QA Validation Specialist

Pinnaql Inc.

Sanford, Florida, United States

Sanford, Florida, United States

Über

QA Validation Specialist Description The QA Validation Specialist serves as a dedicated member of the QA Validation organization, supporting equipment qualification and lifecycle management activities within a regulated pharmaceutical manufacturing environment. This role works closely with Quality Control, Engineering, Technical Services, Operations, and cross‑functional teams to ensure compliance with cGMP requirements while supporting qualification, validation, and equipment lifecycle initiatives.
The ideal candidate possesses strong technical expertise in equipment qualification from a Quality Assurance perspective, combined with excellent communication, collaboration, and problem‑solving skills.
Responsibilities
Represent Quality Assurance in equipment qualification and validation activities.
Review and approve qualification and validation documentation, including:
IQ/OQ Protocols and Reports
SARRs
URSs
Qualification Plans
Lifecycle Documentation
Associated Validation Deliverables
Provide QA oversight throughout the equipment lifecycle, including:
Qualification
Enrollment
Change Management
Decommissioning
Periodic Review Activities
Support Computer System Validation (CSV) activities associated with equipment and laboratory systems.
Participate in cross‑functional meetings and project teams involving QA, QC, Engineering, Technical Services, and Operations.
Support equipment qualification projects and ensure compliance with procedures and regulatory requirements.
Review and approve deviations, investigations, root cause analyses, CAPAs, and effectiveness checks as required.
Provide QA support for technical assessments, triage meetings, robustness initiatives, and project‑related activities.
Escalate quality and compliance concerns appropriately and in a timely manner.
Contribute to project planning, execution, and continuous improvement initiatives.
Qualifications
Bachelor’s Degree in Engineering, Life Sciences, Chemistry, Microbiology, Pharmacy, or related technical discipline.
Minimum 5 years of experience in pharmaceutical, biotechnology, or regulated manufacturing environments.
Strong experience supporting equipment qualification from a Quality Assurance perspective.
Hands‑on experience with:
IQ/OQ/PQ
Equipment Lifecycle Management
SARR
URS Development and Review
Equipment Enrollment
Equipment Decommissioning
Change Control
Computer System Validation (CSV)
Strong understanding of cGMP regulations and quality systems.
Experience reviewing and approving validation documentation and quality records.
Experience with:
Veeva Vault
Kneat (EDES)
EAMS
TrackWise or similar Quality Management Systems
Knowledge of FDA, EMA, and global regulatory expectations related to validation and qualification.
Strong interpersonal and communication skills.
Ability to work effectively in cross‑functional teams.
Strong organizational and time‑management skills.
Ability to manage multiple priorities in a fast‑paced environment.
Strong analytical, investigation, and problem‑solving abilities.
Flexibility, adaptability, and a collaborative mindset.
Technical Writing skills and investigations processes.
Available to work extended hours, possibility of weekends and holidays.
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.
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Sanford, Florida, United States

Sprachkenntnisse

English

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