Overview

A contract development and manufacturing organization that specializes in producing topical, semi-solid, and liquid pharmaceutical products for both prescription and over-the-counter markets. It supports clients through formulation, scale-up, manufacturing, and packaging, with a strong focus on quality, regulatory compliance, and speed to market. This role is critical to demonstrating ongoing aseptic process capability and to supporting the commercial launch of sterile injectable products. The successful candidate will bring deep technical knowledge of media fill program design, microbiological principles, isolator and RABS operations, and current regulatory expectations, and will thrive in a hands-on, in house qualification environment. Key Responsibilities Aseptic Process Simulation Program Ownership Design, author, and maintain the site APS program based on a media fill model, encompassing worst-case process simulation parameters consistent with commercial filling operations. Author and revise APS protocols, batch records, and summary reports for initial qualification runs and routine periodic media fills. Establish and maintain APS bracketing and worst-case rationale documentation (e.g., shift duration, personnel interventions, line speed, container-closure configurations) in compliance with FDA and EU GMP Annex 1 requirements. Manage the media fill schedule, ensuring fills are conducted at defined intervals per regulatory requirements and internal SOPs. Execution and Operations Lead hands-on execution of media fills on the Groninger UFVN FlexFill filling line and SKAN isolator, including gowning, line setup, aseptic manipulations, and interventions representative of commercial operations. Coordinate all personnel involved in APS activities, including training on roles, responsibilities, and correct aseptic technique during simulation runs. Oversee incubation, inspection, and disposition of filled media units; investigate and document any positive units in accordance with site investigation procedures. Ensure all APS activities are executed in accordance with approved protocols and cGMP requirements; escalate deviations or unexpected results in a timely manner. Equipment Qualification and Utility Interface Interface with IQ/OQ/PQ activities for the sterile filling line, SKAN isolator, environmental monitoring systems, and associated critical utilities (compressed air, nitrogen, WFI, clean steam) as they relate to APS readiness. Support environmental monitoring (EM) program execution during media fills, including viable and non-viable particulate monitoring in ISO 5 / Grade A and ISO 7 / Grade B classified environments. Collaborate on HVAC qualification and room classification studies to ensure the aseptic processing suite meets regulatory expectations prior to and during APS execution. Documentation and Regulatory Compliance Author, review, and maintain APS-related SOPs, risk assessments, and Validation Master Plan (VMP) sections covering aseptic process simulation. Prepare APS summary reports suitable for regulatory submissions (NDA/ANDA CMC sections, pre-approval inspections, and BLA filings). Maintain APS program documentation in an inspection-ready state at all times; serve as the subject-matter expert (SME) for FDA, Health Canada, EMA, and client audits. Ensure all APS activities are traceable to applicable equipment qualification activities (IQ/OQ/PQ) and facility qualification records. Track and trend APS results over time; identify adverse trends and initiate CAPAs as appropriate. Bachelor of Science in Microbiology, Biology, Pharmacy, Chemical Engineering, or a related life science discipline Experience Minimum 3-5 years of pharmaceutical validation experience with direct hands on experience in aseptic process simulation and media fills in a cGMP sterile manufacturing environment Regulatory Knowledge Working knowledge of FDA 21 CFR Parts 210/211, EU GMP Annex 1 (2022 revision), USP 1116, PDA Technical Report No. 2