Senior Validaiton Engineer

Position Overview:

We are seeking a CQV Engineer with 7–11 years of experience supporting commissioning, qualification, and validation activities for GMP-regulated facilities, utilities, equipment, automation systems, and manufacturing processes. This role is responsible for the execution of commissioning and qualification activities, including system walkdowns, protocol execution, documentation review, discrepancy management, and system turnover support. The CQV Engineer will work cross-functionally with Engineering, Construction, Automation, Operations, Quality, and project teams to ensure systems are installed, tested, documented, and released in accordance with approved requirements, project timelines, and regulatory expectations.

Key Responsibilities:

• Review approved design, vendor, turnover, and qualification documentation in preparation for commissioning and qualification execution activities.
• Support system walkdowns, field verification activities, construction completion reviews, and readiness assessments.
• Execute commissioning and qualification protocols, including IQ, OQ, PQ, functional testing, and other approved test documentation as applicable.
• Verify installation of equipment, utilities, instrumentation, controls, and automation systems against approved drawings, specifications, vendor documentation, and design requirements.
• Verify system functionality, alarms, interlocks, controls, instrumentation, and operational requirements during execution activities.
• Coordinate testing activities with Engineering, Construction, Automation, Operations, Quality Assurance, and equipment vendors to support execution schedules.
• Perform and document field testing activities and collect objective evidence required to support protocol execution and qualification deliverables.
• Identify, document, and track discrepancies, punch-list items, protocol exceptions, and deviations encountered during execution activities.
• Support investigations, issue resolution, corrective actions, retesting, and closure of execution-related deviations and discrepancies.
• Perform protocol data review and ensure documentation is complete, accurate, attributable, and compliant with GMP documentation requirements.
• Review turnover packages and verify supporting documentation required for system acceptance and qualification.
• Develop and complete qualification summary reports, turnover documentation, and system closeout packages.
• Support system release and handover activities to Operations and Quality upon successful completion of required CQV deliverables.
• Maintain execution status and communicate progress, constraints, project risks, and dependencies to CQV and project leadership teams.
• Participate in project meetings and collaborate with cross-functional stakeholders to ensure alignment with project schedules and milestones.
• Support regulatory inspections, audits, and quality initiatives as they relate to commissioning, qualification, and validation activities.

Qualifications and Requirements

• Bachelor's degree in Engineering, Life Sciences, or a related technical discipline.
• 7–11 years of commissioning, qualification, validation, engineering, or related experience within the pharmaceutical, biotechnology, medical device, or other regulated life sciences industries.
• Strong understanding of FDA cGMP requirements, GDP documentation practices, and risk-based commissioning and qualification methodologies.
• Experience supporting commissioning and qualification activities for process equipment, clean utilities, facilities, automation systems, and manufacturing systems.
• Demonstrated experience executing and/or supporting IQ, OQ, PQ, commissioning, startup, and functional testing protocols.
• Experience reviewing engineering documentation, including P&IDs, specifications, equipment drawings, turnover packages, and vendor documentation.
• Familiarity with deviation management, discrepancy resolution, change control processes, and quality systems.
• Experience supporting startup, construction completion, system turnover, and operational readiness activities is preferred.
• Experience working in large capital project environments and collaborating with multidisciplinary project teams is preferred.
• Strong knowledge of commissioning, qualification, and validation principles within GMP-regulated environments.
• Ability to execute protocols in the field and effectively document testing results and objective evidence.
• Strong organizational skills with attention to detail and documentation accuracy.
• Excellent verbal and written communication skills with the ability to interact with stakeholders across multiple functional groups.
• Ability to manage multiple priorities and work effectively in a fast-paced project environment.
• Strong problem-solving skills and ability to support investigations, issue resolution, and risk mitigation activities.
• Ability to work independently while contributing effectively as part of a cross-functional project team.
• Proficient with Microsoft Office applications and electronic quality/documentation systems.