Validation Engineer II

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

This position is expected to operate within the framework of Tolmar's Core Values :

Knowledge, Skills & Abilities

Education & Experience

Working Conditions

Compensation and 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.