Engineer - Facilities Engineering
Company: Disability Solutions
Location: Madison
Posted on: April 20, 2024
Job Description:
Engineer - Facilities EngineeringSummaryCatalent 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.The Engineering Department is responsible for
all facilities, automation, equipment and process operations of
direct and indirect equipment to the manufacturing process, and
project management for any CAPEX, Continuous Improvement and Ste
Strategy projects. This department manages facilities planning,
construction, and renovation, including primary contact and
management of architects, design engineers, contractors, and
subcontractors. The Engineering Department is also responsible for
managing the facility in a manner that assures uninterrupted cGMP
compliance in existing manufacturing areas, as well as the research
and process development areas.The Engineer will support ongoing
Facilities activities by assisting in troubleshooting mechanical
problems, identifying improvements in utilities to minimize
interruptions (down time) and reduce energy usage/cost, and
supporting new and ongoing projects. This position will further
assist in the management and planning of project budgets and
schedules and provide contractor oversight.This person will work on
complex facility-related problems requiring in-depth data analysis
to determine appropriate action. The Engineer is expected to have
extensive ongoing communication with employees and cross-functional
group managers/departments on facility-related issues.This is a
full-time on-site position, Monday - Friday 8am-4:30pm.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
- Support the multi-use facility, including HVAC systems, process
utilities, and bio-containment systems
- Assess the current and future state of site utility system
capacity and utilization and support selection and installation of
manufacturing equipment.
- Proactively and effectively partner with the facility
commissioning/validation team, including operational protocol
development, to implement compliance with FDA GMP
requirements.
- Draft SOPs for building operation, maintenance, and calibration
and identify improvements and efficiencies of facility preventative
maintenance.
- Provide engineering guidance and execution on facilities and
equipment projects
- Perform hands-on activities as needed to help troubleshoot
facility problems and support facility staff.
- Develop standard processes to evaluate future capital
projects.
- Create and maintain all aspects of equipment and facility
design files. Maintain facility compliance in accordance with the
site quality management system
- Author deviation investigation and change control process
- Other duties as assigned.The Candidate
- Minimum B.S. degree in Industrial, Electrical, Mechanical,
Chemical, or Civil Engineering
- Minimum 3 years' facilities operation/engineering experience in
a cGMP environment (preferably biopharmaceutical)
- Previous experience leading cross-department facility and/or
site improvement projects, a plus--
- Problem-solving (Lean Six Sigma) and change management
methodologies consistent with establishing a culture of continuous
improvement are preferred.
- Candidate needs to be highly motivated, have excellent written
and verbal communication skills, and critical thinking and
problem-solving skills. --
- Ability to use Excel, Word, and other office systems.
- Ability to cross-train on techniques across multiple groups and
is proficient in the operation and troubleshooting of a wide
variety of instrumentation and data systems.
- Understanding and adherence to applicable regulatory authority
and guidelinesPhysical 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 conditions will be Heating Ventilation and Air
Conditioned controlled.
- Ability to operate within a clean room environment as
needed.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, Madison , Engineer - Facilities Engineering, Engineering , Madison, Wisconsin
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