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Process Validation Engineer (Biotech, Pharma or Similar Background) Madison, WI

  • Location: Madison, Wisconsin
  • Type: Direct Hire
  • Job #2819

Are you a Process Validation Engineer with Process Validation Development and Execution experience within a Biotech, Pharma or similar manufacturing environment? If you're looking to join a leading Biotech company in the Madison area with a great team and lots of room for growth, this opportunity is for you!

What You'll Do:
This role is a key part of the Operations Validation Team. The team is made up of different specialists who play multiple roles including statistical data scientists, process validation engineers, and analytical method validation engineers that provide their expertise in all things Validation. This includes validating products, processes, analytical methods, and qualifying equipment that supports the Class 1 Medical Devices. The diverse internal clientele includes all areas of the company's Bulk Manufacturing, Customs Manufacturing and R&D business units.

In this role you'll have an opportunity to 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. Additional key responsibilities include:

  • Perform the Process Validation activities for all manufacturing equipment, manufacturing processes, and critical utilities.
  • Work with the Engineering lead 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.
  • Assist in creating Validation Master Plans for process validation projects.
  • Responsible for preparation and execution of process validation test procedures and acceptance criteria for process equipment and critical utilities validation protocols.
  • Work directly with equipment vendors to assist them in development of process design and validation documentation, and in facilitating review/approvals within the company.
  • Assist Validation Lead in turnover of validated systems to process owners.
  • 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.
  • Serve as process validation expert resource 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 working knowledge of current industry trends and developments in the process validation field.
  • 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.
  • Demonstrates inclusion through their own words and actions and is accountable for a safe workspace. Acts with kindness, curiosity and respect for others.
  • Understands and complies with ethical, legal and regulatory requirements applicable to our business.

What You'll Bring:

  • BS in Mechanical Engineering, or related Engineering discipline.
  • Two or more years of process validation development and execution experience in a manufacturing environment in the biotech, pharmaceutical, or IVD industry.
  • Strong interpersonal and communication skills.

PREFERRED QUALIFICATIONS (We encourage you to apply even if you do not have the following):

  • Advanced Degree (M.S. or PhD) in Engineering related discipline.
  • Certification as a Validation Engineer.
  • Two 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.

ADDITIONAL NEEDS OF ROLE:

  • 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, for one or several days, to suppliers, equipment vendors, trade shows, etc.

 

Take the next big step in your career and Apply Now!
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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