OUR TEAM: We are the Operations Validation Team. We are made up of different specialists who play multiple roles: statistical data scientists, process validation engineers, analytical method validation engineers. We provide our expertise in all things Validation to Promega. We lend our expertise to validating products, processes, analytical methods, and qualifying equipment that supports our Class 1 Medical Devices. Our diverse internal clientele includes all areas of Promega's Bulk Manufacturing, Customs Manufacturing and R&D business units.

YOUR ROLE: Lead and execute validation and qualification activities of equipment and processes while working in a team environment. Independently draft, review, execute validation and qualification protocols per industry practices and internal guidelines. The position requires working knowledge and experience in the qualification of bulk manufacturing process equipment and facilities utilities. Experience with equipment and process validation is highly desirable.

JOB OBJECTIVE: Manage and Perform the Process Validation activities for all manufacturing equipment, manufacturing processes, facilities and critical utilities.

CORE DUTIES:

1. Work independently and collaboratively. Characterize process performance as needed. Develop validation procedures. Guide the determination of acceptance criteria for validation and qualification protocols.

2. Work with the Operations, Engineering, and Validation Team to produce resource estimates and schedules for the process validation tasks on projects. Manage schedule activities for successful completion of validation tasks. Assist Project Managers in developing the validation planning portions of project plans, and in scoping the resources required for successful implementation of validation tasks.

3. Create or revise Validation Master Plans and other Validation planning documents where appropriate.

4. Responsible for preparation and execution of process validation test procedures and acceptance criteria for process equipment, facilities, and critical utilities validation protocols.

5. Work directly with equipment vendors to assist them in development of process design and validation documentation, and in facilitating review/approvals within Promega.

6. Serve as or assist Validation Lead in turnover of validated systems to process owners. Evaluate and support changes to validated systems.

7. Supervise validation contract personnel in planning and completion of process validation tasks.

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. Demonstrates inclusion through their own words and actions and is accountable for a safe workspace. Acts with kindness, curiosity and respect for others.

12. Embracing and being open to incorporating Promega's 6 Emotional & Social Intelligence (ESI) core principles in daily work.

13. Understands and complies with ethical, legal and regulatory requirements applicable to our business.

KEY QUALIFICATIONS:

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, IVD or Medical Device industry.

3. Five or more years of experience analyzing data for complex problems and communicating the problem, the meaning of the data, and any potential solutions to stakeholders at various levels and degrees of technical knowledge.

4. Strong interpersonal and communication skills.

PREFERRED QUALIFICATIONS:

1. Advanced Degree (M.S. or PhD) in Engineering related discipline.

2. Certification as a Validation Engineer.

3. Ten or more years of process validation development and execution experience in a manufacturing environment in the Biotech, Pharmaceutical, IVD or Medical Device industry.

4. Ten or more years of experience analyzing data for complex problems and communicating the problem, the meaning of the data, and any potential solutions to stakeholders at various levels and degrees of technical knowledge.

5. Experience implementing automated packaging equipment projects.

PHYSICAL DEMANDS:

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 transport items between buildings.

6. Ability to use a computer/Microsoft Office applications.

7. Ability to travel by car or airplane, for one or several days, to suppliers, equipment vendors, trade shows, etc.

At Promega, we value diversity and strive to create an inclusive workplace. We are proud to be an Equal Opportunity Employer, making employment decisions without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran status, disability, or any other protected class.