Senior Process Engineer (Sterile Injectable Manufacturing)

Location: York, United States. Must be authorized to work in the U.S.

Company

hirify.global operates BioTechnique, a sterile injectable full-service CDMO providing formulation, compounding, aseptic fill-finish, and lyophilization services from development through commercial production.

What you will do

• Lead client process transfers into manufacturing operations and develop strategies for aseptic fill-finish, sterile filtration, compounding, lyophilization, and packaging.
• Provide technical floor support during aseptic manufacturing campaigns and troubleshoot deviations, equipment issues, yield losses, and process excursions.
• Author and execute process validation master plans, PPQ protocols and reports, CPV programs, risk assessments, and media-fill protocols.
• Analyze process data, support investigations and CAPAs, and drive improvements in throughput, quality, efficiency, robustness, and reliability.
• Support qualification and implementation of filling lines, isolators, RABS, lyophilizers, CIP/SIP systems, filtration and compounding equipment, and visual inspection systems.
• Support regulatory inspections, client audits, contamination-control initiatives, and technical documentation for submissions.

Requirements

• Bachelor’s degree in chemical, biochemical, mechanical, pharmaceutical engineering, biotechnology, or a related engineering discipline.
• 7+ years of pharmaceutical manufacturing experience, including at least 3 years supporting aseptic manufacturing operations.
• Experience with sterile injectable manufacturing, fill-finish operations, GMP documentation, process investigations, technology transfer, and process validation.
• U.S. work authorization is required.
• C2C arrangements are not accepted.

Nice to have

• CDMO experience and experience with biologics, vaccines, mAbs, gene therapy products, peptides, or sterile small molecules.
• Lyophilization cycle development and optimization experience.
• Familiarity with Annex 1 contamination-control requirements.
• Project management experience.
• Six Sigma Green Belt or Black Belt certification.

Culture & Benefits

• Medical, dental, and vision coverage, with PSC paying 100% of qualifying employee medical premiums and 50% for qualifying dependents.
• 401(k) plan with matching contributions.
• PTO, sick time, and paid holidays.
• Education assistance, pet insurance, fitness benefits, and financial discounts.
• Employee assistance, life insurance, and short- and long-term disability options.