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Thermo Fisher Scientific Manufacturing Training Specialist II in Lexington, Massachusetts

Job Title: Manufacturing Training Specialist II

Requisition ID: 166405BR

Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue exceeding $25 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, improving patient diagnostics and therapies or increasing productivity in their laboratories, we are here to support them.

At Viral Vector Services (VVS) a division of Thermo Fisher Scientific we deliver, from process development through commercial supply, we offer the expertise and resources necessary to help clients deliver innovative gene therapies. Placed in the forefront of our leading and cutting edge Cell and Gene Therapy business enabling clients to cure genetic, rare, and otherwise untreatable diseases.

Location/Division Specific Information:

45 Hartwell Avenue, Lexington MA

How will you make an impact?

The training specialist in this role will be part of a cohesive team responsible for ensuring the development and delivery of an effective department training program. The selected candidate will collaborate and coordinate with Area Management and Specialists to design, develop and implement sustainable cGMP competency-based training to ensure a well-trained workforce is compliant with company procedures and regulatory expectations. Routinely collaborates with Learning and Development (L&D) for program requirements with respect to training strategy guidance, as well as for content design and review.

What will you do?

  • Work with Department Management and Specialists to assess training needs, and to develop, run, and maintain training programs within the department.

  • Design, develop and manage cGMP competency-based Learning Plan roll-out and on-boarding across the department's organization.

  • Review training material generated to align with network standard learning objectives and providing feedback to SME's as required.

  • Facilitate initial training impact assessments for document changes and workflows to aid in determining training requirements, aligning with training program requirements.

  • Plan and deliver site training courses, as required. Coordinate training with instructors on behalf of department.

  • Support new procedural updates ensuring training can be adjusted, implemented and delivered in a timely manner.

  • Champion Learning & Development (L&D) initiatives and educate internal clients on the L&D program requirements.

  • Support Regulatory inspections, client, and global audits as the Functional Area Training Specialist on site.

  • Collaborate with training administrators identified across the network and ensure alignment to network strategic objectives.

  • Develop Key Performance Indicators (KPI) and measurement criteria to assess effectiveness of training program and monitor compliance metrics to enable accurate and timely reporting of key learning metrics. Present Training metrics at Leadership Meetings where relevant.

  • Provide department competency completion status, to identify resource capability.

  • Act as a Champion for Global training initiatives to be implemented on site, within department.

  • Support and develop consistent training standards for use within cGMP manufacturing.

  • Apply industry best Human Performance concepts to help customers determine when training is appropriate to solve problems vs. other solutions.

  • Participates in initiatives to support innovation and continuous improvement activities, including digital solutions to achieve learning objectives.

  • Improve compliance within training program procedures, policies, and regulations.

  • Participate in client and planning meetings as requested. Including but not limited to presentation and document preparation.

How will you get here?

Education:

  • Bachelor's Degree in Life Sciences or Adult Education and a minimum of 5 years' experience in pharmaceuticals manufacturing or cGMP regulated industry.

  • OR, Associates Degree or equivalent, and minimum of 7 years' experience in pharmaceuticals manufacturing or cGMP regulated industry.

Experience:

  • Ability to function in a fast paced, dynamic environment with multiple priorities simultaneously

  • Strong planning, organization and multitasking skills

  • Strong interpersonal and communication skills and the ability to work effectively with a wide range of constituencies in a diverse community.

  • Ability to make decisions and work with minimal to moderate supervision.

  • Able to provide effective written or verbal communication to peers, senior associates, and area management within their operational groups

  • Solid understanding of applicable regulatory

Knowledge, Skills, Abilities:

  • Gown aseptically and/or sterile gown as needed.

  • Write, read/review written documentation for extended periods of time. Specific vision requirements for this job include close vision, distance vision, color vision, peripheral vision, depth perception, and ability to adjust focus.

  • Regularly required to talk and hear. The employee frequently is required to sit and stand for extended periods.

  • The employee is occasionally required to lift, stand; walk; use hands to finger, handle, or feel; reach with hands and arms; and stoop, kneel, or crouch.

At Thermo Fisher Scientific, each one of our 70,000 extraordinary minds has a unique story to tell. Join us and contribute to our singular mission-enabling our customers to make the world healthier, cleaner and safer.

Apply today! http://jobs.thermofisher.com

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.

Thermo Fisher Scientific is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, creed, religion, color, national or ethnic origin, citizenship, sex, sexual orientation, gender identity and expression, genetic information, veteran status, age or disability status.

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