Process Engineer, Manufacturing Sciences

at Catalent
Location Madison, Wisconsin
Date Posted July 19, 2021
Category Bioscience
Job Type Full-time
Address 726 Heartland Trail, Suite 100

Description

Position Overview: 

Catalent hires people with a passion to make a difference to the health of millions of people globally. Your expertise, coupled with Catalent’s advanced technologies and collaboration with thousands of innovative pharmaceutical, biotech and healthcare companies, will help bring life-enhancing products to the people you know and love.  Your talents, ideas and passion are essential to our mission; to develop, manufacture and supply products that help people live better, healthier lives. Interested in learning more about life at Catalent? Start here

 

Process Engineer, Manufacturing Sciences

This position will be part of the Manufacturing Sciences group tasked with supporting the transfer, execution and monitoring of mammalian cell culture and purification processes in our manufacturing suites. This position will support the site’s strategic plan by working with Consultants, Manufacturing and Quality personnel to manage the deliverables required to prepare the Madison, WI site for Phase III/Commercial manufacturing. The Process Engineer will support the facility and its teams to drive the closure of process and equipment gaps.  This position will evaluate and develop the documentation necessary to specify, purchase, install and commission new equipment and custom disposable consumables, as well as evaluate existing equipment for uniformity between Process Development and Manufacturing.

This is a permanent, full time position.  It is a salaried role. This position is a first shift Monday-Friday 8a-5p role.

Our new, state of the art Madison, WI facility, with expanded mammalian cell line engineering and biomanufacturing capabilities utilizing single-use systems, offers increased flexibility and manufacturing scale to support our customers’ growth. We offer a broad range of integrated formulation and analytical services to solve your most difficult development challenges in Biologics.

Catalent is committed to a Patient First culture through excellence in quality and compliance, and to the safety of every patient, consumer and Catalent employee.

The Role:

  • Supports batch production records drafting and review for process development and manufacturing
  • Works with stakeholders on implementation plans and experimentation between development and manufacturing, including development of quality and business attributes for equipment
  • Drafts required documents for the design and purchase of new equipment and custom disposables
  • Contributes to the design of new equipment and validation procedures
  • Applies technical and functional knowledge to job related duties on most projects/ assignments within own group or project team
  • Provides support to investigations due to potential equipment or process failures
  • Provides on the floor support for process development and manufacturing runs
  • Establishes and maintains working understanding of Process Development and Manufacturing equipment

The Candidate:

Education:

  • MS in Biotechnology, Engineering, the Life Sciences or a related technical discipline with 0 to 2 years of biopharmaceutical process development and manufacturing experience
  • B.S/B.A. in Biotechnology, Engineering, the Life Sciences or a related technical discipline with at least 3-6 years of biopharmaceutical process development and manufacturing experience
  • 1+ years of relevant work experience in a current Good Manufacturing Practices (cGMP) environment with progressive responsibilities

Experience:

  • Knowledge of current Good Manufacturing Practices (cGMP) environment
  • Lab experience including engineering based design or experimentation
  • Leadership experience for cross functional teams
  • Knowledge of mRNA processing preferred
  • Knowledge of Cleaning Validation/Verification preferred

Catalent Benefits:

  • Defined career path and annual performance review and feedback process
  • Diverse, inclusive culture
  • Potential for career growth on an expanding team within an organization dedicated to preserving and bettering lives
  • 152 hours of paid time off annually + 8 paid holidays
  • Competitive salary with yearly bonus potential
  • Community engagement and green initiatives
  • Generous 401K match and Paid Time Off accrual
  • Medical, dental and vision benefits effective day one of employment
  • Tuition Reimbursement
  • On-site fitness center and wellness programs

Catalent’s standard leadership competencies that are used to interview and for Performance & Development:

  • Leads with Integrity and Respect
  • Delivers Results
  • Demonstrates Business Acumen
  • Fosters Collaboration and Teamwork
  • Champions Change
  • Engages and Inspires
  • Coaches and Develops

 

Click here to learn more & apply today!