Job Opening: Sr Process Validation Engineer
- Company
- PROMEGA CORPORATION
- Location
- MADISON, WI
- Posted on
- May 10, 2024
JOB REQUIREMENTS: Job Description 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... For full info follow application link.
Diversity is important at Promega. We are proud to be an Equal
Opportunity Employer, and make employment decisions without regard to
race, color, religion, sex, sexual orientation, gender identity,
national origin, veteran status, disability, or any other protected
class. ***** APPLICATION INSTRUCTIONS: Apply Online:
ipc.us/t/825A62F6E3274B8C Qualified females, minorities, and special
disabled veterans and other veterans are encouraged to apply.