Brammer Bio, LLC is a dynamic gene and cell therapy contract development and manufacturing organization that is looking for leaders to bring the highest quality processes, products and testing to our clients. Our staff members are committed to making a difference in our organization, for our client partners and the patients we serve. We seek individuals with proven competencies and strong character to help lead our organization now and into the future.
The Sr Specialist, Engineering Training will report directly to the site Engineering Associate Director. The Sr Specialist utilizes expert knowledge of the site s training system and department s operating procedures and practices to design, maintain, and continuously improve the department s role based curriculum / curriculum architecture to enhance the organization s knowledge base through effective and efficient training programs. The Specialist will also assist in creating, maintaining, and updating area procedures and training materials.
- Practices and promotes safe work habits and adheres to safety policies and procedures.
- Utilizes knowledge of manufacturing procedures, processes, and theory to identify and resolve training / knowledge issues, improve training effectiveness, and enhance training program.
- Partners with manufacturing managers and supervisors to establish training curriculum structures and strategies.
- Reviews department s training documentation for compliance with Training SOPs and Good Documentation Practice (GDP), generates curriculum forms, and performs Training Impact Assessment (TIA).
- Schedules and coordinates training activities for department; delivers training to area staff.
- Coaches / mentors department trainers; observes and evaluates trainer candidates for qualification.
- Creates training reports and generates KPI metrics and trends from Plateau.
- Acts as liaison between department and Operations Development and Training (D&T).
Thermo Fisher offers an attractive benefit package to all full time employees which includes; medical, dental, and vision coverage, company paid Disability and Life Insurance benefits, and a 401(k) Plan with a generous company match. All full time employees are also provided with paid time off, paid company holidays, and an incentive bonus plan.
Thermo Fisher is an Equal Opportunity Employer and participates in eVerify.
- Exhibits strong interpersonal and communication skills and the ability to work effectively with a wide range of constituencies in a diverse community.
- Provides effective written or verbal communication to peers, manufacturing staff, and area management within their operational group.
- Technical understanding of mechanical systems, GMP processes, or process equipment needed to aid in technical conversations and investigations.
- Proficient at public speaking, teaching, facilitating to peers, engineering staff, and area management within their operational group.
- Recognize, understand and respond to situations requiring further evaluation and report these events (process, safety, personnel, etc..) to manufacturing or area management.
EDUCATION AND QUALIFICATIONS:
- Bachelor's degree and 6-8 years of related work experience or Master s degree and 4-6 years of work experience. Preferred experience working in 2 or more functional areas.
- Minimum of 3 years in cGMP operations, engineering or maintenance teams in fast paced production environment.
- Demonstrated ability to manage cross-functional teams and collaborate across the business.
- Demonstrated ability to present ideas persuasively and negotiate effectively.
- Excellent written and oral communication skills both internal and external.
While performing the duties of this job, the employee:
- Ability to function in a dynamic environment and balance multiple priorities simultaneously.
- Ability to learn new software and tools quickly.
- Ability to make decisions and work with minimal to moderate supervision.
- Ability to aseptically gown and/or sterile gown as needed.
- While performing the duties of this job, the employee is required to 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.
- Is 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.
Note: This job description is not all-inclusive. Additional duties may be performed, as assigned. It acts as a guideline and is subject to change over time.
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