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 facility

Experience 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