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Validation Specialist Aseptic Process Simulation (APS) Temp

Interact Engineering LLC
Whippany, NJ

Quick Apply

Job Details

Temporary
$45 an hour
8 days ago

Qualifications

Biology
USP standards
Chemical Engineering
Sterile processing
Cleanroom environmental monitoring
ISO standards
Bachelor of Science
Drug regulation
GMP
Cleanroom protocols
Microbiology
Manufacturing facility experience
Sterile field contamination management
Production validation processes
Bachelor's degree
Pharmaceutical company experience
Automated systems
Process validation (IQ/OQ/PQ)
Regulatory/legal compliance standards in production
Cleanroom experience
Biomedical regulatory compliance
Microbiological testing for sterile processing
Process simulation
Packaging equipment
Engineering validation
Pharmaceutical manufacturing facility experience

Full Job Description

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

Quick Apply

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