Engineer II, Validation
Engineer II, Validation
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Salary Not Disclosed
1 Vacancy
Job Description
Work Schedule
Standard Office Hours (40/wk)Environmental Conditions
Adherence to all Good Manufacturing Practices (GMP) Safety Standards OfficeJob Description
Title: Engineer II Validation
As part of the Thermo Fisher Scientific team youll 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 worlds 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 youll 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.
Bachelors 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.
Employment Type
Full-Time
