Quality Assurance Csv Engineer

• Support validation testing and provide QA guidance to test discrepancies and exceptions while driving closure to issues.
• Review and execute the configuration specifications of new system design.
• Review traceability matrix to ensure all requirements are linked to testing in order to determine functionality.
• Provide guidance and support to cross-functional teams on validation-related matters, including interpretation of regulations, industry standards, and internal policies.
• Review and approve validation of Air Particle Counters to ensure they are incorporated into the BSC validation scope.
• Review qualification server reports.
• Drive project completion and ensure new system is ready for final release. Support condensed implementation timeline.
• Review and analyze validation summary reports.
• Review and identify existing MES and LIMS data migration and Quality documentation.
• Additional duties as assigned.
• Conduct risk assessments and gap analyses to identify validation requirements and develop mitigation plans.
• Data Integrity and 21 CFR part 11Compliance.
• Develop and execute computer system validation strategies and plans in accordance with regulatory requirements, industry standards, and company policies.
• Support the laboratory instrument integration processes and tasks.
• Ensure all data is properly transferred over to new server, including required data verification.
• Review computer system impact assessment for new electronic logbook.
• Support the validation plan, reviewing all necessary requirements for system data migration tasks and new system release efforts.
• Ensure validation protocols meet user requirements, design configuration, and internal and industry regulatory requirements.
• Review user requirements for current system software upgrades and new system user requirement specifications.

Requirements

• Excellent analytical and problem-solving skills with a keen attention to detail.
• Ability to work collaboratively in a cross-functional team environment and manage multiple projects simultaneously.
• 5+ years of experience supporting GxP computer system implementation and validation.
• Bachelors degree in engineering or related.
• At PSC Biotech, many of our projects and clients are located in various regions around the country. Therefore, we value candidates who are willing and able to travel as needed for project assignments and client engagements. The ability to adapt to different locations, cultures, and work environments is essential, as it allows our team members to collaborate effectively with clients and colleagues nationally.
• Effective communication skills with the ability to convey complex technical concepts to both technical and non-technical stakeholders.
• Experience developing and executing protocols for single-use process systems, lab systems, and software applications in a cGMP environment.
• Strong understanding of validation concepts and techniques, including risk assessment, test design, and documentation.
• 3+ years of quality assurance experience.
• In-depth knowledge of regulatory requirements and industry standards related to computer system validation.
• 5+ years of experience in the biotech/pharmaceutical industry.
• Experience utilizing risk-based assessments for manufacturing and laboratory systems.

Benefits

• 401(k) and 401(k) matching
• Medical, Dental, and Vision - PSC pays 100% of all qualifying employee medical premiums and 50% for qualifying dependents
• Pet Insurance
• PTO, Sick Time, and Paid Holidays
• Insurance options for Employee Assistance Programs, Basic Life Insurance, Short/Long Term Disability and more.
• Education Assistance
• Financial Perks and Discounts
• Discounted rate at Anytime Fitness