Validation Engineer II

Validation Engineer II

Job Category: Validation

Full-Time

On-site

Windsor CO, Windsor, CO 80550, USA

Description

Core Hours

Monday - Friday, 8:00 am - 5:00 pm

Purpose and Scope

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.

Essential Duties & Responsibilities

• 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.

Core Values

• Center on People: We commit to support the well-being of our patients. We are committed to treating our employees and those we serve as valued partners. By placing people at the heart of our actions, we actively engage, invigorate, acquire knowledge, and grow together.
• Are Proactive & Agile: We embody a culture of engagement and action. With a hands-on approach, we fearlessly adapt to change. We anticipate, respond swiftly and efficiently to ignite a spirit that propels us towards extraordinary outcomes.
• Act Ethically: We are committed to consistently conducting our business in an ethical, compliant, and socially aware manner, in line with our purpose of positively impacting lives. We actively cultivate diversity, equity, inclusion & sustainability in our workplace.
• Constantly Improve: We are committed to a collaborative & proactive effort to improve our products, systems, processes, and services by reducing waste, increasing efficiency & improving quality.
• Are Accountable: We think, act, and communicate with honesty, transparency, and clarity in alignment with our core values. We don't compromise our values for near term gain. We take accountability & ownership of our work, actions, successes, and setbacks. We strive to deliver our best as we shape the future.

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
• Bonus eligible
• Benefits summary:

Tolmar compensation programs are focused on equitable, fair pay practices including market-based base pay and a strong benefits package. The final compensation offered may vary from the posted range based on the selected candidates qualifications and 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.