Role Description The Validation CQV Engineer role is a contract, on-site position based in Springfield, NJ. In this role, the engineer will plan, execute, and document commissioning, qualification, and validation (CQV) activities for equipment, utilities, and processes within GMP-regulated environments. Daily responsibilities include developing and reviewing validation protocols and reports, performing system walkthroughs and testing, and ensuring alignment with regulatory and internal quality standards. The engineer will collaborate with cross-functional teams such as engineering, quality assurance, and operations to troubleshoot issues, support root cause investigations, and implement corrective and preventive actions. Additional tasks may involve maintaining validation documentation, supporting audits and inspections, and contributing to continuous improvement of validation practices and lifecycle management.
We are seeking an experienced Validation CQV Engineer to support commissioning, qualification, validation, and project activities within a pharmaceutical manufacturing environment. The successful candidate will work closely with Engineering, Manufacturing, Quality Assurance, Automation, Facilities, and external vendors to ensure equipment, systems, utilities, and processes are properly commissioned, qualified, and validated in compliance with applicable regulatory requirements and company procedures.
This position is ideal for a detail-oriented professional with strong knowledge of pharmaceutical validation practices, GMP requirements, and CQV documentation.
Key Responsibilities
- Develop and execute Commissioning, Qualification, and Validation (CQV) activities for pharmaceutical manufacturing facilities, equipment, utilities, and systems.
- Prepare, review, and execute validation documentation, including:
- User Requirements Specifications (URS)
- Functional/Design Specifications
- Risk Assessments
- Commissioning Test Plans
- FAT/SAT protocols
- Installation Qualification (IQ)
- Operational Qualification (OQ)
- Performance Qualification (PQ)
- Process and Cleaning Validation documentation
- Validation Summary Reports
- Support equipment and system commissioning activities from installation through qualification and turnover.
- Develop and execute test scripts and qualification protocols in accordance with approved procedures.
- Review engineering documentation, drawings, specifications, manuals, and vendor documentation.
- Coordinate with Engineering and vendors to resolve equipment and system deficiencies.
- Participate in Factory Acceptance Testing (FAT) and Site Acceptance Testing (SAT).
- Support deviation, discrepancy, investigation, and CAPA activities associated with CQV execution.
- Ensure validation activities are performed in accordance with cGMP, FDA, GxP, and applicable regulatory requirements.
- Review and approve validation documentation, as applicable.
- Participate in project meetings and provide CQV status updates, schedules, risks, and deliverables.
- Support change control activities related to validated systems and equipment.
- Work with Quality Assurance to ensure validation activities are completed in compliance with approved procedures.
- Assist with validation lifecycle management and periodic review activities.
- Support commissioning and qualification of systems such as:
- Temperature Mapping Equipment
- Incubators
- Refrigerators/ Freezers
- Cell cleaning and processing equipment
- Centrifuges
- Scales/ Balances
- Cell Counters
- Cryopods
- Controlled Rate Freezers
- Bio Safety Cabinets
- LN2 Freezers
- Cleanrooms
- Processing/ Manufacturing equipment
- Compressed gases
Qualifications
- Bachelor's degree in Engineering, Life Sciences, Pharmaceutical Sciences, Chemistry, or a related technical field.
- 2 or more years of experience in pharmaceutical, biotechnology, medical device, or other regulated manufacturing environments.
- Experience with Commissioning, Qualification & Validation (CQV) activities.
- Strong understanding of GMP/GxP requirements and FDA-regulated environments.
- Experience writing, executing, and reviewing validation protocols and reports.
- Experience with IQ/OQ/PQ and equipment/system qualification.
- Experience with FAT/SAT, commissioning, and equipment turnover.
- Strong technical writing and documentation skills.
- Ability to interpret engineering drawings, P&IDs, equipment specifications, and technical documentation.
- Strong problem-solving and troubleshooting skills.
- Ability to work independently while collaborating effectively with cross-functional teams.
- Excellent organizational and project-management skills.
- Strong attention to detail and ability to manage multiple priorities.
Required Experience
- Pharmaceutical or biopharmaceutical manufacturing experience.
- Hands-on experience with CQV/Validation execution.
- Experience working under cGMP/GxP requirements.
- Experience with validation documentation and electronic document management systems.
- Experience supporting deviations, change controls, investigations, and CAPAs.
- Experience working with Engineering, QA, Manufacturing, Automation, Facilities, and external contractors/vendors.
Preferred Qualifications
- Experience with new facility construction, facility expansion, or major capital projects.
- Knowledge of FDA, EMA, EU GMP, and ISPE guidelines.
- Experience with 21 CFR Part 11 and computerized system validation (CSV).
- Experience with clean utilities and process utilities.
- Experience with process, cleaning, and equipment validation.
- Familiarity with Quality Risk Management (QRM) principles.
- Experience with Veeva, ValGenesis, Maximo or similar systems.
Technical Skills
Candidates should have knowledge of:
- Commissioning & Qualification
- Equipment Qualification
- Facility Qualification
- Utility Qualification
- IQ/OQ/PQ
- FAT/SAT
- Process Validation
- Cleaning Validation
- Computerized System Validation
- GMP/GxP
- FDA regulations
- 21 CFR Part 11
- Risk Assessments
- Change Control
- Deviations & CAPA
- Data Integrity / ALCOA+
Pay: $40.00 - $65.00 per hour
Work Location: In person
