Process Engineer

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

As a Process Engineer within the manufacturing industry, you will play a critical role in designing, implementing, and optimizing chemical and manufacturing processes to enhance efficiency and product quality.

Responsibilities

· Draft, review, and execute process development, characterization, and validation protocols for Drug Product operations· Support thaw, formulation, dilution, and vial filling unit operations· Analyze data and write summary reports, deviation investigations, and impact assessments· Use validated change control systems to implement process or equipment modifications· Review and update core technical documents including URS, FS, DDS, and P&IDs· Partner with Manufacturing and Quality to deliver projects on time and maintain audit readiness· Follow site SOPs, Good Documentation Practices, and cGMP requirements

Qualifications

· Bachelor's degree in Chemical, Bio, Mechanical Engineering, or a related scientific discipline· 5+ years of engineering or validation experience in a cGMP pharmaceutical facilityExperience with tech transfers· Hands-on Drug Product experience with vial filling, formulation, dilution, and thaw operations· Experience with process development and writing and executing IQ/OQ/PQ protocols· Experience managing formal change controls· Ability to understand and work with URS, FS, DDS, and P&IDs· Strong technical writing skills for protocols, reports, deviations, and impact assessments