Senior Process Engineer - Manufacturing Science & Technology
Company: Disability Solutions
Location: Madison
Posted on: September 28, 2024
Job Description:
Senior Process Engineer - MS&T Operational Engineering
Wednesday to Saturday 2nd shift-- SummaryCatalent 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.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.The Manufacturing Sciences and Technology
(MS&T) department's primary function is to serve as an agile
technical services team to support process & technology transfer
(e.g., mAbs, fusion proteins, enzymes, mRNA, new modalities, etc.),
process readiness and execution support related to documentation,
equipment, consumables and materials, and technical writing.-- The
MS&T organization supports the Madison facility as well as the
Catalent Biologic's network through client-facing support,
on-the-floor or on-call technical coverage, as well as continuous
improvement and site strategy projects.The Operational Engineering
group primary function is to provide technical support for the
manufacturing execution team.-- This includes on the floor or
on-call support during execution.-- The team will be the subject
matter experts on the manufacturing process and equipment and
provide input in the design of consumables and batch records/SOPs
to support operational success.---- This is a full-time role
working Wednesday to Saturday 2nd shift (2pm-1am)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:
- Support technology transfer of processes into manufacturing for
both internally and externally developed processes.
- Works cross-functionally with Process Development,
Manufacturing, Quality Assurance, Quality Control, Supply Chain,
Project Management, Facilities and other departments to effectively
transfer and maintain processes in the facility.
- Works closely with manufacturing to author appropriate batch
documentation and provide technical and strategic oversight
associated with GMP manufacturing.
- Leads and/or supports the compilation of process data,
including communicating project status, trend identification, and
delivering internal or client presentations.
- Evaluate existing processes and identify process or equipment
improvements to advance efficiency, consistency, and
competitiveness within the market.
- Authors and reviews documents including batch production
records, tech transfer reports, bill of materials, process
descriptions, project reports, engineering specifications, and
summary reports.
- Acts 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.
- Other duties as assigned.The Candidate:
- Doctorate degree in a STEM discipline with 0-2 years of related
experience
- MS. in engineering, biotechnology, or a related field with 4+
years of biopharmaceutical process development and/or manufacturing
experience
- BS/BA in engineering, biotechnology, or a related field with 6+
years of biopharmaceutical process development and/or manufacturing
experience
- Associate degree in a related field with 12+ years of
biopharmaceutical process development and manufacturing
experience
- Experience with Upstream (mammalian cell culture), Downstream
(chromatography, tangential flow filtration, etc.) and/or molecular
therapeutics (mRNA or new modality) processes across cGMP
production scales
- Experience with design, onboarding, qualification and
troubleshooting biologics/molecular therapeutics single-use
consumables and/or manufacturing equipment
- Advanced in core techniques. Advanced understanding of
instrument operations and troubleshooting skills in multiple
techniques.
- Strong technical knowledge and hands-on experience with
biological manufacturing and validation concepts and procedures in
a GMP environment.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
- 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 , Senior Process Engineer - Manufacturing Science & Technology, Engineering , Madison, Wisconsin
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