Manager, Manufacturing Training

Simtra BioPharma Solutions (Simtra) is a world-class Contract Development Manufacturing Organization partnering with pharmaceutical and biotech companies to bring their sterile injectable products to market. With facilities in Bloomington Indiana US and Halle/Westfalen Germany we offer a wide range of delivery systems including pre-filled syringes liquid/lyophilized vials diluents for reconstitution powder-filled vials and sterile crystallization.

Our product types include biologics and small molecules cytotoxics highly potent compounds diluents for reconstitution and vaccines which are all directly injected into patients worldwide. As such there is a strong emphasis on quality and continuous improvement at Simtra. We hold ourselves to the highest quality and regulatory standards.

While our primary focus is cGMP manufacturing we offer many support services including formulation and development lyophilization optimization global regulatory support and secondary packaging. Our teams are driven to help clients scale innovate and bring life-changing medicines to patients worldwide.

Why join Team Simtra Because we:

Make it HAPPEN We bring a growth mindset to every opportunity developing new skillsets and exceeding our expectations and those of our customers.

Make it TOGETHER We work as one respecting each voice and tapping into our unique strengths across teamsso we can solve problems in new ways.

Make it RIGHT We hold ourselves to a high standard of excellencefulfilling our commitments to the customer their patients and our team members.

Make it COUNT We take pride in our day-to-day work knowing the impact we make taking on challenges big and small to improve patient health.

This role:

The Manager Manufacturing Training is responsible for leading the execution and continuous improvement of training programs across manufacturing operations. This role ensures employees are equipped with the knowledge and skills to meet regulatory quality and operational standards while fostering a culture of learning and operational excellence. The Manager oversees a team of Manufacturing Trainers and partners with Manufacturing Quality HR and other stakeholders to deliver effective compliant and engaging training experiences. Additionally this role contributes to strategic workforce development initiatives and supports audit readiness.

The responsibilities:

• Lead the development and continuous improvement of the technical aspects of manufacturing training.
• Supervise coach and develop a team of Manufacturing Trainers across multiple shifts and departments (e.g. Prep Formulation Filling Capping Packaging Inspection).
• Foster a culture of continuous learning and professional growth within the training team.
• Coordinate training schedules onboarding programs and ongoing learning initiatives to support manufacturing readiness.
• Ensure training content is current accurate and aligned with SOPs regulatory requirements and operational needs.
• Apply adult learning principles and instructional design best practices to enhance training effectiveness and engagement.
• Maintain accurate training records and ensure alignment with GMP GDP and regulatory standards.
• Support audit readiness and lead training-related CAPA initiatives when gaps are identified.
• Monitor training completion compliance and effectiveness using Learning Management Systems (LMS) and other tools.
• Assist in developing and tracking KPIs to measure training impact and recommend improvements based on data analysis.
• Partner with leadership to forecast workforce skill needs and develop proactive training strategies.
• Collaborate with Manufacturing Operational Excellence and HR to integrate new equipment processes and career pathways into training programs.
• Drive innovation in training delivery including digital learning tools VR/AR/AI simulations and microlearning approaches.
• Promote a safe inclusive and engaging learning environment that supports employee development and performance.

The work environment:

• Ability to work in cleanroom environments and wear appropriate PPE.
• Occasional lifting (up to 25 lbs) standing and walking in manufacturing areas.
• Flexibility to support multiple shifts and occasional weekend or evening work as needed.

Required qualifications:

• Bachelors degree required.
• 35 years of experience in a regulated manufacturing environment (pharmaceutical biotech or similar) preferred.
• 2 years of experience in a training or leadership role.
• Knowledge of instructional design adult learning theory and training evaluation methods.
• Familiarity with GMP GDP and regulatory compliance in manufacturing.
• Strong communication facilitation and organizational skills.
• Proficiency in Microsoft Office and enterprise systems (e.g. LMS JDE Trackwise BPLM).

Preferred qualifications:

• Experience with Lean Manufacturing Six Sigma or Operational Excellence methodologies.
• Certification in training or instructional design (e.g. ATD CPTD).
• Familiarity with digital learning platforms and e-learning authoring tools.

In return youll be eligible for1:

• Day One Benefits
  • Medical & Dental Coverage
  • Flexible Spending Accounts
  • Life and AD&D Insurance
  • Supplemental Life Insurance
    • Spouse Life Insurance
    • Child Life Insurance
  • Short and Long-Term Disability Insurance
  • 401(k) Retirement Savings Plan with Company Match
  • Time Off Program
    • Paid Holidays
    • Paid Time Off
    • Paid Parental Leave and more
  • Adoption Reimbursement Program
  • Education Assistance Program
  • Employee Assistance Program
  • Community and Volunteer Service Program
  • Employee Ownership Plan
• Additional Benefits
  • Voluntary Insurance Benefits
    • Vision Coverage
    • Accident
    • Critical Illness
    • Hospital Indemnity Insurance
    • Identity Theft Protection
    • Legal and more
  • Onsite Campus Amenities
    • Workout Facility
    • Cafeteria
    • Credit Union

1 Current benefit offerings are in effect through 12/31/25

Disclaimer

This job description is intended to provide the minimum knowledge skills and abilities necessary to perform the job. It may not be inclusive of all the duties and responsibilities of the job. Simtra reserves the right to make modifications based on business requirements.

Equal Employment Opportunity

Simtra is proud to be an equal opportunity employer. Simtra evaluates qualified applicants without regard to race color religion gender national origin age sexual orientation gender identity or expression protected veteran status disability/handicap status or any other legally protected characteristic.

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Manager