Thermo Fisher Scientific Supervisor, Manufacturing Validation in Florence, South Carolina
Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue exceeding $25 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, improving patient diagnostics and therapies or increasing productivity in their laboratories, we are here to support them.
Our global team of more than 75,000 colleagues delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services and Patheon. For more information, please visit www.thermofisher.com .
How will you make an impact?
Reporting to the Manager, Manufacturing Projects, this role manages the execution of qualification, validation, and equipment cleaning protocols. The role has supervisory responsibility for 3 to 5 non-exempt Manufacturing Specialists.
What will you do?
Lead day to day equipment cleaning, qualification, and process validation activities. Assist Technical Manager to develop validation strategy. Assist in campaign preparations.
Assist with the generation of lifecycle documents including P&IDs, impact assessments, criticality assessments,
Quality Risk Assessments Author protocols and summary reports.
Maintain knowledge of industry standards as applied to field of Systems Qualification, Cleaning, and Process Validation.
Provide training site-wide or to selected employees as needed to support program goals.
Interface with clients and auditors (FDA, EMA, etc.) as necessary.
Assist in Process and Technology Transfers. Resolve high level issues for complex investigations, CAPAs, change requests, and engineering projects.
Administer, document and maintain such in accordance with the Patheon Quality Systems and tools.
Ensure Regulatory Compliance.
Carry out supervisory responsibilities in accordance with the organization's policies and applicable laws.
Responsibilities include interviewing, hiring and training employees; planning, assigning and directing work; appraising performance; rewarding, developing and disciplining employees; addressing complaints and resolving issues.
Perform other duties as required.
How will you get there?
To competently perform this job, a candidate will need the knowledge and skills generally obtained with a degree in Chemical Engineering or a related field.
10+ years' related experience.
Equivalent combinations of education, training, and relevant work experience may be considered.
Knowledge of regulatory requirements which includes: FDA, EPA/DHEC and OSHA. Basic knowledge of statistical process control including Lean concepts, and Microsoft Office tools (including MS Project). Ability to interpret P&IDs, engineering drawings, engineering specifications, vendor manuals, etc. Excellent oral, written and presentation/communication skills; ability to interact effectively with all levels of employees; ability to multi-task and work under tight deadlines.
At Thermo Fisher Scientific, each one of our 70,000 extraordinary minds has a unique story to tell. Join us and contribute to our singular mission-enabling our customers to make the world healthier, cleaner and safer.
Thermo Fisher Scientific is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, creed, religion, color, national or ethnic origin, citizenship, sex, sexual orientation, gender identity and expression, genetic information, veteran status, age or disability status.