communicate any quality issues/concerns to Supervisor and QA
- Support regulatory inspections and commitments
- Provide timely feedback on staff s performance
- Ensure staff compliance with all relevant SOPs, BR, FP and safety guidelines during training
- Act as a role model (Lead by Example)
- Act as a resource/SME for staff
- Ensure the use of safe work practices and behaviors
Education and Experience Requirements:
- Normally requires a high school diploma and 6+ years related industry experience or an Associates Degree in Life Sciences/Engineering field with 5 years of GMP Manufacturing experience. Biotech Certificate and prior leadership experience preferred.
- Experience with systems such as SAP, LIMS and TrackWise and lean operating principles is a plus.
Key Skills, Abilities, and Competencies:
- 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.
- Good interpersonal skills and ability to work in a team environment
- Effective communication skills to all levels throughout the organization
- Demonstrates appropriate level of adaptability, maintains positive outlook, and demonstrates composure under pressure.
- Self motivated individual with the ability to complete and manage training multiple individuals and projects concurrently.
- Flexibility to work according to the production schedule. This position may require weekend, and overtime work at times.
- 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).
Complexity and Problem Solving:
- The incumbent will be responsible for technical problem solving and recommending efficiency and/or operational improvements.
- Internal and External Contacts
- All Internal Manufacturing, Training, Materials Management Facilities Management and Health, Safety & Environment with limited exposure to support groups (Validation, Quality Control, etc).
- Will require minor external contact with equipment and supply item vendors.
Notice to Employment / Recruitment Agents:
Employment / Recruitment agents may only submit candidates for vacancies only if they have written authorization to do so from Shire, a wholly-owned subsidiary of Takeda s Talent Acquisition department. Any agency candidate submission may only be submitted to positions opened to the agency through the specific Agency Portal. Shire, a wholly-owned subsidiary of Takeda will only pay a fee for candidates submitted or presented where there is a fully executed contract in place between the Employment / Recruitment agents and Shire, a wholly-owned subsidiary of Takeda and only if the candidate is submitted via the Agency Portal. Candidates submitted or presented by Employment / Recruitment Agents without a fully executed contract or submitted through this site shall not be deemed to form part of any Engagement for which the Agency may claim remuneration.
Equal Employment Opportunity
Shire, a wholly-owned subsidiary of Takeda, is an Equal Opportunity Employer committed to a diverse workforce. Shire, a wholly-owned subsidiary of Takeda, will not discriminate against any worker or job applicant on the basis of race, color, religion, gender, national origin, ancestry, age, sexual orientation, marital or civil partnership status, pregnancy, gender reassignment, non-job related mental or physical disability, genetic information, veteran status, military service, application for military service, or membership in any other category protected under law.
EEO is the Law - https://www.dol.gov/ofccp/regs/compliance/posters/pdf/eeopost.pdf
EEO is the Law Supplement - https://www.dol.gov/ofccp/regs/compliance/posters/pdf/OFCCP_EEO_Supplement_Final_JRF_QA_508c.pdf
Pay Transparency Policy - https://www.dol.gov/ofccp/pdf/pay-transp_formattedESQA508c.pdf
Shire, a wholly-owned subsidiary of Takeda, is committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please call 484-595-8400 and let us know the nature of your request and your contact information.