We are looking for a proven Quality/Validation resource to join our Life Sciences team in support of a pharmaceutical client in the Boston, MA area. This individual will be primarily responsible for assisting the Quality group with the review and approval of specifications, user acceptance testing, etc. (primarily for Manufacturing Execution Systems – MES).

Ideal candidates should have previous experience being responsible for preparing and reviewing CSV protocols, reports, and procedures for GMP controls and computerized systems; the review and approval of change controls; and auditing of CSV documentation for compliance with current corporate, FDA and regulatory requirements. Ideal candidates should have a strong understanding of GMPs and experience providing engineering support in highly regulated or pharmaceutical/ biotech facilities.

Roles and Responsibilities:

• Understand development of CSV and equipment specifications and executing Computer System Validation, System Development Life Cycle (SDLC), and other pharmaceutical equipment/system commissioning/validation (IQ/OQ/PQ) protocols in accordance with Good Engineering Practices, GAMP, local SOPs, industry best practices and other industry related guidance documents.
• Assess the impact of changes to cGMP equipment/systems and methods and establish the applicable Validation Plan to ensure the validated status following changes.
• Experience in technical writing and report generation of testing methodologies of automated systems.
• Expertise in evaluating validation protocols and summary reports.
• Strong understanding of Testing and Software Development Lifecycle and QA methodologies.
• Responsible for being a quality contact and primary Subject Matter Expert (SME) for complex deviations for systems, processes, and equipment related to engineering, facilities, automation, manufacturing, and validation.
• Support and review complex deviation investigations related to manufacturing process equipment, utilities, automation, validation, and engineering.
• Work closely with Operations, Facilities, Manufacturing, Automation, Validation, and Engineering to resolve open issues resulting from equipment failures, issues, and deviation record reviews.
• Lead the QA review and assessments of deviations; includes performing risk assessments, leading root cause analysis investigations, tracking, follow-up, close out, and reporting/trending.

Position Requirements and Qualifications:

• 5+ years of demonstrated experience in cGMP automation/computerized systems, quality, and compliance areas in the pharmaceutical industry.
• Thorough understanding of industry standards and best practices for computer system validation.
• Broad range of experience with validation of equipment controlled by PLCs, BAS/BMS systems, DeltaV, and other typical automated system platforms preferred.

Education:

Bachelor’s Degree in Science or related technical field.