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Valvespace
Salary: 401(k) with compa
Role & seniority: Validation Engineer, mid-level (3+ years CSV experience)
Stack/tools: automated computer systems validation; SCADA/automation (Emerson DeltaV and/or Syncade preferred); MES and data integration; cGMP environment; GAMP5 and ASTM E2500 knowledge
Develop and execute qualification protocols and final summary reports
Generate quality assurance plans, verification/validation plans, and SOPs; conduct risk assessments
Participate in quality/regulatory audits and commissioning activities; support small projects or portions of larger projects
3+ years in Computer System Validation for process control/automation in biopharma
Experience with automation, commissioning, qualification, or operations in a cGMP setting
Direct experience developing and executing validation protocols; strong client-facing communication
Experience with Emerson DeltaV and/or Syncade; data integration systems
Familiarity with current industry standards (GAMP5, ASTM E2500)
Ability to work as part of a consulting engagement or long-term team member
Location & work type: Raleigh, NC; on-site role; eligible for long-term employment or consulting basis; must be legally eligible to work in the United States without sponsorship; ESOP company with competitive benefits.
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
Location: Raleigh, NC (AUTOMATION, INFORMATION & OPERATIONS TECHNOLOGY SOLUTIONS) VALSPEC is looking to identify top tier talent in the areas of automation and computer systems validation and system life cycle management. We are motivated to identify those that share our passion and can mirror the level of energy we put into ensuring that we remain on the cutting edge of the life sciences industry.
We are looking for tech savvy professionals with a proven track record in the SDLC (system development life cycle) of automated computer systems within biopharmaceutical environments. Due to our unique approach in meeting the demands of our customers, we are pursuing both individuals that can join our team long term as well as SMEs (subject matter experts) that would like to join us on a consulting basis. Overview This role supports the execution of small projects or portions of larger projects. Supports the generation of quality assurance plans, verification plans, validation plans, and standard operating procedures as well as conduct risks assessments and participate in Quality/Regulatory audits. Develops and executes qualification protocols and final summary reports and may participate in commissioning activities. Requirements 3+ years of Computer System Validation (CSV) experience with process control, SCADA and automation systems, MES and data integration systems (Emerson DeltaV and/or Syncade experience is highly preferred) Experience with automation, commissioning, qualification or operations in a cGMP environment. Direct experience developing validation protocols and execution of protocols. Knowledge of current industry standards such as GAMP5 and ASTM E2500. Tactical thinker with experience working with customers developing testing, validation and/or quality strategies. Excellent client communication skills. Why Join Valspec?