Process Engineer II, Manufacturing Process Validation & Equipment Qualification

Location: Springfield, New Jersey, United States; hybrid with on-site presence three days per week. Applicants must be authorized to work for any employer within the United States.

Salary: $89,000–$148,000 annually, plus eligibility for a discretionary performance-based cash incentive.

Company

hirify.global is a radiopharmaceutical-focused company developing solutions across oncology, neurology, and cardiology to improve patient outcomes.

What you will do

• Provide technical ownership and engineering support for pharmaceutical and radiopharmaceutical manufacturing processes from technology transfer through commercial manufacturing.
• Design, implement, qualify, and manage the lifecycle of manufacturing equipment, utilities, automation systems, facilities, cleaning, and sterilization processes.
• Author and review URS, system definitions, risk assessments, qualification and validation protocols, test plans, engineering studies, investigations, and final reports.
• Lead and execute commissioning, qualification, verification, performance qualification, requalification, and process validation activities using risk-based validation practices.
• Provide on-floor technical support during engineering, clinical, validation, and commercial manufacturing campaigns, including investigation and process-monitoring support.
• Represent Process Validation on cross-functional teams, support inspection readiness and audits, and lead continuous-improvement initiatives for procedures, templates, and best practices.

Requirements

• Bachelor’s degree in engineering, Life Sciences, or a related scientific discipline.
• At least 3 years of process and/or equipment validation experience in the pharmaceutical, biopharmaceutical, or medical device industry.
• Hands-on validation experience with pharmaceutical manufacturing processes and systems, including radiopharmaceutical dispensing systems and radiopharmaceutical synthesizers.
• Knowledge of cGMP requirements, pharmaceutical process validation practices, and change control processes.
• Ability to author clear and compliant technical documentation, including validation protocols, test plans, and reports.
• Ability to work independently and collaborate with Manufacturing, Engineering, Quality, MSAT, contractors, consultants, and vendors.
• Willingness and ability to work onsite as required to support manufacturing operations.

Nice to have

• Experience supporting aseptic fill-finish operations and validating vial filling lines and aseptic manufacturing technologies.
• Strong organizational, analytical, problem-solving, verbal communication, and written communication skills.
• Experience presenting validation strategies and outcomes.
• Experience with project management and documentation tools such as Microsoft Project, Visio, and Microsoft Office.

Culture & Benefits

• Values include accountability, quality, efficiency, customer service, collaboration, safety, respect, adaptability, and ownership.
• Comprehensive medical, prescription drug, dental, and vision coverage.
• Life and disability benefits, pre-tax accounts, and a 401(k) with company contribution.
• Paid vacation, holidays, sick days, and parental leave.
• Equal employment opportunity and accommodation support are provided; hirify.global is an E-Verify employer.

Hiring process

• Applications are submitted through hirify.global.com and are accepted until December 4, 2026.
• Applicants requiring an accommodation during hiring or to perform essential job functions may contact the hirify.global Talent Acquisition team.