Process Engineer (Sterile Injectable Manufacturing)

Location: York, United States

Company

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

What you will do

• Lead process transfer activities from clients into sterile injectable manufacturing operations.
• Develop and optimize processes for aseptic fill-finish, sterile filtration, compounding, lyophilization, and packaging.
• Provide technical floor support during manufacturing campaigns and troubleshoot deviations, equipment issues, yield losses, and process excursions.
• Author and execute process validation plans, PPQ protocols and reports, CPV programs, risk assessments, and media fill protocols.
• Support qualification and implementation of filling lines, isolators, RABS, lyophilizers, CIP/SIP systems, filtration systems, and compounding equipment.
• Lead Lean Manufacturing, operational excellence, OEE, process robustness, and reliability improvement initiatives.

Requirements

• Bachelor’s degree in Chemical, Biochemical, Mechanical, Pharmaceutical Engineering, Biotechnology, or a related engineering discipline.
• 4–8 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.
• Strong understanding of aseptic processing, sterile manufacturing, cGMP requirements, process validation, and pharmaceutical engineering principles.
• Ability to collaborate with Manufacturing, Quality, Validation, Facilities, Metrology, Supply Chain, and client project teams.

Nice to have

• CDMO experience or experience with biologics, vaccines, mAbs, gene therapy products, peptides, or sterile small molecules.
• Experience with lyophilization cycle development and optimization.
• Familiarity with EU GMP 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% of qualifying dependent premiums.
• 401(k) plan with matching, PTO, sick time, and paid holidays.
• Basic life insurance, short- and long-term disability, and employee assistance programs.
• Education assistance, pet insurance, fitness benefits, and financial discounts.
• Coaching and professional development support within a multicultural organization operating globally.