Talent.com
Validation Engineer III
Validation Engineer IIITolmar • Windsor, CO, United States
Validation Engineer III

Validation Engineer III

Tolmar • Windsor, CO, United States
job_description.job_card.variable_hours_ago
serp_jobs.job_preview.job_type
  • serp_jobs.job_card.full_time
job_description.job_card.job_description

Description

Core Hours

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

Purpose and Scope

The Validation Engineer III is responsible for leading validation strategy and execution across multiple systems and processes in a sterile injectable manufacturing environment. Responsibilities include ensuring compliance with cGMP, FDA, EU, and other regulatory requirements and providing technical leadership and mentorship to junior engineers.

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 and assist with commissioning activities, including, the development of requirements and specifications, risk assessments, acceptance and verification testing, and cycle development.
  • Lead cleaning validation 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.
  • Evaluate and implement new validation technologies and methodologies.
  • Provide validation guidance and support to teams in developing and executing protocols.
  • Lead 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.
  • Support internal and external audits and inspections.
  • 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

This position is expected to operate within the framework of Tolmar's 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.
  • Proven ability to lead medium to large validation projects.
  • Advanced technical writing and documentation skills.
  • Excellent oral and written communication skills.
  • Strong project management and cross-functional leadership skills.
  • Effective troubleshooting and problem-solving skills.
  • Knowledge of scientific and risk-based approaches aligned with industry best practices
  • Ability to maintain gowning requirements for controlled areas.
  • Ability to lead complex validation initiatives and mentor junior staff.
  • Ability to work both independently and as part of a team.
  • Ability to develop and implement creative solutions to problems.
  • Ability to train junior engineers in validation principles and philosophies

    • Education & Experience

  • Bachelor's or Master's degree in Engineering, Life Sciences, or a related technical field.
  • Minimum of 4 years' experience in validation, with demonstrated leadership in sterile pharmaceutical environments.
  • Expert knowledge of cGMP, FDA, EU, and ICH guidelines.
  • Experience with regulatory inspections and audit readiness.
  • Experience with aseptic processing, cleanroom classifications, and environmental monitoring.
  • Experience with validation software or electronic document management systems.

    • Working Conditions

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

    • Compensation and Benefits

  • Pay : $110,000 - $120,000 (depending on experience)
  • Benefits summary : https : / / www.tolmar.com / careers / employee-benefits

    • 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.

    serp_jobs.job_alerts.create_a_job

    Validation Engineer • Windsor, CO, United States