Sr Validation Engineer, QA

Job ID
2020-2584
Category
Quality Assurance & Regulatory Affairs
Location : City
Madison

Job Description

Promega is an international bio-tech company with over 4000 high quality products that have been supporting science for over 40 years. We support scientists researching life and disease, pharma companies developing new treatments, forensic labs matching DNA from crime scenes and clinical labs running and confirming health tests - and that’s just the beginning. And yes, we have been extremely busy providing our technologies to support COVID-19 testing and research.

We strive to create an open, inviting and inclusive culture – we care about you as a person, not just a team member. We embrace the principles of emotional and social intelligence – which helps our employees improve relationships, manage stress and enhance connections. Establishing and maintaining relationships is part of the foundation of our culture - teams are more like family than co-workers.


Our campus speaks volumes. Headquartered in Madison, employees work in and around a campus with multiple buildings that are integrated into a natural setting with trails, ponds, woods and a restored prairie. Sustainability is important – we invest in energy efficiency and use renewable energy. Our culinary team offers top notch food to employees – including an onsite garden to supply fresh produce.  Check out our campus through this map, and learn more about our people and sustainable practices

 

OUR TEAM:
We are a passionate team of Scientific/Engineering professionals responsible for the Promega Validation program. This multidiscipline team manages Equipment Qualification, Method Validation and more.


YOUR ROLE:
You are our go-to for equipment qualification of equipment used to manufacture medical devices. You have a passion and demonstrated experience establishing procedures for validating equipment and
processes, evaluating risk and serve as our expert on all things validation related.


YOUR EXPERIENCE:
You have an extensive background in IVD/Medical device validation, including molecular method and process validation. Ideally your experience would include filling, packaging and other manufacturing equipment. You are a complex thinker and have the ability to communicate across all levels of the organization. Strong cross functional teamwork experience is desired.

 

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


ESSENTIAL DUTIES:


1. Work with the Manufacturing Support and Technology (MSAT) engineering and validation teams to produce resource estimates and schedules for the process validation tasks on new projects. Manage scheduled activities to ensure the successful completion of validation tasks.


2. Review validation master plans for validation projects.


3. Responsible for approval of process validation test procedures and acceptance criteria for process equipment and critical utilities validation protocols.


4. Assist validation lead in turnover of validated systems to process owners.


5. Implement and coordinate validation activities in support of Quality Systems Regulation (QSR) compliant manufacturing.


6. Establish procedures for validating equipment, processes, and Quality Control (QC) methods.


7. Create process maps for manufacturing and QC processes; utilize maps for validation planning


8. Assist Project Managers in developing the validation needs within project plans and identifying the resources required for successful implementation of validations.


9. Serve as process validation equipment qualification subject matter expert (SME) for Promega in the IVD (21 CFR Part 820) regulated industry.


10. Serve as technical resource for specification of equipment for automation projects.


11. Proactively maintain a working knowledge of current industry trends and developments in the validation field including equipment facilities and utilities.


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


OCCASIONAL DUTIES:


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.


MANDATORY QUALIFICATIONS:


1. BS in engineering, chemistry, biochemistry, or related science field.


2. 5 or more years of process validation development and execution experience in a manufacturing environment in a biotech, pharmaceutical, or IVD industry.


3. Strong interpersonal and communication skills.


PREFERRED QUALIFICATIONS:


1. Advanced degree in engineering related discipline.


2. Validation Engineer certification.


3. 3 or more years of process validation development and execution experience in a manufacturing environment in the medical device industry.


4. Experience implementing automated packaging equipment projects.


PHYSICAL REQUIREMENTS:


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 to suppliers, equipment vendors, trade shows, etc.

 


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.

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