Validation Engineer II

Tolmar; Windsor (CO); On-site; USD 90,000 - 100,000; Full time

Job summary

Tolmar is seeking a Validation Engineer II in Windsor, CO to independently plan, execute, and document validation activities in a sterile injectable manufacturing environment.

You will coordinate cross‑functional validation plans, protocols, and reports, and lead IQ/OQ/PQ validation for equipment, facilities, utilities, and processes while supporting continuous improvement and regulatory readiness.

Qualifications

• Bachelor’s degree in Engineering, Life Sciences, or related field.
• Minimum of 2 years’ validation experience, preferably in sterile pharma/biotech.
• Strong understanding of cGMP, FDA and EU regulatory requirements.
• Familiarity with aseptic processing, cleanrooms and environmental monitoring preferred.
• Experience with validation software or electronic document management systems preferred.

Responsibilities

• Plan and coordinate validation activities for cross‑functional projects (plans, protocols, reports).
• Develop and execute validation protocols (IQ/OQ/PQ) for equipment, facilities, utilities, and processes.
• Lead cleaning and sterilization validation activities (autoclaves, SIP).
• Conduct risk assessments (FMEA) and support change control evaluations.
• Analyze validation data, prepare reports, ensure audit readiness.
• Collaborate with QA, Manufacturing, Engineering, and QC.
• Maintain validation lifecycle documentation per internal procedures.

Skills

GMP knowledge

Technical writing

Project management

Communication

Problem solving

Education

Bachelor’s degree in Engineering or Life Sciences

2+ years validation experience

Sterile pharma/biotech exposure preferred

Regulatory knowledge (FDA/EU)

Tools

Validation software

Electronic Document Management Systems

Microsoft Office

Job description

Windsor CO
9351 Eastman Park Drive
Windsor, CO 80550, USA

The Validation Engineer II is responsible for independently planning, executing, and documenting validation activities in a sterile injectable manufacturing environment. Responsibilities include equipment, facilities, utilities, cleaning and process validation, all in compliance with cGMP, FDA, EU, and other regulatory requirements.

• Plan and coordinate validation activities for cross‑functional projects, including but not limited to validation plans, protocols, and reports
• Develop and execute validation protocols (IQ/OQ/PQ) for equipment, facilities, utilities, and processes.
• Lead cleaning and sterilization validation activities, including autoclaves and SIP systems.
• Conduct risk assessments (e.g., FMEA) and support change control evaluations.
• Analyze validation data, prepare comprehensive reports, and ensure audit readiness.
• Collaborate with cross‑functional teams, including QA, Manufacturing, Engineering, and Quality Control.
• Maintain validation lifecycle documentation in accordance with internal procedures and regulatory expectations.
• Provide validation guidance and support to teams in developing and executing protocols.
• Support investigations and CAPAs related to validation deviations or failures.
• Contribute to continuous improvement initiatives in validation practices.
• Stay current with industry trends, regulatory updates, and best practices in validation and sterility assurance.
• Participate in required annual hazardous waste training. Hazardous waste involvement may include, but is not limited to container and tank management and inspections, generation of hazardous waste as a part of production or sampling processes and transfer of hazardous waste between lab procedure area, satellite accumulation and storage. Respond to spills per the Chemical Spill Procedures.
• Perform other related duties as assigned.

Knowledge, Skills & Abilities

• Proficient in Microsoft Office Suite.
• Knowledge of GMP regulations and validation guidelines.
• Strong technical writing and documentation skills.
• Excellent oral and written communication skills.
• Effective organizational and project management skills.
• Effective troubleshooting and problem‑solving skills.
• Ability to maintain gowning requirements for controlled areas.
• Ability to manage multiple projects simultaneously.
• Ability to work both independently and as part of a team.
• Ability to develop and implement creative solutions to problems.

Education & Experience

• Bachelor’s degree in Engineering, Life Sciences, or a related technical field.
• Minimum of 2 years’ experience in validation, preferably in a sterile pharmaceutical or biotech environment.
• Strong understanding of cGMP, FDA, and EU regulatory requirements
• Familiarity with aseptic processing, cleanroom classifications, and environmental monitoring preferred.
• Experience with validation software or electronic document management systems preferred.

Working Conditions

• Working conditions include general office environment, laboratory and manufacturing setting (clean rooms where gowning is required)
• Business demands may require working extended hours

Compensation and Benefits

• Pay: $90,000 to $100,000 per year depending on experience

Tolmar is an Equal Opportunity Employer. We do not discriminate on the basis age 40 and over, color, disability, gender identity, genetic information, military or veteran status, national origin, race, religion, sex, sexual orientation or any other applicable status protected by state or local law. It is our intention that all qualified applicants be given equal opportunity and that selection decisions are based on job‑related factors.

Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities. This employer is required to notify all applicants of their rights pursuant to federal employment laws. For further information, please review the Know Your Rights notice from the Department of Labor.