R&D V&V Scientist

Idexx • Westbrook, ID

1d • $72,000

About The Position

IDEXX is looking to hire a Scientist to join the New Product Development Verification and Validation Team . In this role, you will verify that products being designed, developed, or changed are in compliance with product requirements, specifications, and Company and regulatory guidelines. Coordinate with design teams to create and document procedures to verify and validate products and processes. Standardize work activities across products and platforms. Define, design, and implement validation test plans, analyze results, and generate summary reports. Create validation schedules and coordinate execution efforts. Compile data for regulatory submissions. Collect and review validation data and generate exception reports as needed. Ensure validation efforts are conducted in an appropriate and timely manner. Communicate and present data to colleagues. What can you expect? Coordinates product development efforts (V&V) within overall integrated system framework encompassing complete range of sciences, engineering, manufacturing, marketing, customer and other essential inputs to ensure end products meet requirements and perform their intended functions. Defines test plans during the product development process so that the validation test plans are known in advance. Prepares materials, performs experiments, gathers data, carries out analysis and reaches conclusions. Documents experiments and other lab or production activities. Prepares reports and summaries. Presents results and conclusions. Maintains appropriate records. Communicates validation issues both to design teams and to other parts of the organization. Creates, executes and obtains approval for validation plans, protocols and final summary reports. Monitors projects and reports on validation activities, status and commitments. Tracks and communicates progress of work against milestones. Participates on and may manage teams, planning and organizing team activities. Orders and maintains equipment and work area. Collaborates and communicates with colleagues and others in related areas to provide work support, exchange information and ensure efficient processes. May produce and/or test reagents and final products and perform other production-related activities. Maintains knowledge of products and procedures, developments in the field and industry and regulatory environment. Adheres to appropriate procedures and regulatory requirements.

Requirements

• Bachelor's degree in the biological sciences with 5-7 years of experience or Master’s degree with 0-3 years of experience.
• Good understanding of life and biological sciences.
• Proficiency in MS Office (Excel, Word, Outlook, PowerPoint) required.
• Experience with diagnostic instrumentation development.
• Laboratory bench and instrumentation skills.
• Analytical and problem-solving skills.
• Strong initiative, flexibility, positive attitude, and the ability to function effectively in a highly collaborative team environment.
• Excellent verbal, technical writing, and interpersonal communication skills.
• Ability to maintain accurate and clear documentation.
• Good presentation skills.
• Ability to work independently with minimal supervision.
• Organizational skills and ability to plan work.
• Takes initiative and is accountable (shows ownership); focuses on task at hand; detail oriented.
• Adaptable.
• Ability to work well under pressure and handle the stress of deadlines.
• Ability to resolve conflicts and facilitate solutions.

Nice To Haves

• Experience with JMP is preferred

Responsibilities

• Verify that products being designed, developed, or changed are in compliance with product requirements, specifications, and Company and regulatory guidelines.
• Coordinate with design teams to create and document procedures to verify and validate products and processes.
• Standardize work activities across products and platforms.
• Define, design, and implement validation test plans, analyze results, and generate summary reports.
• Create validation schedules and coordinate execution efforts.
• Compile data for regulatory submissions.
• Collect and review validation data and generate exception reports as needed.
• Ensure validation efforts are conducted in an appropriate and timely manner.
• Communicate and present data to colleagues.
• Coordinates product development efforts (V&V) within overall integrated system framework encompassing complete range of sciences, engineering, manufacturing, marketing, customer and other essential inputs to ensure end products meet requirements and perform their intended functions.
• Defines test plans during the product development process so that the validation test plans are known in advance.
• Prepares materials, performs experiments, gathers data, carries out analysis and reaches conclusions.
• Documents experiments and other lab or production activities.
• Prepares reports and summaries.
• Presents results and conclusions.
• Maintains appropriate records.
• Communicates validation issues both to design teams and to other parts of the organization.
• Creates, executes and obtains approval for validation plans, protocols and final summary reports.
• Monitors projects and reports on validation activities, status and commitments.
• Tracks and communicates progress of work against milestones.
• Participates on and may manage teams, planning and organizing team activities.
• Orders and maintains equipment and work area.
• Collaborates and communicates with colleagues and others in related areas to provide work support, exchange information and ensure efficient processes.
• May produce and/or test reagents and final products and perform other production-related activities.
• Maintains knowledge of products and procedures, developments in the field and industry and regulatory environment.
• Adheres to appropriate procedures and regulatory requirements.

Benefits

• Salary range starting at $72,000 based on experience
• Opportunity for annual cash bonus
• Health / Dental / Vision Benefits Day-One
• 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

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 5,001-10,000 employees