Valspec—a global provider of system validation and lifecycle services—provides commissioning and qualification of computerized systems for clients in the Life Sciences industry. Established in 1999, Valspec's mission is to provide a wide spectrum of services that help its clients meet their capital project and lifecycle maintenance goals.

Valspec's projects are critical to the industry, and to the people who rely on its products. Many projects ensure that life-changing drugs are available to those who need them; others streamline production to meet demand at a lower cost, allowing for the discovery of new and innovative therapies.

Validation Engineer – BMRAM System

Life Sciences Manufacturing Company

Position Overview

We are seeking a skilled Validation Engineer to join our team and lead the validation efforts for the Blue Mountain Regulatory Asset Manager (BMRAM) system within a dynamic life sciences manufacturing environment. This role requires expertise in validation processes, regulatory compliance, and asset management systems, ensuring that the BMRAM system operates effectively and adheres to industry standards.

Responsibilities

• Develop and execute validation protocols (IQ/OQ/PQ) for the Blue Mountain Regulatory Asset Manager (BMRAM) system.
• Collaborate with cross-functional teams to gather requirements for system configuration and validation.
• Perform risk assessments to identify critical aspects of the system and ensure compliance with GxP and FDA regulations.
• Document all validation activities, including protocols, test scripts, reports, and traceability matrices.
• Maintain the validated state of the BMRAM system by conducting periodic reviews and revalidation as required.
• Support audits and inspections, providing detailed validation documentation and responding to inquiries.
• Ensure the system meets operational, compliance, and security requirements.
• Assist in training end-users and provide technical support during system implementation and operation.
  
  

Qualifications

• Bachelor's degree in Engineering, Computer Science, Life Sciences, or a related field.
• Minimum 3-5 years of experience in validation engineering within the life sciences or pharmaceutical industry.
• Strong knowledge of GxP regulations, including FDA 21 CFR Part 11 and EU GMP Annex 11.
• Experience with computerized systems validation (CSV) and asset management systems.
• Excellent technical writing skills to produce high-quality validation documentation.
• Problem-solving skills with a meticulous attention to detail.
• Strong interpersonal and communication skills to work effectively with diverse teams.
• Project management experience is a plus.
  
  

Why Join Us?

• Work on cutting-edge systems in a high-impact industry that improves lives worldwide.
• Collaborate with a team of dedicated professionals in a supportive and innovative environment.
• Receive opportunities for continuing education, career growth, and professional development.
  
  

How to Apply

If you are passionate about validation engineering and want to contribute to advancing life sciences manufacturing, we encourage you to apply.

Valspec offers a standout culture, fantastic work environment, and has very competitive benefits to include premium medical, 401K match, tuition reimbursement, and other unique incentives.

Candidates must be legally eligible to work in the United States without company sponsorship. Also, we are not interested in working on a corp-to-corp basis with other companies at this time.

Any third-party unsolicited resume submission(s) will immediately become the property of Valspec. Valspec will not pay any fee to a submitting employment agency, person, or entity unless a signed agreement is established.

Valspec is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to sex, race, color, religion, national origin, age, sexual orientation, gender identity, disability, protected veteran status or any other protected class. We are committed to providing a professional environment free of any discrimination or harassment, and we are proud to be a Drug-Free Workplace.