Manufacturing Validation Engineer III [Remote]

JOB DESCRIPTION

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.), Strong Odors (chemical, lubricants, biological products etc.)

Job Description

Location: Detroit, MI. Relocation assistance is NOT provided. 

*Must be legally authorized to work in the United States without sponsorship.

*Must be able to pass a comprehensive background check, which includes a drug screening.

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.

A Day in the Life:

• Lead complex validation projects for equipment, processes, expansion facilities, and computer systems.

• Create validation documentation IQ/OQ/PQ, establishing sampling plans and equivalency studies / strategies. 

• Leverage risk-based approach to develop validation plans

• Collaborate with cross-functional teams to maintain GMP standards.

• Contribute to continuous improvement initiatives, support team members, and provide technical expertise during client and regulatory audits.

• Ensure product quality and regulatory compliance across pharmaceutical manufacturing operations.

Minimum Requirements:

Education

• Minimum Required Education: Bachelor degree (Preferred Fields of Study: Engineering, Life Sciences, or related technical field)

Experience

• 3+ years of experience in validation in pharmaceutical/biotech manufacturing or comparable regulated industry

• Experience writing and executing validation protocols, including IQ/OQ/PQ documentation

• Experience leading complex validation projects and coordinating cross-functional teams

Knowledge, Skills, Abilities

• Proficiency with validation of manufacturing equipment, utilities, cleaning processes and computer systems

• Expertise in risk assessment methodologies and statistical analysis

• Strong technical writing and documentation skills

• Strong knowledge of cGMP regulations, including FDA, EMA and ISO requirements

• Advanced problem-solving abilities and root cause analysis experience

• Excellent verbal/written communication and interpersonal skills

• Proficiency with relevant software tools (MS Office, statistical packages, validation systems)

• Flexibility to work extended hours or alternate shifts based on project needs

• May require up to 25% travel

Physical Requirements / Work Environment

• Work requires standing for long durations, managing materials, and operating quality inspection instruments in a manufacturing setting.

Benefits

We offer competitive remuneration, annual incentive plan bonus, 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!

Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory at Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.

Apply today!