Validation Engineer II

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Loud Noises (Equipment/Machinery), Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.)

Job Description

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.

Key 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.
  
  

Qualifications:

• 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.