What are the responsibilities and job description for the Senior Process Engineer position at ELIQUENT Life Sciences?
About Company:
Who Are We?
ELIQUENT Life Sciences is a leading global consulting group delivering regulatory affairs, pharmacovigilance, quality, and compliance solutions that support pharmaceutical, biotechnology, medical device, and combination product companies across therapeutic modalities, phase-based pathways, and major global markets.
Why explore your future at ELIQUENT?
ELIQUENT Life Sciences is a trusted global consulting firm helping life sciences companies navigate regulatory complexity and bring breakthrough therapies to market. Founded by former regulators and industry experts, we offer end-to-end support in regulatory affairs, pharmacovigilance, and quality compliance. Our team is driven by a shared mission to improve global health through innovation, collaboration, and integrity. At ELIQUENT, you will be part of a purpose-led organization where your expertise contributes to meaningful impact and your growth is supported every step of the way.
About the Role:
Provide Manufacturing Science and Technology (MSAT), Process Engineering, and Validation support for sterile fill/finish manufacturing operations, supporting reliable operation, qualification, and lifecycle management of aseptic processing equipment and manufacturing processes.
Key Responsibilities:
- Provide MSAT and Process Engineering support for sterile filling, formulation/compounding, aseptic processing, component preparation, and packaging operations.
- Support process design, equipment selection, commissioning, qualification, and operational readiness for fill/finish manufacturing systems and equipment.
- Develop and execute process validation and equipment qualification protocols, including IQ/OQ/PQ and continued process verification activities.
- Support aseptic filling lines, vial/syringe filling equipment, isolators/RABS, autoclaves, washers, depyrogenation tunnels, formulation vessels, and associated clean utilities.
- Lead or support technical investigations for process deviations, equipment performance issues, filling defects, environmental excursions, and process variability, utilizing structured root-cause analysis and CAPA.
- Evaluat critical process parameters (CPPs) and critical quality attributes (CQAs) to ensure manufacturing processes remained within validated operating ranges.
- Support aseptic process simulations/media fills, cleaning validation, sterilization validation, and equipment/process requalification activities.
- Author and review URS, technical specifications, risk assessments, qualification protocols/reports, validation plans, SOPs, engineering studies, and change controls.
- Perform process characterization, engineering studies, and troubleshooting to improve yield, cycle time, equipment reliability, process robustness, and manufacturing performance.
- Provid technical support for technology transfer, scale-up, process implementation, and transfer from development into GMP manufacturing.
- Partner with Manufacturing, Quality, Validation, Automation, Engineering, Microbiology, and Operations teams to resolve technical issues and maintain inspection-ready documentation.
- Support investigations and implementation of CAPAs associated with aseptic processing, equipment, process performance, and validation.
- Apply risk-based approaches including FMEA and process risk assessments to evaluate equipment and manufacturing process changes.
- Support change control and validation impact assessments for modifications to equipment, automation, recipes, process parameters, and manufacturing procedures.