Validation Engineer II

Thermo Fisher Scientific•Greenville, NC

20d•Onsite

About The Position

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. Excellent Benefits Package Review our company’s Total Rewards Medical, Dental, & Vision benefits-effective Day 1 Paid Time Off & Holidays 401K Company Match up to 6% Tuition Reimbursement – eligible after 90 days! Employee Referral Bonus Employee Discount Program Recognition Program Charitable Gift Matching Company Paid Parental Leave Career Advancement Opportunities Location/Division Specific Information Greenville, NC RELOCATION ASSISTANCE IS NOT PROVIDED Must be legally authorized to work in the United States WITHOUT SPONSORSHIP OF ANY KIND NOW OR IN THE FUTURE. Must be able to pass a comprehensive background check, which includes a drug screen. We have industry-leading sterile injectable facilities providing solutions to take essential products from pre-clinical to the market. Pharmaceutical products come in many different dose forms including inhalations, oral dose, cream/ointment and injectables. Thank you for your interest as you consider starting a new career journey with us. As the world leader in serving science, our colleagues develop critical solutions through innovation—and build rewarding careers. Discover their extraordinary stories and connection to our Mission to enable our customers to make the world healthier, cleaner and safer. Their work is a story of purpose. What story will you tell? Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue of more than $40 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, increasing productivity in their laboratories, improving patient health through diagnostics or the development and manufacture of life-changing therapies, we are here to support them. Our global team 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, Patheon and PPD. 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. 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.

Requirements

High School Diploma or equivalent experience required.
Bachelor’s degree in Engineering or a Biological science-related field preferred.
Four years of relevant experience may substitute for a degree.
Proven work experience in the pharmaceutical or regulated industry preferred.
Capability to thrive in a fast-paced environment while managing multiple tasks effectively.
Outstanding time management and prioritization skills.
Outstanding interpersonal skills for maintaining effective working relationships, with highly effective verbal and written communication skills.

Responsibilities

Manage, lead, schedule, and complete multiple high-complexity projects with multidisciplinary departments to ensure flawless results.
Serve as the principal validation liaison, negotiating with clients on agreements and resolving significant validation, product, and regulatory issues.
Prepare, review, and approve production, validation, and audit reports, as well as master batch record documents, procedures, and rationales.
Evaluate new regulations and changes to existing ones, performing gap analysis to determine and address deficiencies.
Establish and implement systems to achieve process improvements and efficiencies.
Coordinate regulatory inspections performed by the FDA, MCA, and other agencies.
Defend policies, procedures, rationales, and methods during regulatory and client audits.
Establish and supervise quality programs and plans, such as validation, QAT, and supplier certification.