QA Consultant

QA Consultant

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.

Automation QA Engineer

Location: Remote Employment Type: Contract / Consulting (6-12+ months) Start Date: ASAP

About the Role: We are seeking experienced Automation QA Engineers to support our clients in North Carolina. These roles will support automation quality assurance activities within a GMP-regulated pharmaceutical manufacturing environment, with a strong focus on commissioning, qualification, validation, and lifecycle documentation for automation systems. This is an excellent opportunity for candidates with pharmaceutical or biotech automation QA experience who are comfortable working cross-functionally with Validation, Engineering, Manufacturing, and Quality teams in support of large-scale capital and operational projects.

Key Responsibilities

• Provide QA oversight and support for automation-related qualification and validation activities
• Review and approve validation lifecycle documentation including:
• IQ/OQ/PQ protocols and reports
• Risk assessments
• Traceability matrices
• Change controls
• Deviations and CAPAs
• Support automation systems operating within GMP manufacturing environments
• Ensure compliance with FDA, cGMP, GAMP 5, and 21 CFR Part 11 requirements
• Partner with Automation, CQV, CSV, Manufacturing, and Quality teams to ensure compliant execution of project deliverables
• Participate in document reviews, project meetings, and quality assessments
• Support audit readiness and inspection preparedness activities
• Assist with implementation and continuous improvement of validation and QA processes

Preferred Systems / Technologies

Experience with one or more of the following is highly preferred:

• DeltaV
• Rockwell / PLC systems
• SCADA or HMI platforms
• MES systems (Syncade experience is a plus)
• Historian systems
• Automated manufacturing equipment within pharma/biotech environments

Qualifications

• Bachelor's degree in Engineering, Life Sciences, Computer Science, or related field preferred
• 3+ years of experience in Automation QA, CSV, CQV, or Validation within the pharmaceutical, biotech, or regulated manufacturing industry
• Strong understanding of GMP compliance and validation lifecycle principles
• Experience reviewing and approving GMP documentation
• Familiarity with data integrity and 21 CFR Part 11 requirements
• Excellent communication and cross-functional collaboration skills
• Ability to work independently in a remote environment

Why Join Valspec?

At Valspec, we offer more than just a job — we provide a career experience rooted in a standout culture, collaborative environment, and a strong sense of ownership. As an Employee Stock Ownership Plan (ESOP) company, every team member has a stake in our success, fostering a shared commitment to excellence and innovation. We also offer a highly competitive benefits package, including:

• Premium medical coverage
• 401(k) with company match
• Tuition reimbursement
• Unique performance incentives
• And more — all designed to support your growth, well-being, and future.

Join a team where your contributions matter, your development is prioritized, and your success is shared.