Automation & IT CQV Senior Engineer

About the job: As an Automation & IT CQV Senior Engineer, you are responsible for planning, executing, and delivering commissioning, qualification, and validation (CQV) activities across pharmaceutical manufacturing systems and projects. You will work independently while coordinating with engineering, Automation & IT, Quality, project management, suppliers, customers, and other project stakeholders. Depending on project scope, you may also serve as a technical SME or lead defined project workstreams.

CQV Execution

• Plan, execute, and document Design Review/Qualification, IQ, OQ, PQ, and Process Validation activities based on project scope.
• Author and review validation plans, specifications, risk assessments, traceability matrices, protocols, reports, and other lifecycle documentation.
• Support commissioning and qualification readiness, including FAT activities and coordination across engineering, Automation & IT, Quality, suppliers, and operations.
• Investigate deviations and engineering changes, support Change Controls, and assess validation impacts.
• Create, revise, route, and maintain compliant electronic validation records in approved validation and quality systems.

Systems & Technical Expertise

• Support CQV activities across pharmaceutical manufacturing equipment, including aseptic formulation and filling, vision inspection, medical-device assembly, and packaging.
• Apply CQV expertise to automation and manufacturing IT systems such as DeltaV, Syncade, SCADA, PLC, and PAS-X.
• Support laboratories, facilities, and utilities, including instrumentation, monitoring and calibration, BMS, HVAC, refrigeration, and GMP utility systems.
• Support system modernization, lifecycle replacement, and electronic validation execution.

Systems & Technical Expertise

• Support CQV activities across pharmaceutical manufacturing equipment, including aseptic formulation and filling, vision inspection, medical-device assembly, and packaging.
• Apply CQV expertise to automation and manufacturing IT systems such as DeltaV, Syncade, SCADA, PLC, and PAS-X.
• Support laboratories, facilities, and utilities, including instrumentation, monitoring and calibration, BMS, HVAC, refrigeration, and GMP utility systems.
• Support system modernization, lifecycle replacement, and electronic validation execution.

Project, Client & Team Support

• Coordinate CQV deliverables and communicate project status, risks, constraints, and escalations.
• Collaborate across technical disciplines and with customers, suppliers, Quality, and project stakeholders.
• Serve as a technical SME or lead defined CQV workstreams based on project needs.
• Review work and coach junior colleagues while promoting quality, compliance, and best practices.
• Contribute technical expertise to continuous improvement and development of customer solutions.

The Senior Automation & IT profile specifically supports independent delivery, reviewing and coaching junior colleagues, SME-level knowledge, customer engagement, and the ability to assume Project SME or Project Lead responsibilities.

Qualifications: You bring strong CQV expertise combined with a practical, hands-on approach to project delivery. You are comfortable working independently in a project-based environment, taking ownership of your work, navigating changing priorities, and collaborating across engineering, Automation & IT, Quality, suppliers, and customers. You communicate clearly, raise risks early, and use your technical expertise to solve problems and support others., * Bachelor’s or Master’s degree in Engineering, Automation, Computer Science, Life Sciences, or a related discipline, or equivalent relevant experience.

• 5+ years of commissioning, qualification, or validation experience within pharmaceutical, biotechnology, medical-device, or other regulated manufacturing.
• Strong knowledge of GMP and risk-based validation, with familiarity with FDA expectations, EU Annex 15, GAMP 5, and applicable company procedures.
• Experience independently authoring, reviewing, and executing clear, traceable validation documentation.
• Experience with pharmaceutical manufacturing equipment, automation/manufacturing IT, laboratories, facilities, or utilities.
• Strong communication, practical problem-solving, and cross-functional collaboration skills.
• Ability to work independently, manage complex priorities, make decisions under uncertainty, and raise risks early.
• Preferred Qualifications
• Experience with DeltaV, Syncade, SCADA, PLC, PAS-X, BMS, or similar pharmaceutical automation and manufacturing systems.
• Experience with electronic validation and quality systems such as TIMS (HP ALM) and Veeva QualityDocs/Vault Quality.
• Experience supporting FAT, system modernization, lifecycle replacement, or larger capital projects.
• Experience serving as a technical SME or leading defined CQV workstreams., This position is not eligible for employer-sponsored work authorization. Candidates must have unrestricted authorization to work in the United States and must not require current or future sponsorship to maintain that authorization..

• Competitive salary with annual adjustment increases
• 160 hours of PTO (prorated from hire date) + 14 paid holidays
• Health, dental, and vision insurance from day one
• 8% guaranteed 401(k) company contribution
• 14 weeks paid parental leave
• Company-paid life and disability insurance
• Employee referral bonuses