Manufacturing Validation Engineer III

Thermo Fisher Scientific • Detroit, MI

30d • Onsite

About The Position

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.

Requirements

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

Nice To Haves

• May require up to 25% travel

Responsibilities

• 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.

Benefits

• Relocation assistance is NOT provided.
• competitive remuneration
• annual incentive plan bonus
• healthcare
• a range of employee benefits
• outstanding career and development prospects
• an exciting company culture that stands for integrity, intensity, involvement, and innovation!

What This Job Offers

• Job Type: Full-time
• Career Level: Senior