Validation Engineer I

Tolmar•Windsor, CO

4h•$73,000 - $83,000

About The Position

The Validation Engineer I supports the planning, execution, and documentation of validation activities in a sterile injectable manufacturing environment. The role covers equipment, facilities, utilities, cleaning, sterilization, and process validation in compliance with cGMP, FDA, EU, and other regulatory requirements. The position works with cross-functional teams and maintains accurate, audit-ready validation lifecycle documentation. The role also operates within Tolmar’s Core Values, including a commitment to people, adaptability, ethical conduct, continuous improvement, and accountability.

Requirements

Bachelor’s degree in Engineering, Life Sciences, or a related technical field.
Some experience in validation.
Proficiency 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 independently and as part of a team.
Ability to develop and implement creative solutions to problems.

Nice To Haves

Validation experience in a sterile pharmaceutical or biotech environment.
Understanding of GMP, FDA, and EU regulatory requirements.
Experience qualifying CTUs and using Ellab temperature mapping systems.

Responsibilities

Assist in developing and executing IQ/OQ/PQ validation protocols for equipment, facilities, utilities such as CTUs, WFI, and HVAC, and processes.
Support cleaning and sterilization validation activities, including autoclaves, SIP systems, and aseptic processes.
Participate in risk assessments such as FMEA and support change control evaluations.
Collect and analyze validation data, prepare summary reports, and ensure documentation is accurate and audit-ready.
Collaborate with Quality Assurance, Manufacturing, Engineering, and Quality Control teams.
Maintain validation lifecycle documentation in accordance with internal procedures and regulatory expectations.
Support investigations and CAPAs related to validation deviations or failures.
Stay current with industry trends, regulatory updates, and best practices in validation and sterility assurance.
Participate in required annual hazardous waste training and related hazardous waste handling, management, inspections, and spill response as applicable.
Perform other related duties as assigned.