Senior Validation Engineer - Csv (Hybrid-Remote)

Purpose and Scope

Responsible for the development and execution of Validation activities including, but not limited to, design, commissioning and qualification of computer and software systems, and automated equipment and systems for use within GMP areas. In addition, this role will be responsible for management of the Computer Systems Validation (CSV) program within Tolmar facilities.

Essential Duties & Responsibilities

• Assist in development and management of the CSV program, including integration of automated equipment and instruments, status log, and periodic review schedule, ensuring alignment with current practice, industry guidelines and regulatory requirements.
• Generation of specifications, protocols, plans, reports, and other applicable documentation required for the complete computer system lifecycle.
• Responsible for assessing impact to the validated status and/or product quality, and identify appropriate actions based on risk as part of change controls, investigations, and CAPAs.
• Working within cross-functional teams to ensure project compliance to CSV/CSA philosophy.
• Provide mentorship and guidance on validation philosophy and strategy to junior engineers.
• Manage, schedule, and coordinate validation activities with cross-functional teams.
• Represent the Validation Department as the CSV/CSA Subject Matter Expert (SME) during internal and regulatory audits.
• Promote collaboration between IT, Data Integrity, Automation, Quality Assurance, and system owners to ensure all required prerequisites are appropriately developed to support validation activities and deliverables.
• Participate and lead Lean transformation projects.
• Additional related responsibilities as assigned by management.

Knowledge, Skills & Abilities 

• Experience working with MS Office, and various GMPS systems such as Veeva eQMS, Maximo CMMS, BMS, LIMS, and ERPs.
• Excellent organization and project management skills, for successful execution of multiple projects simultaneously.
• Experience in investigation and root cause analysis techniques.
• Ability to work both independently and within cross-functional teams.
• Proficient knowledge of CSV/CSA principles, industry guidance, and regulatory requirements.
• Exceptional oral and written communication skills for well-written justifications, interaction with senior leadership, and both internal and external vendors or customers.

Core Values

• The Senior Validation Engineer is expected to operate within the framework of Tolmar’s Core Values:
  • Consistently operate with the highest standards of ethics and compliance.
  • Take ownership of your actions, success and setbacks.
  • Respect each other and understand that honest collaboration is at the heart of our company success.
  • Go the extra mile to make things happen.
  • Be committed to all we do and the patients we serve.
  • Embrace change with enthusiasm.
  • Strive to learn about and understand the needs of customers and patients, and take action with great speed and efficiency no matter the task.

 Education& Experience

• Bachelor’s degree in Computer Science or Engineering field, preferred.
• A minimum of eight (8) years within pharmaceutical, biotech, or medical device manufacturing, with a minimum of five (5) years direct involvement in qualification and validation of computer systems and/or automation.
• Experience in Statistical Analysis desired, JMP software preferred.

Compensation and Benefits

• Annual pay range $115,000 - $125,000
• Bonus eligible
• Relocation benefits available
• Benefits information: 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. 

Working Conditions

• Working conditions are normal for an office environment. Require onsite visits every other month on average. 
• Work may require occasional weekend and/or evening work.
• Work may include environments inside manufacturing clean rooms where gowning is required.

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.