Process Engineer, MS&T
Company: Disability Solutions
Location: Princeton
Posted on: October 25, 2024
Job Description:
Process Engineer, MS&T Position Summary:Catalent Pharma
Solutions in Princeton, NJ is hiring a Manufacturing Science and
Technology (MSAT) Process Engineer who provides technical support
to Princeton, NJ Facility (CPNJ) Manufacturing processes in a GMP
environment. Technical support includes troubleshooting process and
equipment related issues that occur during the Manufacturing
process. The MSAT Process Engineer works closely with the
Manufacturing and Quality teams to determine immediate corrective
actions for deviations, identifies root cause, and implements
long-term preventive actions. Other responsibilities include
participation in process tech transfer and incoming process
changes, communicate the changes to applicable departments, and
lead the process improvement projects at the site. The MSAT process
engineer works to identify and drive continuous improvements to the
manufacturing processThis is a full-time role position: Monday -
Friday, days.Catalent is a global, high-growth, public company and
a leading partner for the pharmaceutical industry in the
development and manufacturing of new treatments for patients
worldwide. Your talents, ideas, and passion are essential to our
mission: to help people live better, healthier lives.--Our U.S.
commercial cell therapy manufacturing facility is located in
Princeton, NJ, and is part of Catalent's cell therapy network
including our European Center of Excellence for cell therapy in
Gosselies, Belgium. The CGMP manufacturing facility is equipped
with 16 flexible clean rooms, QC labs, and warehouse space to
support late-stage and commercial-scale autologous and allogeneic
cell therapy productionCatalent 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
- Functions as a technology and process subject matter
expert;
- Provides on-the-floor and on-site technical support to
manufacturing when necessary;
- Author, review and approve, as needed, various documents (eg.
Batch records, SOPs);
- Author, and approve protocol and reports in accordance with
internal and external regulatory expectations (APS, Engineering,
Tech Transfer);
- Analyze and summarize manufacturing data to support impact
assessments and investigations;
- Owner of change controls for process and procedure changes.
Lead and executes CAPA system investigations;
- Leads technology transfer efforts for new processes and product
implementation. Performs tech transfer facility fitness, gap
analysis, and risk assessment when on-boarding new programs.
- Applies continuous improvement tools to identify and close
procedural and compliance gaps;
- Identify opportunities for process improvements and operational
efficiencies, and lead implementation efforts'
- Represent MSAT and interface with other functions such as
Process Development, Supply Chain, Quality, Validation, and
Facilities & Engineering;
- Support equipment and systems validation activities, including
review of equipment qualification documents, drafting user
requirement specifications, and participating on impact
assessments;
- All other duties as assigned;The Candidate
- Bachelors and/or Advanced degree required in Science or
Chemical/Biological Engineering with 5+ years of industry
experience required;
- 3+ years relevant experience in GMP biologic/cell therapy
manufacturing technical or process support;
- Scientific understanding in bioprocessing principles.
Familiarity with cell therapy processes and cGMP is strongly
preferred;
- Experience in process qualification and validation
required;
- Experience with the start-up, validation, and licensure of new
biopharmaceutical manufacturing facilities is preferred;
- Experience with program management software and tools
preferred;
- Experience working with external parties and/or
cross-functional teams
- Ability to think strategically and to translate strategy into
actions
- Individual may be required to sit, stand, walk regularly and
occasionally lift 0-15 pounds;Why you should join Catalent:
- Defined career path and annual performance review and feedback
process--
- Diverse, inclusive culture--
- 152 Hours PTO + 8 paid holidays
- Several Employee Resource Groups focusing on D&I
- Dynamic, fast-paced work environment
- Employee Stock Purchase Program
- Positive working environment focusing on continually improving
processes to remain innovative
- Potential for career growth on an expanding team within an
organization dedicated to preserving and bettering lives--
- Competitive salary with 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--- Let us help you finish your degree or
earn a new one!
- GymPass program to promote overall physical wellness--
- Perkspot - offers exclusive or private discounts from
approximately 900+ merchants in a wide array of categoriesCatalent
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, Hamilton , Process Engineer, MS&T, Engineering , Princeton, New Jersey
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