Process Engineer II (QC and Calibration Process Development)

Location: Hybrid role based out of the Westbrook, Maine corporate headquarters, with a minimum expectation of 3 days onsite per week.

Salary: $93,000–$98,000 annually, based on experience.

Company

hirify.global develops diagnostic products and technologies, including immunoassay and PCR-based assays, reagents, and related manufacturing processes.

What you will do

• Develop, qualify, and continuously improve quality control and calibration processes for immunoassays, PCR-based assays, reagents, and manufacturing processes.
• Prepare materials and reagents, perform immunoassay experiments, collect and analyze data, lead DoEs, and make recommendations.
• Evaluate assay performance, including signal response, calibration, sensitivity, specificity, reproducibility, and lot-to-lot consistency, using JMP.
• Prepare and qualify assay components; produce or test reagents and final products and support production activities.
• Document laboratory and production activities, prepare reports, present results, and maintain records in accordance with Good Documentation Practices.
• Collaborate with Manufacturing, Quality Control, Quality Assurance, Product Support, and R&D on investigations, change orders, equipment maintenance, troubleshooting, and process improvements.

Requirements

• Hands-on experience with immunoassay techniques such as ELISA or similar.
• Laboratory bench and instrumentation skills, including routine instrument maintenance and troubleshooting.
• Analytical and problem-solving skills, including proficiency in JMP for statistical analysis, data visualization, and design of experiments.
• Ability to design and run experiments, interpret results, and make evidence-based recommendations.
• Strong written and verbal communication, documentation, organization, and prioritization skills.
• Ability to work independently and cooperatively in a team, take initiative, demonstrate accountability, remain adaptable, and maintain attention to detail.
• Reliable and dependable attendance is an essential function of the position.

Nice to have

• Reagent preparation and assay troubleshooting experience.
• JSL scripting experience.
• Familiarity with quality systems such as ISO 13485 or GMP.

Culture & Benefits

• Hybrid work arrangement with at least 3 onsite days per week.
• Health, dental, and vision benefits available from the first day of employment.
• Performance-based annual merit increase and annual cash bonus opportunity.
• 5% 401(k) matching.
• Additional benefits include financial support, pet insurance, mental health resources, paid volunteer days, employee stock program, and foundation donation matching.