Engineer III, Validation

Regulatory Jobs; Greenville (NC); Presencial; USD 90.000 - 130.000; Jornada completa

Descripción de la vacante

Thermo Fisher Scientific in Greenville, NC is seeking a Validation Engineer to join the CQV team. You will support commissioning, qualification and validation across equipment, facilities and automation in a highly regulated environment.

You will collaborate with Engineering, Manufacturing, Quality, and Automation to ensure compliant, inspection-ready documentation and successful regulatory audits. A strong background in cGMP and technical writing is essential.

Formación

• Bachelor’s degree in Engineering, Life Sciences, Chemistry or a related technical field.
• Minimum of 5 years of relevant validation, CQV, engineering or closely related experience in pharmaceutical/biotech manufacturing or another highly regulated environment.
• Experience developing, reviewing and executing validation or qualification protocols, including IQ/OQ/PQ or equivalent lifecycle documentation.
• Experience with manufacturing equipment, facilities and utilities validation; experience with automation controls or computer system validation is valuable.
• Experience coordinating complex technical activities and working effectively across cross-functional teams.
• Equivalent combinations of education, training, and meaningful work experience may be considered

Responsabilidades

• Plan, author, review and execute commissioning, qualification and validation protocols and associated documentation for equipment, facilities, utilities, storage and manufacturing processes.
• Verify completion of validation activities associated with projects and quality-related work, ensuring documentation is accurate, complete and compliant with site procedures and cGMP expectations.
• Support qualification and verification of automation controls and computer-related systems associated with process equipment used in pharmaceutical manufacturing.
• Develop and apply risk assessments to determine validation strategy, testing scope and appropriate controls.
• Partner with Engineering, Manufacturing, Quality, Automation and other cross-functional groups to execute individual and team-based validation activities.
• Investigate issues, apply root cause analysis and support corrective actions and continuous improvement efforts.
• Provide technical support for project execution, equipment start-up and validation readiness, including potential Factory Acceptance Testing (FAT) activities.
• Maintain clear, inspection-ready technical documentation and support client or regulatory audit activities as needed.
• Build knowledge across aseptic processing, automated visual inspection (AVI), packaging and cold-storage operations, with exposure to equipment platforms such as Optima or IMA where applicable.

Conocimientos

Cross-functional collaboration

Technical writing

Problem solving

Project management

Regulatory compliance

Educación

Bachelor’s degree in Engineering, Life Sciences, Chemistry or related field

Descripción del empleo

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Cleanroom: no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair etc... allowed, Cold Room/Freezers -22degreesF/-6degrees C, 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.

Discover Impactful Work

Join our Validation Engineering team in Greenville, North Carolina, and help ensure reliable, compliant pharmaceutical manufacturing through commissioning, qualification and validation (CQV). In this role, you will support validation activities across the site for manufacturing equipment, facilities, utilities, storage, automation controls and related systems. You will work both independently and with cross-functional teams in an aseptic processing environment, applying sound engineering principles, risk-based thinking and procedural compliance to support safe, consistent operations.

This is an opportunity to broaden your technical experience across multiple areas of pharmaceutical manufacturing while contributing to site-wide process improvement. The team is highly collaborative, works hard, engages one another respectfully and operates as a unified group focused on improving site processes.

A Day in the Life

• Plan, author, review and execute commissioning, qualification and validation protocols and associated documentation for equipment, facilities, utilities, storage and manufacturing processes.
• Verify completion of validation activities associated with projects and quality-related work, ensuring documentation is accurate, complete and compliant with site procedures and cGMP expectations.
• Support qualification and verification of automation controls and computer-related systems associated with process equipment used in pharmaceutical manufacturing.
• Develop and apply risk assessments to determine validation strategy, testing scope and appropriate controls.
• Partner with Engineering, Manufacturing, Quality, Automation and other cross-functional groups to execute individual and team-based validation activities.
• Investigate issues, apply root cause analysis and support corrective actions and continuous improvement efforts.
• Provide technical support for project execution, equipment start-up and validation readiness, including potential Factory Acceptance Testing (FAT) activities.
• Maintain clear, inspection-ready technical documentation and support client or regulatory audit activities as needed.
• Build knowledge across aseptic processing, automated visual inspection (AVI), packaging and cold-storage operations, with exposure to equipment platforms such as Optima or IMA where applicable.

What to Expect

• Full-time, onsite role in Greenville, NC, generally Monday through Friday during normal business hours; scheduling can be flexible based on business needs and completion of responsibilities.
• Approximately three months of role-specific onboarding and training, followed by continued learning through hands-on project work and cross-functional exposure.
• Site-wide scope with opportunities to work across a technically diverse pharmaceutical manufacturing environment.
• Travel is expected to be less than 10% and may include FAT or other project-related activities.
• Work in controlled or cleanroom environments may be required based on assigned activities.

Education

• Bachelor’s degree in Engineering, Life Sciences, Chemistry or a related technical field.

Experience

• Minimum of 5 years of relevant validation, CQV, engineering or closely related experience in pharmaceutical/biotech manufacturing or another highly regulated environment.
• Demonstrated experience developing, reviewing and executing validation or qualification protocols, including IQ/OQ/PQ or equivalent lifecycle documentation.
• Experience with manufacturing equipment, facilities and utilities validation; experience with automation controls or computer system validation is valuable.
• Experience coordinating complex technical activities and working effectively across cross-functional teams.
• Equivalent combinations of education, training, and meaningful work experience may be considered

Knowledge, Skills and Abilities

• Working knowledge of cGMP requirements and regulated pharmaceutical manufacturing practices.
• Strong technical writing and documentation skills, with the ability to produce clear, accurate and inspection-ready records.
• Ability to apply engineering principles, risk assessment methodologies, problem-solving and root cause analysis to validation activities.
• Strong verbal and written communication skills and the ability to collaborate respectfully with technical and non-technical partners.
• Ability to manage priorities, work independently and contribute effectively in team-based project environments.
• Proficiency with Microsoft Office and relevant engineering/validation software tools.
• Experience with aseptic processing, automated visual inspection (AVI), packaging, cold storage, Optima or IMA equipment is preferred.
• Experience supporting regulatory inspections or client audits and familiarity with continuous improvement methodologies are preferred.
• Experience gained in other highly regulated technical environments may be considered when it demonstrates strong engineering principles and procedural compliance.

Competencies

• Accountable and self-directed
• Collaborative and respectful
• Quality and compliance focused
• Strong problem solver
• Effective communicator
• Eager to learn and broaden technical capability