Looking for a Sr. Validation Consultant to lead a 3 – 6 month plus project in Boston, MA.
5-7 years experience with 3-5 being in media fills.
• Lead and perform gap analysis of the site’s validation program against current industry regulations and develop validation technical policies and procedures (VMP, Master Standard Operating Procedures, Project Plans etc.) to correct gaps as required.
The consultant should be more quality and validation heavy – less production
• Provide strong technical guidance and strategy for aseptic media fill-finish manufacturing equipment commissioning and qualification activities including but not limited to development of validation strategy, OOS/OOT investigation, process deviation impact, root cause investigation, process change and optimization.
• Lead, coordinate and facilitate aseptic media fill and periodic review activities.
• Lead, collaborate and address quality standards for GMP equipment and systems.
• MUST be able to write and execute protocols, reports, deviations, gap analyses, risk assessments, etc for aseptic/ media fill processing
• Write Summary reports for Commissioning, IOQ and PQ qualification documents. MVPs and Periodic Reviews.
• Collaborate with cross-functional team and ensure timely completion of project deliverables.
• Apply CGMP and CGDP to all areas of work and independently author and manage execution studies for new equipment and utilities
Also Must have:
– Media Fills/Aseptic Processing
– Write and execute protocols
Boston: Sr. Validation Consultant – Aseptic Processing Lead (232492)