What are the responsibilities and job description for the Packaging Equipment Validation Lead position at Pinnaql?
Pinnaql is a trusted consulting partner to regulated life sciences companies, providing deep technical, validation, and quality expertise across every stage of the product lifecycle. We partner with pharmaceutical, biotech, and medical device organizations to navigate complexity, accelerate project timelines, and maintain a strong state of compliance and audit readiness.
Validation and Engineering Group, a Pinnaql company, is seeking a Packaging Equipment Validation Lead with strong leadership and communication skills to lead packaging qualification and validation efforts for sterile liquid filling and packaging operations in Greenville, SC. This is a 12 month contract position with the potential for extension based on project needs and performance.
Position Overview
The selected professional will coordinate and execute all CQV activities related to a new packaging line handling liquid products in multiple bottle and cap configurations. This role works closely with client engineering, manufacturing, and quality teams to ensure project success and regulatory compliance.
Responsibilities
- Lead the packaging validation project, coordinating cross-functional efforts and ensuring alignment with project objectives, timelines, and regulatory requirements.
- Develop and execute validation documentation (URS, risk assessments, FAT/SAT, IQ/OQ/PQ, and final reports) for packaging lines and related equipment, including fillers, cappers, labelers, conveyors, vision inspection, and serialization systems.
- Manage communication between validation, engineering, and quality teams to drive efficient decision-making and issue resolution.
- Oversee qualification of change parts, line configuration changes, and multiple bottle/cap presentations.
- Provide hands-on support during commissioning and execution phases, including troubleshooting and deviation resolution.
- Support process performance qualification (PPQ) activities and readiness for commercial production.
- Ensure all validation deliverables comply with cGMP, FDA, and EU Annex 1 requirements, as well as internal procedures and the site's Validation Master Plan (VMP).
Qualifications
- Bachelor’s degree in Engineering or Natural Sciences.
- 3 years of experience in packaging validation for sterile or aseptic liquid operations.
- Demonstrated experience leading validation projects or small technical teams.
- Solid understanding of liquid filling systems, packaging automation, inspection technologies, and capping mechanisms.
- Strong knowledge of GAMP 5, 21 CFR Part 11, and Annex 1.
- Excellent communication, organization, and documentation skills, with the ability to effectively interact with clients, peers, and management.
- Ability to work independently and manage multiple priorities in a fast-paced, regulated environment.
- Candidates must be authorized to work for any employer in the United States without visa sponsorship.
Preferred Skills
- Experience leading packaging validation for sterile liquids or biologics.
- Familiarity with serialization and aggregation systems.
- Previous client-facing or project leadership experience within pharmaceutical or biotechnology manufacturing.
At Pinnaql, 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 your opportunity to make a meaningful difference. You’ll help shape the future of healthcare and technology, working alongside a purpose-driven team that’s as ambitious as it is supportive.
Excited to build something meaningful together? We look forward to hearing from you!
Pinnaql 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.
