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Senior Validation Engineer, QA - Equipment Qualification / Method Validation

  • Location: Madison, Wisconsin
  • Type: Direct Hire
  • Job #2816

Are you highly skilled in Equipment Qualification, Method Validation, and overall QA Validation and looking to take your next big career step? We have a great team of Engineers and Scientists that are waiting to meet you!
 

What You'll Do:
You are our Quality 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.

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.

Essential Duties:

This role will be responsible for managing and performing the Process Validation activities for all manufacturing equipment, manufacturing processes, and critical utilities. This includes:

– 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.

– Review validation master plans for validation projects.

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

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

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

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

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

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

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

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

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

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

– Embracing and being open to incorporating the company's core principles in daily work.

– Understand and comply with ethical, legal, and regulatory requirements applicable to the business.

OCCASIONAL DUTIES:

– Provide support to management for special projects or duties.

– Present updates and departmental information at various company meetings.

– Attend relevant validation meetings and technical seminars.

What You'll Bring:

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

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

– Strong interpersonal and communication skills.

PREFERRED QUALIFICATIONS:

– Advanced degree in engineering related discipline.

– Validation Engineer certification.

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

– Experience implementing automated packaging equipment projects.

PHYSICAL DEMANDS:

– Ability to observe and inspect equipment and operations for proper operation and compliance to safety and housekeeping standards.

– Ability to work in a production environment around automated equipment.

– Ability to work in an office environment utilizing a computer workstation.

– Ability to work in a lab environment with chemical, biological, and packaging materials.

– Ability to travel by car or airplane to suppliers, equipment vendors, trade shows, etc.

 

Apply Now and move your career forward with an exciting and highly respected biotech leader!
Questions? Contact Ginger Auchter directly at Ginger@CarexScientific.com

 

Carex Consulting Group is an equal opportunity employer. We are committed to equal employment opportunity regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, marital status, disability, gender identity or Veteran status.

 

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