Equipment Process Engineer
Company: Disability Solutions
Location: Severn
Posted on: October 30, 2024
Job Description:
Equipment Process Engineer Position Summary: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 Cell & Gene Therapy is a growing Contract
Development and Manufacturing Organization (CDMO) with an
internationally recognized tradition of quality and service.
Catalent provides process development and GMP manufacturing
services for Phase I/II clinical trials to industry leaders as well
as innovative start-ups utilizing novel technologies to produce
state-of-the-art vaccines and therapies for people when they are
most in need. As a Catalent employee, you will actively contribute
to the delivery of our services and products to our customers and
their patients.Catalent Pharma Solutions in Harmans, MD is hiring
an Equipment Engineer is responsible for aspects of introducing a
new suite of biopharmaceutical products at our development and
manufacturing sites. The majority of process will be liquid
formulations manufactured under single-use production concept, in
cleanroom environment. This role is involved in onboarding new
process equipment, working closely on the ground with production
and development personnel, preparing and executing commissioning
and qualification protocols, organizing the production process
equipment layout, and coordinating with other departments to ensure
the validated status of process equipment. The project will require
a full-time engineer and is a tremendous opportunity for an
ambitious hands-on engineer to become a core team player in a team
working for an expanding CDMO. All work to be carried out in
compliance with cGMP and company standard operating procedures and
policies.This is a full-time, salaried role.-- This is on site. The
core hours are Monday - Friday 9:00AM - 5:00PMCatalent 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
- Analyze and develop engineering solutions to maintenance,
continuous improvement, quality and safety initiatives, and failure
investigations for manufacturing equipment/systems and
instrumentation;
- Work independently on assigned projects and collaboratively in
a multi-functional team environment supporting day-to-day
manufacturing schedules and operations;
- Hands-on work troubleshooting and repairing bioprocess
equipment. Equipment includes fermenters, bioreactors, centrifuges,
chromatography systems, incubators, BSCs, controlled temperature
units, and laboratory equipment;
- Work within Computerized Maintenance Management Systems (CMMS)
to complete preventive and responsive maintenance work orders;
- Work within manual and electronic Quality Systems to implement
equipment, facility, and automation change control, document
revisions, and conduct equipment/system/instrumentation failure
investigations;
- Work within manual and electronic Facilities Engineering
documentation systems to maintain engineering drawings and
equipment history files;
- Lead engineering projects from start to finish including
documentation, scheduling, overseeing maintenance mechanics and/or
contractors;
- Work in mechanical rooms on utility systems (high purity water,
boilers, chillers, HVAC, compressed air, specialty gases);
- Will be a company SME on bioprocess equipment across all
operating departments (process development, manufacturing,
testing/Quality Control);
- Work closely with facilities mechanics to minimize equipment
down times, expedite preventive maintenance (PM) schedules;
- All other duties as assigned;The Candidate
- Bachelor of Science in Engineering, Chemical or Mechanical
Engineering with 1+ years related work experience (GMP / Bio-Pharma
maintenance/ engineering) required;
- Demonstrated abilities in mechanical/electrical design, repairs
and maintenance;
- Understand and apply engineering principles to troubleshooting
and repairing bioprocess equipment and instrumentation;
- Demonstrate use of problem solving and continuous improvement
techniques;
- Knowledge of documentation practices associated cGMP operations
(SOPs, batch records, calibration and maintenance records,
equipment logbooks, change control, etc.;
- Knowledge of biopharmaceutical equipment design, construction,
operation, qualification, and maintenance;
- Knowledge of Metrology, instrumentation calibration practices,
equipment process controls, and building automation systems;
- Exhibit strong technical writing ability to clearly and
effectively communicate technical ideas and concepts;
- 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--
- 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--
- 152 Hours + 8 paid holidays
- Several Employee Resource Groups focusing on D&I
- Dynamic, fast-paced work environment
- Community engagement and green initiatives--
- Generous 401K match--
- Company match on donations to organizations
- Medical, dental and vision benefits effective day one of
employment--
- Tuition Reimbursement--- Let us help you finish your degree or
start a new degree!
- WellHub 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, Severn , Equipment Process Engineer, Engineering , Severn, Maryland
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