Engineer Process, QC and Calibration Process Development

Job description

As a Process Engineer II (QC and Calibration Process Development), you will support the development, qualification, and continuous improvement of the quality control and calibration processes of immunoassay and PCR-based assays, reagents, and manufacturing processes at our Westbrook, Maine location. Participates on a technically focused team to define technical solutions, exercising consistent discretion and judgment.

Executes experiments and follows standard protocols at the laboratory bench to inform decisions or recommendations on assay performance, calibration and process changes. Uses advanced knowledge and statistical tools such as JMP to analyze, interpret and draw conclusions from varying data and circumstances. Prepares solutions, reagents and immunoassay materials, including antigens, antibodies, conjugates and bead-based components.

Communicates and presents to colleagues and cross-functional partners.

In this role

Prepares materials, performs immunoassay experiments, gathers data, carries out analysis and reaches conclusions. Leads DoEs. Evaluates assay performance, including signal response, calibration, sensitivity and specificity, reproducibility, and lot-to-lot consistency, using JMP for statistical analysis, data visualization and experimental design. Recommends next steps. Prepares and qualifies assay components. May produce and/or test reagents and final products and perform other production-related activities.

Documents experiments and other lab or production activities in accordance with Good Documentation Practices. Prepares reports and summaries, presents results and conclusions, and maintains appropriate records. Participates on and may manage teams, planning and organizing team activities. Leads straightforward projects with small scopes. Collaborates and communicates with Manufacturing, Quality Control, Quality Assurance, Product Support and R&D colleagues to support investigations and change orders, exchange information and ensure efficient processes.

Orders and maintains equipment and work area, including routine instrument maintenance and troubleshooting. Provides guidance within areas of direct expertise and may coach or mentor less experienced colleagues. Maintains knowledge of products and procedures, developments in the field and industry, and the regulatory environment. Adheres to appropriate procedures and regulatory requirements.

What you need to succeed

Hands-on experience with immunoassay techniques (for example, ELISA or similar); reagent preparation and assay troubleshooting experience preferred. 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. JSL scripting is a plus. Ability to design and run experiments, interpret results and make sound, evidence-based recommendations.

Strong documentation skills with a focus on accuracy, traceability and compliance with Good Documentation Practices. Strong communication skills, both verbal and written. Ability to work independently and cooperatively as part of a team. Organizational skills and ability to plan work and manage multiple priorities. Takes initiative and is accountable (shows ownership); focuses on task at hand; detail oriented. Adaptable. Familiarity with quality systems such as ISO 13485 or GMP is preferred.

What You Can Expect From Us

Salary rate targeting $93,000 - 98,000 annually (based on experience) Opportunity for performance based annual merit increase Health / Dental / Vision Benefits available day one of employment Opportunity for annual cash bonus 5% matching 401k Additional benefits including but not limited to financial support, pet insurance, mental health resources, volunteer paid days off, employee stock program, foundation donation matching, and much more!

Schedule

This is a hybrid role based out of our Westbrook, ME corporate headquarters, with a minimum expectation of 3 days a week onsite. Reliable and dependable attendance is an essential function of the position.