Work Schedule

Standard (Mon-Fri)

Environmental Conditions

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

Job Description

Title: Engineer III, 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 III, Validation, you will provide direct quality support through compliance, regulatory assessment, and validation activities. You will lead and guide lower-level staff, ensuring accurate and timely completion of quality functions. This position involves frequent decision-making, coordination, and communication with various collaborators. You will build, review, approve, track, and present documents and procedures required for pharmaceutical regulations' compliance.

A Day in the Life:

Prepare, review, and approve production, validation, audit reports, master batch record documents, procedures, and rationales.

Establish systems to ensure compliance with new and changing regulations and conduct quality systems training across the company.

Identifying areas of non-compliance and implementing solutions to resolve major quality and efficiency issues will be key responsibilities.

Manage, lead, schedule, complete, and supervise multiple high-complexity projects with multi-disciplinary departments to ensure accurate completion of work.

Serve as the principal validation liaison for negotiating with clients on agreements/projects and resolving significant validation, product, and regulatory issues.

Evaluate new regulations, changes to existing regulations, and regulatory trends; perform gap analysis to resolve deficiencies and take appropriate actions.

Establish actions and implement systems to achieve process improvements and efficiencies to address shortcomings in processes and systems.

Host and coordinate regulatory inspections performed by the FDA, MCA, and other regulatory agencies.

Defend policies, procedures, rationales, and methods in the area(s) of expertise during regulatory and client audits.

Establish and supervise quality programs and plans (e.g., validation, QAT, supplier certification).

Identify training needs and develop training programs.

Work in a safe and responsible manner to build an injury-free and incident-free workplace. Align with all job-related safety and other training requirements.

Perform other duties as assigned.

Keys to Success:

Education

Bachelor’s degree in Engineering, or a Biological Science, or a related field required.

Experience

4 years in the pharmaceutical industry or a regulated industry is preferred.

2 years of validation experience in a regulated industry is required.

Knowledge, Skills, Abilities

Proficient in the use of computerized office applications (e.g., Word, Excel, Outlook) and systems/business applications.

Demonstrated scientific writing skills and knowledge of cGMPs and FDA/industry expectations.

Ability to achieve goals and resolve sophisticated technical problems.

Ability to empower, energize, and retain key staff through direct interactions.

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

Ability to work in a fast-paced environment, balance multiple tasks, and maintain confidentiality.

Highly effective verbal and written communication skills and interpersonal skills to establish and maintain effective working relationships.

Physical Requirements/Work Environment

Ability to move about office locations, stand, walk, stoop, kneel, crouch, manipulate light to medium weights, and perform tasks requiring dexterity and visual acuity for prolonged periods.

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.