Process Engineer / Process Specialist – Downstream Manufacturing (Biologics)

Overview

We are seeking a Process Engineer / Process Specialist to provide technical support for downstream biologics manufacturing operations. This role is responsible for ensuring robust manufacturing processes through process optimization, troubleshooting, validation support, and continuous improvement initiatives while maintaining compliance with cGMP standards.

The successful candidate should have strong hands-on experience in downstream processing equipment and manufacturing operations, with the ability to collaborate across Production, QA, QC, Engineering, Validation, and MSAT teams to improve process performance and manufacturing reliability.

Key Responsibilities

• Provide day-to-day engineering and technical support for downstream manufacturing operations.
• Monitor manufacturing performance and identify opportunities for process optimization, cycle time reduction, and yield improvement.
• Lead and support root cause investigations for process deviations, equipment issues, and manufacturing excursions.
• Initiate and implement CAPAs and continuous improvement projects to improve process robustness and operational efficiency.
• Support technology transfer, process validation (PV), cleaning validation (CV), and commissioning/qualification activities.
• Develop, review, and revise SOPs, batch records, work instructions, and manufacturing documentation.
• Perform process trend analysis using manufacturing data to identify improvement opportunities.
• Support change controls, risk assessments, and deviation investigations in accordance with GMP requirements.
• Work closely with Production, QA, QC, Validation, Engineering, and Supply Chain to ensure smooth manufacturing execution.
• Participate in equipment troubleshooting, preventive maintenance planning, and process optimization activities.
• Support regulatory inspections and customer audits by providing technical documentation and subject matter expertise.
• Mentor manufacturing personnel on new processes, procedures, and best practices where required.

Technical Requirements

Candidates should have hands-on experience with several of the following:

• Downstream biologics manufacturing processes
• Chromatography systems (Protein A, Ion Exchange, RP-HPLC, LPLC or similar)
• Column packing, unpacking and HETP testing
• Buffer and media preparation
• Depth filtration and TFF/UFDF systems
• Centrifugation
• CIP/SIP systems
• Filtration integrity testing
• Cleaning validation and process validation
• GMP manufacturing equipment
• DeltaV, UNICORN, MES or other manufacturing automation systems
• LIMS and electronic documentation systems

Preferred Experience

• 4–8 years of experience within biologics, biotechnology, pharmaceutical, vaccine, or cell culture manufacturing environments.
• Strong understanding of cGMP, GDP, data integrity, and regulatory expectations.
• Experience supporting large-scale or commercial downstream manufacturing.
• Proven experience in process troubleshooting and continuous improvement projects.
• Experience with deviation investigations, CAPA, change control, and risk assessments.
• Exposure to tech transfer or manufacturing science activities would be advantageous.

Qualifications

• Bachelor's Degree in Biotechnology, Biochemical Engineering, Chemical Engineering, Life Sciences, or a related discipline.
• Strong analytical and problem-solving skills.
• Excellent communication and cross-functional stakeholder management abilities.
• Ability to work independently while supporting multidisciplinary manufacturing teams.