CDMO, CMO, Contract Development and Manufacturing Organisation

Technical Training Specialist - Manufacturing

Job Title
Technical Training Specialist - Manufacturing
Location
Germantown,  WI 53022
Other Location
Description
Summary of Role
The Technical Training Specialist II is accountable for driving results in a fast-paced environment by overseeing technical training activities, as part of the quality management system, for an assigned work group within Sterling.  Activities include the development of custom training modules and materials based on a needs assessment of skills required to successfully perform jobs in the organization and changing c
ompliance requirements; will present and monitor completion and success of technical training programs for new hires and current employees.

Essential Functions

  • Directly oversees the site On-the-Job Training (OJT) program. Facilitates OJT program needs with management and outside vendors. Facilitates trainer program and conducts trainer assessments. Performs on-the-job training with qualified Trainers on equipment/instrument set-up and troubleshooting.
  • Develops and updates training requirements through job code reviews with manufacturing, quality, and site support departments. Coordinates development and updating of OJT skill check assessment checklists.
  • Creates instructor led and computer-based training courses using best training resources and practices.
  • Assesses training and training program content adequacy and needs. Implements continuous improvements to technical training programs, curricula, offerings, courses and/or any other training related material.
  • Analyzes training trends and reviews quality data to determine opportunities for continuous improvement.
  • Prepares and manages the technical training calendar and communication board.  Facilitates scheduling of OJT courses.
  • Oversees training documentation requirements, completions, rosters, certificates, and compliance.
  • Tracks and reports key quality indicators, training metrics, and participant feedback.
  • Adheres to all environmental, health and safety SOPs, equipment, policies and procedures, including any department specific requirements.
  • Stays current with applicable regulations including federal, state, local and company-specific practices.
  • Sustain a clean and safe work area using 5S principles.
  • Learn, understand and apply rigorous quality standards, Standard Operating Procedures (SOPs) and Current Good Manufacturing Practices (cGMP).
  • Ensures timely completion and compliance with cGMP and all other relevant company training requirements.
  • An individual in this position must be able to successfully perform the essential duties and responsibilities listed above. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions of this position.

Education and Experience

  • Bachelor's degree in a life science, training and development or related field or equivalent experience.
  • Master’s degree preferred.
  • 5+ years of relevant experience.
  • 2+ years of technical training experience, including developing curriculum and writing course content.
  • 2+ years of experience advising and influencing internal stakeholders (leadership, technical trainers, etc.).
  • Prior pharmaceutical or CDMO industry experience required.

Key Competencies

  • Knowledge of cGMP and quality management systems.
  • Knowledge of MS Word, PowerPoint, Excel, Outlook.
  • Knowledge of instructional design, blended learning and contemporary learning methodologies.
  • Awareness of and ability to learn emerging learning technologies (LMS technologies, Adobe Flash, Captivate, etc.).
  • Excellent written and verbal communication and interpersonal skills.
  • Excellent attention to detail, good problem solving and analytical skills.
  • Excellent training, facilitation and project management skills.
  • Customer orientation, teamwork skills and the ability to actively commit to, support and participate in continuous improvement activities.
  • Ability to understand verbal and written safety and quality instructions; read and comprehend written work instructions including words and drawings.
  • Ability to manage multiple priorities.
  • Ability to manage, adapt to and influence change in a dynamic, high pressure environment.
  • Ability to coach and influence internal key stakeholders.
  • Candidates need to be competent with IT systems, and Microsoft Office including Outlook, PowerPoint, Word and Excel.
  • Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job.  
  •  Duties, responsibilities and activities may change at any time with or without notice. 

Diversity and Inclusion

Sterling values diversity and we are committed to creating an inclusive environment for all employees.  All employment decisions are based on business needs, job requirements and individual qualifications, without regard to race, color, religion, sex, pregnancy, age, national origin, physical or mental disability, past or present military service, marital status, gender identification or expression, medical condition (including genetic characteristics) or any other protected characteristic as established by law.

Why consider Sterling?

Sterling Pharma Solutions is a global contract development and manufacturing organisation (CDMO) with more than 50 years’ experience in developing and manufacturing Active Pharmaceutical Ingredients (APIs).  This is complimented by Antibody Drug Conjugate (ADC) research and development bioconjugation services.

We are a fast growing, dynamic business with facilities in the UK and the US, where we employ more than 800 talented and passionate people who support our customers in bringing new medicines to market, improving and saving the lives of patients.

Our culture and our way of working is what really sets us apart as a business; we aim to deliver an exceptional experience to our customers and our employees.  You can expect to be part of a supportive team, all working towards a shared goal: to deliver first-class science and service to our customers every day. 

 

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