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

Particle Sciences Inc, an Agno Pharma Company

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Engineering Manager