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. 22, and ISO 14644 cleanroom
standards
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