Overview
Principal Quality Auditor Jobs in Greenville, SC at Bausch + Lomb
Job Title: Equipment Validation Specialist (Levels III & IV)
Location: Portsmouth, NH (onsite)
Employment Type: Contract
Duration: 9+ months
Job Description:
The Equipment Validation Specialist will play a critical role in ensuring that all GMP (Good Manufacturing Practice) equipment and systems are validated and maintained in accordance with user requirements, process parameters, and global regulatory guidelines. This position will involve working closely with Operations, Quality Assurance, and Regulatory bodies to provide scientifically sound, documented evidence demonstrating that systems and processes perform as required, ensuring the delivery of a compliant and high-quality manufacturing environment.
Key Responsibilities:
Validation of GMP Equipment & Systems: Perform validation activities for all critical GMP equipment and systems, ensuring compliance with regulatory guidelines and internal protocols.
Documented Evidence: Generate scientifically sound documentation that demonstrates systems and processes meet the defined requirements for performance and compliance.
Collaborate with Teams: Work closely with Operations, Quality Assurance, and regulatory teams to ensure that equipment validation activities are aligned with quality and compliance standards.
Process Reviews: Review and assess equipment/system performance against established criteria, identify gaps, and implement corrective actions, as necessary.
Regulatory Compliance: Stay updated on global regulatory requirements and ensure all validation processes comply with the latest guidelines from bodies such as FDA, EMA, and other relevant authorities.
Troubleshooting: Support troubleshooting and root cause analysis related to equipment/system issues during validation and post-validation phases.
Lifecycle Management: Oversee the full lifecycle of validation from initial qualification through periodic requalification to ensure continuous compliance.
Reporting & Documentation: Develop and maintain validation reports, risk assessments, protocols, and final reports.
Qualifications:
Experience: 3+ years of experience in equipment validation within the GMP or pharmaceutical industry.
Education: Bachelor’s degree in engineering, Life Sciences, or a related field (or equivalent work experience).
Skills:
Strong understanding of GMP requirements, industry standards, and global regulatory guidelines.
Proven track record of successful equipment validation projects.
Knowledge of validation methodologies and tools (e.g., IQ/OQ/PQ protocols, risk assessments, etc.).
Ability to collaborate effectively with cross-functional teams (Operations, QA, Regulatory).
Strong written and verbal communication skills.
Excellent attention to detail and problem-solving capabilities.
Certifications: Relevant certifications in validation (e.g., ASQ, ISPE) are a plus.
Location Requirements: Must be based in or willing to relocate to Portsmouth, NH.
Preferred Experience:
Experience with the validation of equipment/systems for biologics or pharmaceuticals manufacturing.
Familiarity with FDA, EMA, and other global regulatory frameworks.
Knowledge of computerized systems validation (CSV) and/or equipment automation.
Job Type: Contract
Pay: $55.37 – $65.00 per hour
Schedule:
Day shift
Experience:
equipment validation: 5 years (Required)
GMP or pharmaceutical industry: 5 years (Required)
Ability to Commute:
Portsmouth, NH 03801 (Required)
Work Location: In person
Title: Principal Quality Auditor
Company: Bausch + Lomb
Location: Greenville, SC
