Validation Engineer III

Core Hours

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

Purpose and Scope

Responsible for leading the development and execution of commissioning, qualification, and validation (CQV) activities related to the support of facilities, utilities, systems, and equipment (FUSE). This position may also be responsible for development and validation of processes such as cleaning validation, aseptic process simulation, and environmental monitoring.

Essential Duties & Responsibilities

• Support change management of new and existing systems through impact assessments.
• Participate in investigations related to quality systems and processes.
• Continuous development of CQV program to ensure alignment with current risk-based based guidance and regulations.
• Follow and maintain Validation periodic review and re-qualification schedules and activities.
• Plan and coordinate CQV activities for cross-functional projects, including, but not limited to plans, protocols, and reports.
• Support internal and external audits and inspections.
• Assist commissioning activities, including, but not limited to, the development of requirements and specifications, risk assessments, acceptance and verification testing, and cycle development.

• 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.

Knowledge, Skills & Abilities 

• Advanced organization and project management skills. 
• Advanced troubleshooting and problem-solving skills.
• Proven skills in leading medium to large validation projects.
• Ability to maintain gowning requirements as needed to access controlled areas.
• Ability to lead multiple projects simultaneously.
• Ability to work both independently and in conjunction with a team.
• Develop and implement creative solutions to problems.
• Proficient knowledge with MS Office.
• Proficient knowledge of GMP regulations and validation guidelines, including 21 CFR Part 11.  

• Knowledge of science and risk-based approaches aligned with industry best practices.
• Proficient (Subject Matter Expert) in two or more validation processes.
• Proficient knowledge and experience in writing protocols and following procedures.
• Experienced with validation tools such as Ellab.  
• Excellent oral and written communication skills.
• Ability to train junior associates in validation principles and philosophies.

Core Values

• The Validation Engineer III 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.​

Education & Experience

• Bachelor’s degree in engineering/science related field Required.
• A minimum of 5 years of experience in the pharmaceutical industry with a minimum of 3 years of Validation experience.
• In depth knowledge of current validation principles, standard concepts, practices, procedures and requirements in GMP regulated environments

• Experience in Statistical Analysis a plus.

Working Conditions

• Working conditions are normal for an office environment.
• Work may require occasional weekend and/or evening work.
• Work inside manufacturing clean rooms where gowning is required.

Compensation and Benefits

• Pay: $100,000 - $110,000 depending on experience
• Bonus eligible
• 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.

Salary : $100,000 - $110,000