Manager Equipment Validation

2 months ago

Whitby, Canada Thermo Fisher Scientific Full time

As part of the Thermo Fisher Scientific team, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world’s toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer.

**How will you make an impact?**

Manages the equipment validation staff (internal & third party) to meet customer and client requirements and provides standards and direction to the site and clients in meeting Good Manufacturing Practices (GMP) requirements in the area of Equipment Validation. Interacts cross functionally to resolve equipment validation issues, ensures proper documentation, and completes all equipment validation documentation to meet the Manufacturing Production Schedule (MPS). Additional duties include Deviation Report (DR) inputs, client or vendor equipment validation protocols and reports approval.

**What you will do**:

- Mentors, guides and coaches the department team from a technical perspective to increase level of knowledge and expertise.
- Seeks and brings ideas with regards to automation, industry benchmark and Regulatory guidelines to support site growth, efficiency and compliance.
- Supports Corporate equipment validation activities such as Data Integrity (DI) and Continuous Process Verification (CPV).
- Participates in strategy meetings with other departments to develop Equipment Validation guidelines.
- Plans, prioritizes and implements all equipment validation projects.
- Reviews equipment validation protocols and creates/updates Standard Operating Procedures (SOPs) for the department.
- Works with the Business Management team to support client relationships regarding equipment validation issues.
- Schedules and manages day-to-day activities in the department as wells prepares and circulates departmental activity reports and schedules.
- Coordinates equipment validation activities with other departments to insure project completion and timeliness.
- Provides input in the preparation of project proposals and budgets for equipment validation activities.
- Provides input in investigations and attends meetings discussing commercial processes with ongoing problems.
- Selects, develops and evaluates staff to ensure the efficient operation of the function. Works with and advises staff on administrative policies and procedures. Recommends changes in staffing and budgets as needed. Staff may include internal and third parties.
- Supports and resources Capital Engineering Projects, PPI, and New Business needs with respect to Equipment Validation

**How will you get here?**

**Education**:
Bachelor’s degree in engineering

P. Eng. is preferred.

**Experience**:
Minimum 7 years’ previous combined experience in Project Management and Equipment Validation in a cGMP regulated environment

Minimum 5 years previous supervisory experience.***
**Equivalency**_:_ _

Equivalent combinations of education, training, and relevant work experience may be considered.

**Knowledge, Skills, Abilities**:
Strong mechanical understanding of Manufacturing equipment. Strong knowledge and understanding of manufacturing/operational processes. Excellent knowledge of Good Manufacturing Practices and Food and Drug Administration (FDA) compliance knowledge. Strong interpersonal and communication skills (both oral and written). Ability to motivate and influence. Ability to meet deadlines and prioritize multiple project deliverables. Comfortable dealing with all levels in the organization. Capable of setting clear priorities, organizing work, and making quality decisions in a fast-paced business setting. Demonstrated computer proficiency with Microsoft Office programs. Proficiency with the English language.

Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one global team of 100,000 colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory at Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.

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