Analytical Method Validation Scientist Promega
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JOB OBJECTIVE: Manage and Perform Analytical Method Validation activities for all methods supporting US-IVD products.
1. Work with the Manufacturing, Quality Control, Quality Assurance, Research and Development and the Team to produce resource estimates and schedules for analytical method validation tasks on new projects. Manage schedule activities for successful completion of validation tasks.
2. Create Validation Master Plans for analytical method validation projects where appropriate.
3. Responsible for preparation and execution of analytical method validation test procedures and acceptance criteria for validation protocols.
4. Assist Validation Lead in turnover of validated methods to process owners.
5. Supervision ? Supervise validation contract personnel in planning and completion of analytical method validation tasks.
6. Project Management ? Assist Project Managers in developing the validation planning portions of project plans, and in scoping the resources required for successful implementation of validation.
7. Serve as an analytical method validation expert resource for Promega in the IVD (21 CFR Part 820) regulated industry.
8. Serve as technical resource for specification of method equipment.
9. Proactively maintain working knowledge of current industry trends and developments in the computer-related information systems validation field.
10. Understands and complies with ethical, legal and regulatory requirements applicable to our business.
1. Provide support to Management for special projects or duties.
2. Present updates and departmental information at various company meetings.
3. Attend relevant validation meetings and technical seminars.
1. BS in biological sciences such as Microbiology, Molecular Biology or Genetics or related engineering discipline.
2. Two or more years of analytical method validation development and execution experience in a manufacturing environment in the biotech, pharmaceutical, or IVD industry.
3. Strong interpersonal and communication skills.
1. Advanced Degree (M.S. or PhD) in biological sciences.
2. Certification as a Validation Engineer.
3. Two or more years of analytical method validation development and execution experience in a manufacturing environment in the Medical Device industry.
4. Experience implementing automated packaging equipment projects.
1. Ability to observe and inspect equipment and operations for proper operation and compliance to safety and housekeeping standards.
2. Ability to work in a production environment around automated equipment.
3. Ability to work in an office environment utilizing a computer workstation.
4. Ability to work in a lab environment with chemical, biological and packaging materials.
5. Ability to travel by car or airplane, for one or several days, to suppliers, equipment vendors, trade shows, etc.
Promega Corporation is an Affirmative Action/Equal Opportunity Employer.
Madison, Wisconsin, United States
||2800 Woods Hollow Road |
Madison, WI 53711
THIS JOB HAS EXPIRED