Senior Engineer - Process Engineering
Company: Disability Solutions
Location: Bloomington
Posted on: May 4, 2024
Job Description:
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.--Catalent is hiring a Senior
Process Engineer responsible for supporting cGMP operations and
becoming an expert in their field; knowledgeable of
automation/controls associated with manufacturing and support
equipment; able to seamlessly work cross-functionally to provide
unified engineering support to the manufacturing group. Works as an
industry expert to create design specifications, P&ID drawings,
general arrangement drawings, user requirements, functional
specifications, and automation control strategies. Provides
technical solutions to complex problems by relying upon their
experience and/or seeking recommendations from industry experts.
Understands and applies the concepts of the manufacturing area
supported.--Develops processes to minimize risks and is very
familiar with change management in a cGMP environment.The Senior
Process Engineer will support ongoing Drug Substance manufacturing
activities by being system owner of process equipment, including
large and critical bioprocessing assets. They will be assisting in
troubleshooting complex mechanical problems, identifying
improvements in process equipment to enhance safety, prevent
quality and compliance issues, minimize downtime, and reduce
operational costs. They will also support new and ongoing capital
expenditure (capex) projects by managing and planning project
schedules and budgets as well as providing contractor
oversight.--This position will assist in identifying, tracking,
forecasting, and implementing capex projects by working with site
leadership and departmental end-users to identify the correct
project parameters and requirements.Catalent in Bloomington,
Indiana is a state-of-the-art, cGMP manufacturing facility,
providing one million sqft of drug substance manufacturing, drug
product manufacturing, and related pharmaceutical services. This
award-winning facility helps customers accelerate biologic drug
development programs and bring better treatments to help patients
live better healthier lives.--This is a fulltime position working
days; Monday - FridayThis role offers a sign on bonus of
$10,000Catalent 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 Drug Substance manufacturing and engineering operations
and act as subject matter expert within their scope of
responsibility
- Has knowledge of the principles, theories, and concepts
applicable to a wide range of process engineering work
- Applies technical and functional knowledge on a broad range of
difficult problems to enable department/group/team to meet
goals
- Recommend improvements to meet OSHA, ISPE, and FDA guidelines
as well as industry best practices
- Maintain project compliance in accordance with the site quality
management system--
- Review and execute changes to validated production systems
through the change control program
- Assist in responding to customer and regulatory audit
observations and corrective actions
- Create and maintain all aspects of equipment design files
- Provide engineering guidance and execution on equipment and
automation projects
- Identify and implement improvement opportunities for
established production systems
- Guide the specification and selection of manufacturing
equipment to support site process needs--
- Develop standard processes to evaluate future capital
projects--
- Contribute to the creation of maintenance and calibration
procedures and update existing procedures to match best practices
and lessons learned
- Perform hands-on activities as needed to help troubleshoot
problems and support staff--
- Evaluate systems for obsoletion and updates to meet future
operations
- Competent at risk mitigation for function
- Collaborate significantly with cross-functional groups
including Manufacturing, Validation, Quality Assurance,
Facilities
- Provide direction and mentor other team members
- Provide technical assistance and training for personnel
- Other duties as assignedThe Candidate:
- Bachelor's degree in Chemical/Mechanical/Electrical Engineering
or appropriate scientific discipline, required----
- Master's degree, preferred--
- PE / Registered Engineer in training, preferred--
- OSHA/IOSH/NeBOSH Certification or equivalent, preferred--
- 5+ years Project Engineering relevant experience--
- 2+ years in a regulated industry (Life Sciences,
preferred)--
- Must be able to read and understand English-written job
instructions and safety requirements--Why you should join Catalent:
- Defined career path and annual performance review and feedback
process--
- Diverse, inclusive culture--
- 152 hours of PTO + 8 paid holidays
- Dynamic, fast-paced work environment
- 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 quarterly 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--
- Wellness programsCatalent 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, Bloomington , Senior Engineer - Process Engineering, Engineering , Bloomington, Indiana
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