Validation Engineer I

Purpose and Scope

The Validation Engineer I is responsible for supporting the planning, execution, and documentation of validation activities in a sterile injectable manufacturing environment. Responsibilities include equipment, facilities, utilities, cleaning and process validation in compliance with cGMP, FDA, EU, and other regulatory requirements.

Essential Duties & Responsibilities

• Assist in the development and execution of validation protocols (IQ/OQ/PQ) for equipment, facilities, utilities (e.g., CTUs, WFI, HVAC), and processes.
• Support cleaning and sterilization validation activities, including autoclaves, SIP systems, and aseptic processes.
• Participate in risk assessments (e.g., FMEA) and support change control evaluations.
• Collect and analyze validation data, prepare summary reports, and ensure documentation is accurate and audit-ready.
• Collaborate with cross-functional teams, including Quality Assurance, Manufacturing, Engineering, and Quality Control.
• 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. 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.

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

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: $73,000 - $83,000 annually
• 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.