Supervisor, Cleaning And Process Validation

DPT Laboratories, Ltd.
At VIATRIS, we see healthcare not as it is but as it should be. We act courageously and are uniquely positioned to be a source of stability in a world of evolving healthcare needs.
Viatris empowers people worldwide to live healthier at every stage of life.
We do so via:

• Access - Providing high quality trusted medicines regardless of geography or circumstance;
• Leadership - Advancing sustainable operations and innovative solutions to improve patient health; and
• Partnership - Leveraging our collective expertise to connect people to products and services.

Every day, we rise to the challenge to make a difference and here's how the Supervisor, Cleaning and Process Validation role will make an impact:
Key responsibilities for this role include:

• Responsible for overseeing the development and execution of cleaning validation documents, preparation and execution Cleaning Development, Cleaning Validation as well as Process Validation deliverables.
• Manage all aspects of the Cleaning Validation Life Cycle for clients from development through qualification and monitoring.
• Oversee carry-over calculations and determination of cleaning limits.
• Collaborate with management to establish and meet targets and timelines. Manage competing priorities.
• Establish work priorities and timelines for the team. Delegate assignments and organize team meetings.
• Participate in cross-functional project team, including value streams and site support groups to address specific problems, facilitate discussion and research and enable procedures to become more efficient.
• Support technology transfer activities between development and manufacturing sites as needed, ensuring successful scale-up and transfer of processes.
• Collaborate with R&D on new processes and product introductions and communicate validation requirements to ensure smooth transition between R&D to commercial.
• Schedule, plan, and disseminate tasks to support qualification / validation efforts, including assisting in process sampling, auditing and technical review functions as defined within the DPT's procedures, guidance documents and standard industry practices.
• Work interdepartmentally to assist and support scheduling qualification/validation activities.
• Provide sound rationale to validation strategies across multiple departments.
• Assess impact of change controls to qualified systems/facilities/equipment and validated products/processes.
• Provide input to revised and new policies and procedures to effectively guide validation efforts.
• Provide technical input for investigations into process/product issues and associated CAPAs in support of the qualification/validation deviations and review of design requirements for products and equipment.
• Maintain compliance with current applicable regulatory requirements and guidance, i.e., 21 CFR 210-211, EudraLex Annex 15, and any other applicable domestic and international regulations.
• Participate in regulatory inspections (i.e., FDA, EU etc.) as well as internal and corporate audits.
• Provide expertise and leadership for projects involving facility, equipment/utility qualification, and Process, packaging and/or cleaning validation. Must ensure all cGMP systems within the facility are maintained within a validated state.
• Lead and participate in the development and implementation of cross-functional initiatives.
• Provide input to the development of personal performance goals and departmental objectives. Generate and conduct semi-annual performance reviews.
• Effectively communicate expectations and objectives; motivate individuals and build team camaraderie.
• Within area of responsibility, understand and comply with all safety, environmental and quality practices and procedures as outlined in organizational/departmental guidelines and SOPs as well as applicable federal, state and local regulations.
• Maintain a state of inspection readiness.
• Train personnel and internal customers on relevant departmental processes.
• Perform other duties as assigned.

The minimum qualifications for this role are:

• Bachelor's degree in a related field (e.g., chemistry, biology, microbiology or engineering).
• Minimum of 8 years industry experience with at least 7 years direct validation/qualification experience.

At Viatris, we offer competitive salaries, benefits and an inclusive environment where you can use your experiences, perspectives and skills to help make an impact on the lives of others.
Viatris is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, national origin, religion, age, color, sex, sexual orientation, gender identity, gender expression, disability, or protected veteran status, or any other characteristic protected by local, state, or federal laws, rules, or regulations.