Engineer Process, QC and Calibration Process Development

IDEXX Laboratories, Inc; Westbrook (ME); Hybride; USD 93 000 - 98 000; Plein temps

Avantages offerts par ce poste

Health benefits day one

Annual cash bonus

401k with match

Employee stock program

Pet insurance

Mental health resources

Résumé du poste

IDEXX Laboratories, Inc. in Westbrook, Maine seeks a Process Engineer II focused on QC and Calibration Process Development.

You will support development, qualification, and continuous improvement of the quality control and calibration processes for immunoassay and PCR-based assays, reagents, and manufacturing processes. The role includes leading DoEs, analyzing data with JMP, documenting activities, and collaborating with Manufacturing, Quality Control, QA and R&D.

Qualifications

• Hands-on experience with immunoassay techniques and assay troubleshooting.
• Experience with ELISA and reagent preparation is preferred.
• Strong documentation and data analysis skills, including JMP.
• Ability to design and run experiments and interpret results.

Responsabilités

• Prepares materials, performs immunoassay experiments, gathers data and leads DoEs.
• Evaluates assay performance and calibration using JMP for analysis and design of experiments.
• Prepares and qualifies assay components and maintains records per Good Documentation Practices.
• Collaborates with Manufacturing, Quality Control, QA, Product Support and R&D.
• Maintains equipment and instruments, troubleshoots issues and provides guidance.

Connaissances

Immunoassay techniques

ELISA

Reagent preparation

Assay troubleshooting

Statistical analysis

Outils

JMP

JSL scripting

Description du poste

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 ratetargeting $93,000 - 98,000 annually (based on experience)
• Opportunity for performance based annual merit increase
• Health/Dental/VisionBenefitsavailable dayoneof employment
• Opportunity for annualcashbonus
• 5% matching 401k
• Additional benefitsincluding but not limited to financial support, pet insurance, mentalhealth resources, volunteer paid days off, employee stock program, foundation donationmatching, 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.