Process Engineer

Abzena Inc. • Bristol, PA

12d

About The Position

With extensive experience in developing biologics and bioconjugates, we offer a seamless service delivered by fully integrated teams, from early discovery to commercial manufacturing.

Forward-thinking and committed, we find the best solution and use the right technologies to design, develop and manufacture your products to ensure we get vital medicines to patients quickly and safely.

We are dedicated to quality excellence. We are driven to get better treatments to market, efficiently and responsibly by reducing timelines and delivering the highest quality products and services.

We are Abzena. More than a CDMO, we are a responsible and dedicated partner that takes care of your products from concept to patient.

The Process Engineer supports the design, optimization, and execution of antibody‑drug conjugate (ADC) and biologics manufacturing processes. This role is responsible for implementing closed‑processing improvements, ensuring GMP equipment readiness, designing single‑use consumables, resolving technical issues, and developing mass balance and process monitoring tools. The Process Engineer also supports ADC‑specific needs, including handling highly potent APIs (HPAPIs), supporting conjugation process characterization, performing scale‑up/scale‑down assessments, collaborating on technology transfers, and developing workflows for buffers and HPAPI waste.
This role requires strong technical judgment, cross‑functional collaboration, and the ability to perform hands‑on support in a fast‑paced GMP manufacturing environment.

Requirements

• Bachelor’s degree in Chemical, Biomedical Engineering or related scientific field.
• 3–5 years of experience in biopharmaceutical and/or biologics.
• Strong understanding of GMP operations and equipment used in biologics/ADC processing.
• Experience with mass balance modeling, process characterization, or engineering analyses.
• Ability to write technical documentation including SOPs, deviations/CAPAs, protocols, and reports.
• Demonstrated ability to support investigations, troubleshooting, and root‑cause analysis.
• Strong communication skills and ability to work effectively across teams.
• Project management experience, including scheduling, risk evaluation, and coordination.

Nice To Haves

• 2+ years of experience in ADC manufacturing, MSAT or process engineering

Responsibilities

• Process Development, Characterization & Scale‑Up
• Lead closed‑processing improvement initiatives across conjugation and purification operations.
• Support characterization studies, including DOEs to assess process robustness and critical process parameters.
• Perform scale‑up and scale‑down assessments for conjugation, purification, and formulation steps.
• Support engineering runs and process modeling activities.
• ADC & High‑Potency Processing
• Support handling strategies for high‑potency APIs and payloads, including containment, zoning, and workflow design.
• Perform risk assessments (FMEA, HAZOP, potent‑compound assessments) and implement CAPAs tied to deviations.
• Partner with EHS and Operations to ensure closed‑processing and operator protection requirements are met.
• Support evaluation and implementation of equipment and consumables compatible with HPAPI containment levels.
• Consumable, Raw Material & Single‑Use System Design
• Lead design and optimization of tubing sets, flow‑paths, and single‑use assemblies for ADC processes.
• Support raw material and consumable qualification activities, including evaluation of linkers, solvents, and process reagents.
• Partner with vendors on customization, testing, and introduction of new technologies.
• Process Monitoring, Data Trending & Mass Balance
• Develop and maintain mass balance tools for ADC and biologics workflows.
• Build process monitoring dashboards to track yields, CPPs, DAR (Drug‑to‑Antibody Ratio), impurities, and cycle times.
• Support Continued Process Verification (CPV) activities.
• Technology Transfer
• Participate in internal and external tech transfers by supporting gap analyses, equipment fit studies, and material/component mapping.
• Support first‑in‑plant demonstrations, engineering batches, and troubleshooting during transfer.
• GMP Equipment & Facility Readiness
• Support equipment readiness through URS review, FAT/SAT execution, qualification support, and lifecycle documentation.
• Troubleshoot equipment and process issues in partnership with Facilities, MSAT, QA, and Manufacturing.
• Validation & Compliance
• Support process validation activities, including protocol writing, execution assistance, data analysis, and reporting.
• Ensure compliance with GMP standards, site procedures, and regulatory expectations.
• Support both internal and external audits. Address audit actions with a timely action driving resolution and compliance.
• Buffer & Waste Workflow Optimization
• Design and improve workflows for buffer preparation, hold strategies, and in‑process sampling.
• Support capacity modeling, facility fit assessments, and workflow optimization.
• Documentation & Technical Support
• Author or revise SOPs, P&IDs, equipment matrices, and process flow diagrams.
• Provide on‑the‑floor support during manufacturing operations, including troubleshooting deviations and supporting investigations.
• Prepare technical presentations and reports for internal teams and external partners.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 101-250 employees