Engineer Process, QC and Calibration Process Development

Idexx•Westbrook, ID

7d•Hybrid

About The Position

As a Process Engineer II focused on QC and Calibration Process Development, you will support the development, qualification, and continuous improvement of quality control and calibration processes for immunoassay and PCR-based assays, reagents, and manufacturing processes. You will work on a technically focused team, use discretion and judgment to define technical solutions, and conduct laboratory experiments to inform decisions about assay performance, calibration, and process changes. The role involves preparing solutions, reagents, and immunoassay materials, including antigens, antibodies, conjugates, and bead-based components. You will analyze and interpret data using statistical tools such as JMP, communicate findings to colleagues and cross-functional partners, and contribute to team activities and projects. The position is hybrid and based at the company’s Westbrook, Maine corporate headquarters, with at least three days onsite each week. Reliable and dependable attendance is an essential function of the position.

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 sound, evidence-based recommendations.
Strong documentation skills focused on accuracy, traceability, and compliance with Good Documentation Practices.
Strong verbal and written communication skills.
Ability to work independently and cooperatively as part of a team.
Organizational skills and ability to plan work and manage multiple priorities.
Initiative and accountability, focus on the task at hand, attention to detail, and adaptability.
Reliable and dependable attendance.

Nice To Haves

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

Responsibilities

Prepare materials and conduct immunoassay experiments; gather and analyze data and reach conclusions.
Lead design of experiments (DoEs).
Evaluate assay performance, including signal response, calibration, sensitivity, specificity, reproducibility, and lot-to-lot consistency, using JMP for statistical analysis, data visualization, and experimental design.
Recommend next steps based on experiment results and analysis.
Prepare and qualify assay components.
Produce and/or test reagents and final products and perform other production-related activities as needed.
Document experiments and laboratory or production activities in accordance with Good Documentation Practices.
Prepare reports and summaries, present results and conclusions, and maintain appropriate records.
Participate in teams and potentially manage teams by planning and organizing team activities.
Lead straightforward projects with small scopes.
Collaborate and communicate with Manufacturing, Quality Control, Quality Assurance, Product Support, and R&D colleagues to support investigations and change orders, exchange information, and ensure efficient processes.
Order and maintain equipment and the work area, including routine instrument maintenance and troubleshooting.
Provide guidance within areas of direct expertise and potentially coach or mentor less experienced colleagues.
Maintain knowledge of products, procedures, developments in the field and industry, and the regulatory environment.
Follow appropriate procedures and regulatory requirements.