Work Schedule

Standard Office Hours (40/wk)

Environmental Conditions

Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Office

Job Description

Title: Engineer II, Validation

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.

Division/Site Specific Information

Position will support to the Greenville, NC, site and will report to the Sr Manager,

Validation. The Drug Product Division - North America (DPD-NA) is one of the five divisions that make up the Pharma Services Group. We are made up of approximately 4400 colleagues across six sites who specialize in taking sterile injectable and oral solid dose drug products from development to commercialization.

Discover Impactful Work:

As an Engineer II in Validation at Thermo Fisher Scientific, you'll contribute to impactful global health projects. 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.

A Day in the Life:

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.

Keys to Success: Education

High School Diploma or equivalent required.

Bachelor’s degree in Engineering or a Biological science-related field highly preferred.

Experience

Four years of relevant experience in lieu of a BS degree, or with degree no experience will be required.

Knowledge, Skills, Abilities

Proven work experience in the pharmaceutical or regulated industry preferred.

Capability to thrive in a fast-paced environment while managing multiple tasks effectively.

Outstanding attention to detail, interpersonal skills, and effective time management.

Outstanding time management and prioritization skills.

Outstanding interpersonal skills for maintaining effective working relationships, with highly effective verbal and written communication skills.

Benefits

We offer competitive remuneration, annual incentive plan bonus scheme, healthcare, and a range of employee benefits! Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization, and outstanding career and development prospects. We offer an exciting company culture that stands for integrity, intensity, involvement, and innovation.