Work Schedule
Standard (Mon-Fri)
Environmental Conditions
Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Cleanroom: no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair etc... allowed,Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.)
Job Description
We are looking for a proactive Ops Training Coordinator. You will assist in developing and coordinating a robust training plan and handle documentation systems on our start-up line and maintain thereafter. Your role ensures staff are well-trained. Shift hours are 6pm - 2am, Monday-Friday
Location
Greenville, NC
Key Responsibilities:
Training Program Development:
Design, develop, and update comprehensive training programs for Steriles East operations.
Create training materials, manuals, and SOPs in collaboration with subject matter experts.
Ensure training programs meet regulatory requirements and company standards.
Training Delivery:
Conduct training sessions for new recruits and ongoing training for existing employees.
Coordinate with external trainers and consultants as needed.
Train new and current employees on tasks vital to manufacture drug products in an aseptic filling area, including but not limited to:
Cleaning cGMP Areas
Parts Preparation
Filter Integrity Testing
Operating Parts Washers and Autoclaves
Performing Tray Loading (Vial Line)
Performing Glass Loading (Vial Line)
Operating the Filling Isolator
General Material Handling
General Control Room Operations
Compliance and Documentation:
Ensure all training activities are documented, and records are maintained accurately.
Update training records and certifications as required.
Ensure training aligns with GMP and regulatory standards.
Team Leadership and Development:
Identify skill gaps and provide targeted training to address them.
Foster a positive learning environment that encourages professional growth and development.
Continuous Improvement:
Assess training effectiveness through feedback and performance metrics.
Implement improvements to training programs based on evaluation results.
Stay current with industry trends, regulatory changes, and best practices in pharmaceutical PFS.
Collaboration:
Work closely with operations, quality assurance, and human resources departments to align training with organizational goals.
Participate in cross-functional projects to enhance Steriles East operations and overall efficiency.
Education
High school diploma/GED is minimally required.
Bachelor's degree in a relevant subject area is preferred.
Experience
Required: Minimum of 2 years of experience in pharmaceutical operations, manufacturing environment or related industry.
Required: At least 1 year in a training or supervisory capacity. Other roles and responsibilities in a training or educational capacity will be considered.
Equivalent combinations of education, training, and relevant work experience may be considered.
Knowledge, Skills, Abilities
In-depth knowledge of GMP, FDA regulations, and pharmaceutical PFS standards.
Excellent communication, presentation, and interpersonal skills.
Strong organizational and project management abilities.
Proficiency in MS Office and training software.
Strong Problem-Solving Skills
Experience with Lean Six Sigma or other continuous improvement methodologies.
Familiarity with e-learning platforms and digital training tools.
What We Offer:
Compensation
Competitive Pay
Performance Related Bonus where eligible
Annual merit performance-based increase
Excellent Benefits
Medical benefits
Paid Time Off/Annual Leave
Employee Referral Bonus
Career Advancement Opportunities
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 Inc. (NYSE: TMO) is the world leader in serving science. Our mission is to enable our customers to make the world healthier, cleaner and safer. With revenues of nearly $11 billion, we have approximately 37,000 employees and serve customers within pharmaceutical and biotech companies, hospitals and clinical diagnostic labs, universities, research institutions and government agencies, as well as in environmental and process control industries. We create value for our key stakeholders through two premier brands, Thermo Scientific and Fisher Scientific, which offer a unique combination of continuous technology development and the most convenient purchasing options. Our products and services help accelerate the pace of scientific discovery, and solve analytical challenges ranging from complex research to routine testing to field applications.
All of our employees share a common set of values - Integrity, Intensity, Innovation and Involvement. Our ability to grow year after year is driven by our ability to attract, develop and retain world-class people who will thrive in our environment and share in our desire to improve mankind by enabling our customers to make the world healthier, cleaner and safer.
If you share in our values and if you're looking for an employer who is strongly committed to developing talent and rewarding achievement, come grow with us at Thermo Fisher Scientific.
Thermo Fisher Scientific is an Equal Employment Opportunity and Affirmative Action employer.