Senior Equipment Process Engineer
Company: Disability Solutions
Location: Severn
Posted on: October 16, 2024
Job Description:
Senior Equipment Process EngineerPosition 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 a
Senior Engineer, Equipment who 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 a 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
onsite.-- The core hours are 8:00AM - 5:00PM 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
- Analyze and develop engineering solutions to maintenance,
continuous improvement, quality and safety initiatives, and failure
investigations for manufacturing equipment/systems,
instrumentation, and filling equipment;
- 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, fillers, isolators and laboratory equipment;
- Hands-on work with Fill/finish process scale-up and technology
transfer including the use of gap analysis, root cause analysis,
and risk assessment tools (e.g. Fish bone diagrams, FMEA,
etc.);
- Work within Computerized Maintenance Management Systems (CMMS)
to complete This position requires a professional who will be
expected to perform tasks autonomously at times; minimum
supervision required on day-to-day activities and accomplished
tasks;
- Will be required at times to lead engineering projects from
start to finish including documentation, scheduling, overseeing
maintenance mechanics and/or contractors;
- Supervisory input focused on status and future of project or
technical area and long-term development path;
- 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;
- All other duties as assigned;The Candidate
- Bachelor of Science in Engineering, chemical or mechanical
engineering required with 4+ years related work experience (GMP /
Bio-Pharma maintenance/ engineering).
- Demonstrated abilities in mechanical/electrical design, repairs
and maintenance;
- Understand and apply engineering principles to troubleshooting
and repairing bioprocess equipment and instrumentation;
- Experience with filling of drug product and familiarity with
aseptic filling equipment including isolator technology;
- Familiarity with cGMPs, regulatory filings, and compliance
issues for sterile injectable products manufactured by aseptic
processing;
- Application of current Good Manufacturing Practices (cGMPs) to
Phase I/II bulk and finished biologics;
- 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;
- Individual may be required to sit, stand, walk regularly and
occasionally lift 0-15 pounds;The Pay
- The anticipated salary range for this position in Maryland is
$93,280-128,260 plus shift differential and annual bonus, when
eligible.-- The final salary offered to a successful candidate may
vary, and will be dependent on several factors that may include but
are not limited to: the type and length of experience within the
job, type and length of experience within the industry, skillset,
education, business needs, etc. Catalent is a multi-state employer,
and this salary range may not reflect positions that work in other
states."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, Annandale , Senior Equipment Process Engineer, Engineering , Severn, Virginia
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