Senior Aseptic Process Engineer – Drug Product

Blackfield Associates; Conshohocken (Montgomery County); On-site; USD 140,000 - 210,000; Full time

Job summary

Blackfield Associates seeks a Senior Lead/Principal Process Engineer to provide technical leadership for aseptic drug product compounding in support of a new state-of-the-art biologics facility. This role oversees design, commissioning, qualification, and startup activities, serving as SME for single-use tech, stainless steel systems, and cleaning/sterilisation processes.

You will collaborate with Manufacturing, Quality, MSAT, Facilities, Procurement, and Engineering teams to ensure project

Qualifications

• Bachelor's Degree in Engineering (Chemical Engineering preferred).
• 10+ years' experience in aseptic drug product compounding within a biotherapeutics cGMP manufacturing environment.
• Hands-on expertise with single-use technologies and mixers.
• Experience with stainless steel tank design, cleaning and sterilisation systems, mixing and filtration operations.
• Proven experience leading capital projects, commissioning and qualification activities, and facility start-ups.
• Strong knowledge of cGMP requirements, process engineering, and aseptic manufacturing operations.

Responsibilities

• Lead the design and implementation of aseptic drug product compounding systems and suites.
• Develop engineering documentation including URS, P&IDs, PFDs, technical specifications, and equipment data sheets.
• Provide technical leadership for single-use mixers, stainless steel vessels, COP/SOP systems, filtration, and associated processing equipment.
• Manage vendor selection, equipment design reviews, and project execution activities.
• Lead FAT, SAT, Commissioning & Qualification (C&Q), and operational start-up activities.
• Partner with Manufacturing, Quality, MSAT, Facilities, Procurement, Engineering, and EHS teams for successful project delivery.
• Drive technical problem solving, compliance, and continuous improvement initiatives.

Skills

Single-use tech

Mixers

Stainless steel tank design

Cleaning & sterilisation

Mixing & filtration

cGMP

Process engineering

Aseptic manufacturing operations

Project leadership

Education

Bachelor's Degree in Engineering

Tools

URS

P&IDs

PFDs

Technical specifications

Equipment data sheets

Job description

Blackfield Associates seeks a Senior Lead/Principal Process Engineer to provide technical leadership for aseptic drug product compounding in support of a new state-of-the-art biologics facility. This role oversees design, commissioning, qualification, and startup activities, serving as SME for single-use tech, stainless steel systems, and cleaning/sterilisation processes.

You will collaborate with Manufacturing, Quality, MSAT, Facilities, Procurement, and Engineering teams to ensure project