Sr. Process Validation Engineer Promega
JOB OBJECTIVE: Manage and perform the Process Validation activities for all manufacturing facilities, equipment, processes, and critical utilities.
1. Work with the Operations Engineering and validation Team to produce resource estimates and schedules for the process validation tasks on new projects. Manage schedule activities for successful completion of validation tasks.
2. Create Validation Master Plans for process validation projects.
3. Responsible for preparation and execution of process validation test procedures and acceptance criteria for process equipment and critical utilities validation protocols.
4. Work directly with equipment vendors to assist them in development of process design and validation documentation, and in facilitating review/approvals within Promega.
5. Assist Validation Lead in turnover of validated systems to process owners.
6. Supervision ? Supervise validation contract personnel in planning and completion of process validation tasks.
7. 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.
8. Serve as process validation expert resource for Promega in the IVD (21 CFR Part 820) regulated industry.
9. Serve as technical resource for specification of equipment for automation projects.
10. Proactively maintain working knowledge of current industry trends and developments in the process validation field.
11. 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 Mechanical Engineering, or related Engineering discipline.
2. Five or more years of process validation development and execution experience in a manufacturing environment in the biotech, pharmaceutical, or IVD industry.
3. Five or more years of progressive experience in equipment utilities and facility qualification.
4. Strong interpersonal and communication skills.
5. Strong computer skills including Microsoft Office.
1. Experience in an ISO 13485, FDA GMP or USDA regulated environment.
2. Experience with GMP Water System Qualification.
3. Experience with HVAC/Facility Qualification.
4. Experience with HMI/APC Validation.
5. Advanced Degree (M.S. or PhD) in Engineering related discipline.
6. Certification as a Validation Engineer.
7. Two or more years of process validation development and execution experience in a manufacturing environment in the Medical Device industry.
8. 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