Principal Engineer - Automation
Company: Disability Solutions
Location: Madison
Posted on: October 24, 2024
Job Description:
Principal Engineer - Automation 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
Automation Engineering Department is responsible for all computer
systems, network, and automation, of direct and indirect equipment
to the manufacturing process, laboratory, and facility systems.
Project management for information & operational technology (IOT)
initiatives. Engineers with the department are responsible for
working on a wide variety of systems and projects both within their
respective discipline and overlapping with other engineers giving
exposure to continued learning.----------------The Principal
Automation Engineer will support ongoing activities by assisting in
troubleshooting problems, identifying improvements to minimize
interruptions (down time) and supporting new and ongoing projects.
This includes system administration, system design production
support, laboratory equipment, process improvement, GAMP/Part 11
compliance, preventative maintenance, project support and
operational network designThis position will assist in identifying,
tracking, forecasting, and implementing capital expenditure
projects by working with site leadership and departmental end users
to identify the automation road map for the site and establish new
Standard Operating Procedures (SOPs) and/or recommend changes to
current SOPs based on site needs.This is a full-time on-site
position, Monday - Friday 8am-5pm.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:
- Administer the sites process control systems, digital control
systems, and equipment-specific systems.
- Monitor, maintain, and repair existing production and
laboratory control and monitoring systems (programmable logic
controllers (PLC type systems), software, etc.).
- Server management, disaster recovery, system backups, data
management, and--secure analytical data results. SQL, Historian, or
similar database administration. Configuration, Design, Queries,
and logistical extraction for reporting. Set up designated users
who will manage and create a--reporting structure.
- Create computerized equipment configuration, set up, procedures
and training, equipment and control system troubleshooting and
repair. Respond and assist with troubleshooting equipment problems
or connections and user access administration for both appropriate
levels of security control and user.
- Work with process engineers or facility technicians to ensure
equipment is running in an automated fashion, making improvements
to automated unit operations to minimize user interaction and add
consistency to production/product safety.
- Act as primary Subject Matter Expert (SME) for CSV and
alignment with corporate IT policies and working with Validation,
assist in drafting, reviewing, executing, and approving protocols
and reports related to Automation/Computer System Validation (CSV).
This includes deviation reporting during execution.
- Author and/or participate in investigations related to
deviations and deviation management caused by automated system
failures.
- Assist in responding to customer/regulatory audit observations
and corrective actions as it pertains to automation system
validation.
- Author system administrative procedures to ensure all aspects
of system management contains defined management steps and
sufficient detail to ensure consistent implementation. System Back
up, Access Reviews, Audit Trail Reviews, HMI/PLC Health, Server, or
computer updates
- Create and support site Automation Vision / Roadmap to keep
Catalent competitive with peers to be Partner of Choice for
external customer business and Continue Automation / Digitization
Roadmap for site Vision and Strategy of Automation Projects and
Improvements.
- Other during as assigned.The Candidate:
- Minimum Bachelor's degree in Engineering or related scientific
field with a minimum 8+ years' experience with facility network,
architecture, and integration in a cGMP environment (preferably
biopharmaceutical) implementing GAMP/Part 11 compliant
systems.
- Project management experience, preferred.
- Proficient in Excel, Word, and other office systems.
- Skilled in creating complex reports and delivering
presentations, with the ability to cross-train across various
groups.
- Capable of independently interpreting data, analyzing trends,
and completing investigation, deviation, and change control
forms.
- Experienced in operating and troubleshooting various
instrumentation and data systems (e.g., PCS, DeltaV, Allen/Bradley,
PLC).
- Ability to introduce new technologies, drive process
improvements, and collaborate with teams to develop and transfer
methods.
- Strong understanding and adherence to regulatory guidelines and
standards.
- Requires frequent sitting, standing, walking, reading, computer
use, and occasional physical activities such as lifting up to 50
pounds, with compliance to EHS responsibilities and ability to work
in HVAC-controlled and clean room environments.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.--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, Kenosha , Principal Engineer - Automation, Engineering , Madison, Wisconsin
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