Principal Process Engineer - Manufacturing Sciences & Technology, Upstream
Company: Disability Solutions
Location: Madison
Posted on: May 3, 2024
Job Description:
Principal Process Engineer - Manufacturing Sciences &
Technology, UpstreamSummaryCatalent 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.Working for Catalent Biologics is an
opportunity to join an entrepreneurial team.-- Catalent Biologics
is making significant investments in people and capabilities.--
This is a unique opening to join a small, fast growing business,
backed by a global public company.-- People joining our team will
have the opportunity for career development as our business
continues to grow and expand.-- Catalent-Madison employees are
helping to improve future patient outcomes by working on products
that are designed to treat cancer, various autoimmune, fibrotic and
blood disorders, HIV, diabetes, heart and lung diseases as well as
Alzheimer's.The Manufacturing Science and Technology subject matter
expert will oversee technical support of Manufacturing, including
the technology transfer between external clients or Process
Development and Manufacturing.The position will work alongside a
group of engineers, scientists and other colleagues to drive the
facility fit and technical transfer of mammalian biologic
processes.-- The position will also include responsibilities
associated with the evaluation, alignment and recommendation of
equipment and process improvements.-- This role will direct on-call
and on-the-floor technical support to manufacturing. The SME will
be responsible for the drafting and review of documentation,
compilation and assessment of process data, and provide technical
input for deviations investigations, change controls, and CAPAs.
This position will be client facing and should possess the ability
to work collaboratively with clients and internal cross-functional
stakeholders to move projects forward.This is a full-time on-site
position, Monday - Friday 8am-4:30pmCatalent 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.
- Participates in and supports strategic alignment across
Catalent Biologics sites and the Madison site.
- 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.
- Evaluates existing processes and identifies process or
equipment improvements to advance efficiency, consistency, and
competitiveness within the market.
- Supports the building of business case(s) for process
improvement projects
- 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.
- Responsible for motivating, coaching and developing coworkers
as a subject matter expert.
- Perform other responsibilities to support group, site and
network-based initiatives, as required.
- Other duties as assigned.The Candidate
- PhD in Engineering, Biotechnology, or related field, with
minimum of 8 years of relevant experience; OR
- M.S./M.A. in Engineering, Biotechnology, or related field, with
minimum of 12 years of relevant experience; OR
- B.S./B.A. in Engineering, Biotechnology, or related field, with
minimum of 15 years of relevant experience.
- Experience with Upstream (mammalian cell culture) processes
across cGMP biologics production scales.
- Experience in facility fit, process scaling and technology
transfer.
- Experience in writing reports and documentation skills such as
drafting and revising standard operating procedures, batch
production records.
- Direct personnel and organizational group management
experience, including mentoring and training staff members
cross-functionally.
- Experience drafting and revising standard operating procedures,
batch production records and reports.
- Demonstrated working knowledge of Tech Transfer between
Development and Manufacturing.
- Demonstrated understanding of multiple applicable techniques,
including purification, buffer preparation, operation and
troubleshooting of stirred vessel bioreactors, incubators,
chromatography columns and processing, and filtration
apparatuses.Physical 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 in a lab environment will require working with skin
irritants, lung irritants, electrical equipment, sharp instruments,
toxic materials, and hazardous waste. Safety procedures must be
followed to minimize exposure, including proper use of PPE
(personal protective equipment) and clean room gowning.
- Working conditions will be Heating Ventilation and Air
Conditioned controlled.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.--Catalent is
committed to the health and safety of its employees, visitors and
the customers and patients we serve. As a result of the global
pandemic, we have modified many of our recruitment and on-boarding
processes to maintain everyone's safety. The Human Resources teams
will communicate all necessary safety processes and procedures
throughout each stage.------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, Rockford , Principal Process Engineer - Manufacturing Sciences & Technology, Upstream, IT / Software / Systems , Madison, Illinois
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