Senior 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

A leading biopharmaceutical manufacturer is seeking a Senior Lead/ Principal Process Engineer - Aseptic Drug Product Compounding to provide technical leadership for the design, delivery, commissioning, qualification, and start-up of a new state-of-the-art biologics manufacturing facility. The role will serve as the Subject Matter Expert (SME) for aseptic drug product compounding systems, including single-use technologies, stainless steel processing equipment, mixing, filtration, and cleaning/sterilisation systems.

Key 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 closely with Manufacturing, Quality, MSAT, Facilities, Procurement, Engineering, and EHS teams to ensure successful project delivery.
• Drive technical problem solving, compliance, and continuous improvement initiatives.

Requirements

• Bachelor's Degree in Engineering (Chemical Engineering preferred); advanced degree advantageous.
• 10+ years' experience in aseptic drug product compounding within a biotherapeutics cGMP manufacturing environment.
• Hands-on expertise with:
• Single-use technologies and mixers
• 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.

Preferred:

• Experience leading large-scale aseptic bio therapeutic compounding projects valued between $30M-$50M.
• Greenfield or brownfield GMP facility start-up experience.
• Expertise delivering projects from conceptual design through commissioning and operational readiness.

The successful candidate will initially be based in Conshohocken, Pennsylvania, supporting the engineering and project execution phase. Following the first year, the role will transition to Wilson, North Carolina, supporting site commissioning, qualification, and commercial operations