Sr. CQV Project Manager
Job Description
Job Description
Validation & Engineering Group, Inc. (V&EG) a Pinnaql company is a leading services supplier who provides solutions for the Pharmaceutical, Biotechnology, Chemical, Food, and Medical Devices industries in the following areas: Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services.
We are seeking a talented, dedicated individual committed to work under the highest ethics standards for the following position:
- Sr. CQV Project Manager
Description:
The Senior Commissioning, Qualification & Validation (CQV) Project Manager is responsible for leading CQV activities across pharmaceutical manufacturing and/or biologics facilities. This role oversees planning, execution, and delivery of CQV projects in compliance with regulatory requirements, ensuring systems, utilities, equipment, and processes are fit for intended use.
The position requires strong leadership, technical expertise in CQV lifecycle management, and the ability to coordinate cross-functional teams in a regulated GMP environment.
Key Responsibilities
- Lead and manage CQV project execution from planning through final approval and turnover.
- Develop and maintain CQV strategies, validation master plans (VMPs), and execution schedules.
- Oversee commissioning and qualification of facilities, utilities, equipment, and computerized systems.
- Ensure compliance with cGMP, FDA, EU Annex 15, and applicable regulatory guidelines.
- Coordinate multidisciplinary teams including engineering, quality assurance, manufacturing, and validation.
- Review and approve validation protocols (IQ/OQ/PQ) and ensure timely execution.
- Manage project timelines, budgets, resources, and risk assessments.
- Drive deviation management, change control, and CAPA activities related to CQV deliverables.
- Interface with stakeholders to ensure alignment on project scope and deliverables.
- Support regulatory inspections and audits as CQV subject matter expert.
- Ensure proper documentation practices and data integrity compliance.
Required Qualifications
- Bachelor’s degree in Engineering, Life Sciences, or related field (Master’s preferred).
- 10+ years of experience in pharmaceutical or biotech industries.
- Strong background in CQV, validation, or manufacturing engineering.
- Proven experience managing CQV projects in GMP-regulated environments.
- Knowledge of regulatory requirements (FDA, EMA, ISPE guidelines).
- Experience with validation lifecycle for equipment, utilities, and systems.
- Strong leadership, organizational, and stakeholder management skills.
- Ability to work in a fast-paced, project-driven environment.
- Preferred Skills
- Experience in biologics or sterile manufacturing environments.
- Knowledge of automation systems (DeltaV, PLCs, SCADA) and CSV.
- PMP certification or similar project management credential.
- Experience supporting greenfield or large-scale expansion projects.
- Strong communication skills in both English and Spanish (preferred for Puerto Rico sites).
- Available to work extended hours, possibility of weekends and holidays.
At Validation & Engineering Group, people always come first. We believe that when you're empowered to do your best work, bold ideas thrive and real progress happens. This isn't just a job - it's an opportunity to make a meaningful difference by shaping the future of healthcare and technology alongside a purpose-driven, supportive team.
Excited to build something meaningful together? We look forward to hearing from you.
Validation & Engineering Group is an equal opportunity employer. All applicants will be considered for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran status, or disability status.