Overview
Validation Specialist Aseptic Process Simulation (APS) Temp Jobs in Whippany, NJ at Interact Engineering LLC
Job Description
Validation Specialist – Aseptic Process Simulation (APS)
Sterile Injectable Manufacturing | Whippany, New Jersey
Position Summary
Halo Pharmaceutical, a leading North American CDMO is expanding its sterile injectable manufacturing capabilities at its Whippany, NJ facility with a new syringe, cartridge, and vial filling line. As part of this expansion, we are seeking a highly skilled Validation Specialist – Aseptic Process Simulation (APS) to own, execute, and continuously manage our 20-hour time-based media fill program in accordance with FDA, EU GMP Annex 1, and USP requirements.
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.
Cross-Functional Collaboration
- Partner with Manufacturing, Quality Assurance, Microbiology, and Regulatory Affairs teams to integrate APS requirements into new product introductions and technology transfers.
Required Qualifications
Education
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
Technical Skills
- Experience with isolator technology (SKAN or equivalent), automated filling equipment, and environmental monitoring systems; familiarity with vial, syringe, and cartridge fill-finish operations preferred.
Preferred Qualifications
- Experience with 20-hour or extended-duration time-based media fill programs.
- Familiarity with Groninger FlexFill or similar high-speed fill-finish platforms.
- Background in CDMO environments with multi-product aseptic manufacturing portfolios.
- Experience supporting FDA pre-approval inspections (PAIs) or Health Canada GMP inspections as the APS subject-matter expert.
- Knowledge of risk-based Contamination Control Strategies (CCS) as required by EU GMP Annex 1 (2022).
- ASQ Certified Quality Engineer (CQE), PDA training, or equivalent professional certification preferred.
Core Competencies
Technical Precision
Deep understanding of aseptic processing science, microbiological risk, and contamination control in sterile drug manufacturing
Regulatory Acumen
Ability to translate current regulatory guidance into site-specific APS program design and compliant documentation
Attention to Detail
Meticulous in protocol execution, GMP documentation, and data integrity compliance
Problem Solving
Skilled in root cause investigation for APS failures or positive unit events, including CAPA development and effectiveness monitoring
Collaboration
Works effectively across Manufacturing, QA, Microbiology, Regulatory Affairs, and client teams in a fast-paced CDMO environment
Communication
Clear and concise technical writing and verbal communication skills, including the ability to present validation data to regulatory agencies and clients
Job Type: Temporary
Pay: $45.00 per hour
Work Location: In person
Title: Validation Specialist Aseptic Process Simulation (APS) Temp
Company: Interact Engineering LLC
Location: Whippany, NJ
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