Position Description, Functions, Duties and Tasks: Position Summary: The Manufacturing Training Coordinator plays a critical role in ensuring operational training excellence, safety, and regulatory compliance across the manufacturing facility. Reporting directly to the API or Drug Product Manager, this position leads the design, standardization, and execution of site and area training programs, provides training guidance to the area SME Trainers, drives Continuous Improvement (CI) initiatives, and acts as a lead technical writer for training materials. The ideal candidate is a high-energy, self-directed problem solver with a strong background in training program development and management in a regulated chemical, pharmaceutical, or process manufacturing environment. Responsibilities: Training - Standard Operating Procedures (SOPs): Create, update (practice vs procedure) and distribute procedures/modules/JFC’s to manufacturing personnel.
- Employee Onboarding and Training: Onboard new operations personnel, conduct needs assessments via SME input and workplace observations, and execute hands-on competency validations. Complete routine check-ins.
- Communication: Maintain effective communication with the Operations/Manufacturing managers, shift leaders and support staff to ensure adherence to protocols and standards
- Team Collaboration: Actively participate in area team meetings and project teams.
- Qualification Plans: Develop and facilitate employee qualification plans and partner with production leaders to ensure employees remain in qualified status.
- Train-the-Trainer Programs: Facilitate Train-the-Trainer certification programs to empower Supervisors and Subject Matter Expert Trainers (SMETs) to deliver consistent, high-quality training.
Continuous Improvement - Performance Gap Identification: Monitor shop-floor operations and evaluate training data to identify skill deficiencies, operational bottlenecks, and efficiency opportunities.
- Quality & Work Standardization: Develop and implement department-wide quality control measures and standardized work routines to minimize variance.
- Project Implementation: Act as a champion for Continuous Improvement (CI) initiatives, new operational tools, and site-wide process optimizations.
- Operational Support: Assist Operations Managers in planning, developing, and coordinating plant-wide activities to minimize operational disruptions.
Deviation Investigator/Quality Compliance - Technical Writing Support: Provide technical writing support for non-routine investigations rooting in human error or training inadaquacies.
- Deviation Management: Support the operational implementation of deviation-specific countermeasures.
Minimum Qualification (Education, Experience and/or Training, Required Certifications): Education: Associate Degree in Engineering, Technical Science, or a related discipline (or equivalent relavent experience). Experience: Minimum of 3–5 years of experience in a chemical, pharmaceutical, or regulated process manufacturing environment. Core Experience: Proven track record in developing, delivering, and evaluating workforce training programs. Proven proficiency in manufacturing processes and equipment is required. The successful candidate must be capable of serving as a subject matter expert, providing training, mentorship, and technical guidance to trainees and team members. Skills: - Technical Writing: Superior ability to translate complex manufacturing processes into clear SOPs, SWIs, technical investigation reports, and training guides.
- Software & Systems Proficiency: Proficiency in ERP systems (SAP preferred), Quality Management Systems (e.g., SESuite), MS Office Suite (Word, Excel, PowerPoint, Teams), and Adobe.
- Methodology Expertise: Knowledge of Job Instruction Training (JIT), Standard Work Instructions (SWIs), Root Cause Analysis (RCA) techniques and TAP Root.
- Interpersonal & Coaching: Strong public speaking, facilitation, and coaching abilities to engage cross-functional teams and manufacturing associates.
Additional Preferences: - Manufacturing background
- Additional technical training
- Knowledge of API/Drug Product process areas and cGMPs
- Familiarity with DCS and PLC automation systems
- Familiarilty with data historian
- Experience as a deviation investigator and CAPA management.
- Green Belt Certification or CI Certification
What do we offer? - Competitive Salary
- Competitive Benefits Package and Employee Assistance Program
- 401(k) Plan + Company Match
- Vacation + End of Year Vacation (Company Sponsored)
- Growth Opportunities to expand your career
|