Process Engineer - Engineering
Company: Disability Solutions
Location: Madison
Posted on: September 28, 2024
Job Description:
Engineer - Process EngineeringSummaryCatalent Biologics is a
fast-growing business within Catalent Pharma Solutions focused on
providing innovative technologies and solutions to help more and
better biologic treatments get to patients. The business includes
our proprietary GPEx cell line engineering platform, our new
state-of-the-art biomanufacturing facility in Madison, WI, and our
market-leading biologics analytical services in Kansas City, MO and
Research Triangle Park, NC, as well as SMARTag Antibody Drug
Conjugate technology in Emeryville, CA. Leveraging our growing
differentiated technology portfolio, world-class manufacturing
capability, and other integrated services across the Catalent
network, Catalent Biologics is positioned to drive significant
growth for Catalent.The Equipment Engineering group has oversight
of equipment lifecycle management inclusive of equipment design
(URS through qualification support and release), equipment updates
(design modifications via change management), and general equipment
support through troubleshooting, training, and continuous
improvement. This function also maintains ownership of the capital
expenditure (CapEx) process.--------------------The Process
Engineering group has oversight of consumable and raw material
lifecycle management inclusive of process function definition,
design through drawing approval, onboarding support, and change
management. This function ensures integration of consumables with
equipment and associated manufacturing processes, while maintaining
larger strategy project ownership across the facility (e.g.,
equipment methods, risk assessments, control strategies, etc.).This
is a full-time on-site position, Monday - Friday
8am-5:00pm.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:
- Evaluate existing processes and identifies process or equipment
improvements to advance efficiency, cost savings, time savings,
consistency, and competitiveness within the market.
- Support the building of business case(s) for process
improvement projects.
- Author and review documents including bill of materials,
process descriptions, project reports, engineering specifications,
and summary reports.
- Act as the lead for technical support of risk assessments, gap
analysis, deviations, change controls, and CAPAs including
determination of product or process impact, root-cause analysis,
and corrective action identification.
- Support drafting and development of User Required
Specifications, support and attend Factory Acceptance Testing, Site
Acceptance Testing, Qualification/Validation testing for existing
and new technologies.
- Lead site strategy projects with dedicated cross-department
resources with Site Leadership (SLT) visibility through
implementation.
- Oversee technical support of Manufacturing, including change
management (consumable lifecycle integration with site equipment,
raw materials), SME troubleshooting, and leading or providing
oversight on site strategy projects.
- Work alongside a group of engineers, scientists, and other
colleagues to oversee the process engineering function associated
with mammalian biologic processes, mRNA, and other new modality
manufacturing.
- Support biologics/molecular therapeutics drug substance
consumable and raw material lifecycle management from
identification and/or design through implementation for single-use
GMP manufacturing (fit for process use).
- Track, trend, and analyze data for compliance, product quality,
continuous improvement, and day-to-day
investigations/troubleshooting activities.
- Other duties as assigned.The Candidate:
- Minimum B.S. degree in Industrial, Electrical, Mechanical,
Chemical, Computer Science, Civil Engineering, or related
scientific/engineering field with 3+ years' facilities
operation/automation engineering experience in a cGMP environment
(preferably biopharmaceutical) OR
- M.S. degree in Industrial, Electrical, Mechanical, Chemical,
Computer Science, Civil Engineering, or related
scientific/engineering field with 1+ years' facilities
operation/automation engineering experience in a cGMP environment
(preferably biopharmaceutical)----
- Previous experience leading cross-department facility and/or
site improvement projects, a plus
- Problem-solving (Lean Six Sigma) and change management
methodologies consistent with a culture of continuous improvement
is preferred
- Must be proficient in operation and troubleshooting of a wide
variety of instrumentation and data systems
- Ability to provide ideas, introduce new technology, and drive
process improvements. Work with other groups to develop, qualify,
and transfer methods accordingly
- Ability to cross-train on techniques across multiple
groups.
- Experience writing, editing, and reviewing Standard Operating
Procedures preferredPhysical Requirements:
- Frequent sitting, standing, walking, reading of written
documents and use of computer monitor screen, reaching with hands
and arms, talking, writing, listening.
- Occasional stooping, kneeling, crouching, bending, carrying,
grasping.
- Frequent lifting and/or moving up to 10 pounds and occasional
lifting and/or moving up to 50 pounds.
- Must comply with EHS responsibilities for the position.
- Working conditions will be Heating Ventilation and Air
Conditioned controlled.
- Ability to operate within a clean room environment as
needed.Why you should join Catalent:
- 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--Catalent offers rewarding opportunities
to further your career!-- Join the global drug development and
delivery leader and help us bring over 7,000 life-saving and
life-enhancing products to patients around the world. Catalent is
an exciting and growing international company where employees work
directly with pharma, biopharma and consumer health companies of
all sizes to advance new medicines from early development to
clinical trials and to the market. Catalent produces more than 70
billion doses per year, and each one will be used by someone who is
counting on us. Join us in making a difference.--personal
initiative. dynamic pace. meaningful work.Visit to explore career
opportunities.Catalent is an Equal Opportunity Employer, including
disability and veterans.If you require reasonable accommodation for
any part of the application or hiring process due to a disability,
you may submit your request by sending an email, and confirming
your request for an accommodation and include the job number, title
and location to . This option is reserved for individuals who
require accommodation due to a disability. Information received
will be processed by a U.S. Catalent employee and then routed to a
local recruiter who will provide assistance to ensure appropriate
consideration in the application or hiring process.--------Notice
to Agency and Search Firm Representatives: Catalent Pharma
Solutions (Catalent) is not accepting unsolicited resumes from
agencies and/or search firms for this job posting. Resumes
submitted to any Catalent employee by a third party agency and/or
search firm without a valid written & signed search agreement, will
become the sole property of Catalent. No fee will be paid if a
candidate is hired for this position as a result of an unsolicited
agency or search firm referral. Thank you.Important Security Notice
to U.S. Job Seekers:Catalent NEVER asks candidates to provide any
type of payment, bank details, photocopies of identification,
social security number or other highly sensitive personal
information during the offer process, and we NEVER do so via email
or social media. If you receive any such request, DO NOT respond-
it is a fraudulent request. Please forward such requests to
spam@catalent.com for us to investigate with local
authorities.California Job Seekers can find our California Job
Applicant Notice .
Keywords: Disability Solutions, Madison , Process Engineer - Engineering, Engineering , Madison, Wisconsin
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