Job Description

When you’re part of the team at Thermo Fisher Scientific, you’ll do important work, like helping customers in finding cures for cancer, protecting the environment or making sure our food is safe. Your work will have real-world impact, and you’ll be supported in achieving your career goals!

What you will do:

• Identify any areas where non-compliance or non-harmonization is occurring.
• Analyze data from validation tests to resolve whether systems and processes meet required criteria and specifications.
• Provide technical direction to core teams and act as customer-facing lead for project teams.
• Evaluate current and new regulations, changes to existing regulations and regulatory trends; perform gap analysis to resolve deficiencies and take appropriate actions.
• Participate in deviation investigations and supports change control assessments related to manufacturing process equipment, utilities, automation, computer systems, validation, methods, and laboratory instruments.
• Participates in multi-functional department teams for CQV efforts to meet established timeframe for project implementations that support business needs and meet global regulatory requirements.
• Support internal and external inspections for the subject matter
• Helps drive continuous quality system improvements
• Authors CQV protocols and maintains CQV SOPs, Validation Master Plans and Requalification program.
• Prepares, reviews and approves production, validation, audit reports and/or master batch record documents, procedures, and rationale
• The position involves close collaboration with Manufacturing, Manufacturing Sciences, Quality Assurance, Quality Control, and other Engineering teams.
• Perform other projects and duties as assigned by the Validation Engineering Manager/Director for the overall benefit of Thermo Fisher.
• Defends policies, procedures, rationales and methods in the area(s) of expertise during regulatory and client audits.

How you will get here

Education

• Bachelor’s degree in Engineering or Biological science related field is preferred. (High School or GED Required)
• Four (4) years of applicable experience may be considered for equivalency to education.

Experience:

• Meaningful work experience in the pharmaceutical or a regulated industry, is preferred.
• Ability to work in a fast paced environment under pressure, able to multi-task and is results-oriented.
• Effective time management and prioritization skills
• Very high degree of interpersonal skills to establish and maintain effective working relationships with employees and the public, including tact to handle sensitive matters.
• Highly effective verbal and written communication skills.

Knowledge, Skills, Abilities:

• Experience with SOP's preferred
• Knowledge of Lean Manufacturing Certification preferred
• Knowledge of Six Sigma Experience preferred
• Familiarity with a variety of concepts, practices and procedures. Outstanding attention to detail and organizational skills.
• Knowledge of cGMPs and FDA/industry expectations. Works on projects of moderate to high complexity in regards to compliance of processes and product within facilities, equipment, manufacturing and support areas.
• Ability to work multi-functionally.
• Very high degree of interpersonal skills to establish and maintain effective working relationships with employees and the public, including tact to handle critical matters. Highly effective verbal and written communication skills.

Our Mission is to enable our customers to make the world healthier, cleaner and safer. 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.

Apply today! http://jobs.thermofisher.com

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.

Accessibility/Disability Access: We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

We offer competitive salary, an annual incentive bonus plan,  401K with company match up to 6%, tuition reimbursement and a range of other employee benefits! We foster an exciting company culture that encourages innovation, forward-thinking, and an outstanding career and development prospects. Come be a part of the team!