Process Engineer, MS&T (Pharmaceutical Manufacturing)

Location: On-site in Middletown, Delaware, United States.

Company

hirify.global provides pharmaceutical manufacturing and customer-focused CDMO services.

What you will do

• Lead internal and external technology transfers, new product introductions, process fit-gap assessments, scale-up activities, and manufacturing readiness reviews.
• Own assigned commercial products as the technical process SME throughout the lifecycle, including process improvements, CPV programs, APQRs, and state-of-control activities.
• Develop, review, and execute process validation, cleaning validation, PPQ, CPV, risk assessment, and validation summary documentation.
• Provide direct technical support for commercial manufacturing, investigate deviations and manufacturing events, perform root cause analysis, and implement CAPAs.
• Support change controls, regulatory submissions, customer audits, agency inspections, and compliance with cGMP, FDA, EMA, and ICH requirements.
• As site capabilities expand, support sterile product transfers, aseptic processing, sterile validation, facility startup, qualification, contamination control, and sterility assurance activities.

Requirements

• Bachelor’s degree in Chemical Engineering, Pharmaceutical Engineering, Pharmaceutical Sciences, Chemistry, Biochemistry, or a related scientific discipline; an advanced degree is preferred.
• Bachelor’s degree with 8+ years of pharmaceutical manufacturing experience, or a master’s degree with 6+ years of pharmaceutical manufacturing experience.
• Demonstrated experience leading complex technical projects in a GMP environment.
• Experience in several of the following: Oral Solid Dosage manufacturing, technology transfer, NPI, process validation, PPQ, CPV, commercial manufacturing support, investigation and root cause analysis, direct compression, dry or wet granulation, roller compaction, compression, capsule filling, film coating, and packaging operations.
• Strong understanding of cGMP principles, pharmaceutical manufacturing regulations, FDA, EMA, ICH Q8, Q9, and Q10, and lifecycle process validation.
• Experience applying risk management methodologies and scientific decision-making, analyzing manufacturing data, and using statistical tools for process decisions.
• Strong troubleshooting, root cause investigation, technical writing, communication, presentation, project leadership, and organizational skills.
• Ability to lead cross-functional teams and influence stakeholders without direct authority.

Nice to have

• CDMO experience, including customer-facing technical support, commercial product launches, multi-product manufacturing environments, and technology transfers across sites or organizations.
• Sterile manufacturing experience in aseptic processing, sterile drug product manufacturing, sterile filling, lyophilization, terminal sterilization, isolator or RABS technology, sterility assurance, media fills, environmental monitoring, contamination control strategy, sterile process validation, or Annex 1 compliance.

Culture & Benefits

• Cross-functional collaboration with Manufacturing, Quality, Engineering, Supply Chain, Regulatory Affairs, customers, and development organizations.
• Customer-focused environment supporting product commercialization and technical delivery.
• Opportunity to support both current oral solid dosage operations and the future expansion of sterile manufacturing capabilities.
• Success is measured through transfer and NPI execution, validation and PPQ delivery, process performance, deviation and CAPA closure, process improvement, customer satisfaction, and audit readiness.