Job Overview
The Engineering Manager leads all site engineering and maintenance functions in a GMP-regulated CDMO facility. This role ensures safe, compliant, and reliable operation of aseptic manufacturing systems, high-containment equipment, and GMP utilities supporting high-potency drugs, biologics, and parenteral products. The position is critical for maintaining global regulatory readiness and supporting multi-client operations and technology transfers.
About Particle Sciences, an Agno Pharmaceutical Company
Founded in 1991, Particle Sciences is a Bethlehem, Pennsylvania–based pharmaceutical Contract Development and Manufacturing Organization (CDMO) with deep expertise in complex drug product formulation. Originally focused on particle engineering and nanotechnology, the company evolved into a recognized leader in solutions for poorly soluble and highly potent compounds, offering formulation development, analytical services, and cGMP clinical manufacturing.
Acquired by Agno Pharmaceuticals December 2023, we are now part of a global pharmaceutical CDMO. Today, Particle Sciences operates as a division of Agno Pharmaceuticals, continuing to serve pharmaceutical and biotechnology clients worldwide from its Bethlehem facility while building on more than three decades of scientific and technical excellence
Key Responsibilities:
Engineering & Maintenance
- Lead engineering/maintenance teams supporting aseptic fill-finish, isolators/RABS, autoclaves, lyophilizers, implant systems, and containment equipment
- Ensure equipment reliability, uptime, and alignment with production demands
- Implement preventive/predictive maintenance programs
- Manage full equipment lifecycle (URS through decommissioning)
GMP Compliance & Regulatory Readiness
- Ensure compliance with FDA (21 CFR), EU GMP (Annex 1, 15), and ICH guidelines
- Maintain inspection readiness for FDA, EMA, MHRA, and client audits
- Oversee documentation (SOPs, protocols, reports) and support deviations, CAPAs, and change controls
Capital Projects & Tech Transfer
- Lead capital projects (equipment installs, cleanroom upgrades, containment systems)
- Manage budgets, timelines, vendors, and contractors
- Support technology transfer for aseptic processes, biologics, HPAPI, and implants
- Collaborate cross-functionally (Manufacturing, QA, Validation, MSAT, Automation, EHS)
Utilities & Automation
- Oversee GMP utilities (WFI, clean steam, HVAC, gases, vacuum)
- Support automation systems (PLC, SCADA, BMS/EMS)
- Drive reliability, sustainability, and energy efficiency initiatives
Leadership & Operations
- Lead, mentor, and develop engineering staff
- Manage budgets, KPIs, spare parts, and service contracts
Education and Experience Required
- Bachelors degree in engineering (Mechanical, Electrical, Chemical, or related)
- 8–12+ years in pharmaceutical/biotech manufacturing
- 3–5+ years in engineering leadership within GMP environments
- Experience with aseptic systems, isolators, and sterile manufacturing
- Regulatory inspection exposure (EU & US); CDMO experience preferred
Agno Pharmaceuticals is an Equal Opportunity employer
Pay: $100,000.00 - $125,000.00 per year
Benefits:
- 401(k) 5% Match
- Dental insurance
- Disability insurance
- Health insurance
- Health savings account
- Life insurance
- Vision insurance
Work Location: In person
