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Catalent · 5 days ago

Automation Engineer III

Chelsea, MA

Full-time

Onsite

Mid Level

$100K/yr - $130K/yr

3+ years exp

Catalent, Inc. is a leading global Contract Development and Manufacturing Organization (CDMO), and they are seeking an Automation Engineer III to lead the design and implementation of automation systems for clinical and commercial manufacturing. The role involves providing engineering expertise for the design, specification, and installation of automation systems, ensuring compliance with Good Manufacturing Practices (GMP) standards.

BiotechnologyHealth CareManufacturingPharmaceutical

H1B Sponsor Likely

Responsibilities

Provides engineering expertise for the design, specification, and installation of pharmaceutical manufacturing automation systems. Leads automation portion of expansion and upgrade projects

Performs and documents hardware/software modifications to existing systems. Ensures that all automation designs and technical documentation adhere to Good Manufacturing Practices (GMP) standards

Performs 21CFR Part11 assessments and GMP evaluations of control systems to ensure they meet FDA requirements. Prepares standard operating procedures for new and existing control equipment

Trains users on control system functionality (Programmable Logic Controller, Computer/Control Networks, Control Computers and Instrumentation)

Troubleshoots and diagnoses control system problems, working closely with maintenance, control technicians, and metrology

Supports software lifecycle, and electronic records/electronic signature compliance efforts

Supports change controls and technical aspects of control equipment investigations, as applicable

All other duties as assigned

Qualification

Automation systems designRockwell/Allen-Bradley systemsGMP compliancePharmaceutical process equipmentCIP systems knowledgeANSI/ISA-88 StandardSoft skills

Required

Bachelor's Degree in Chemical, Electrical or Mechanical Engineering required

Must have at least three (3) years of relevant experience

Experience with Rockwell/Allen-Bradley batch control systems or equivalent is required

Requires knowledge of: pharmaceutical process equipment and Clean In Place (CIP) systems, ANSI/ISA-88 Batch Control Standard, Allen Bradley/Rockwell FactoryTalk Process Control System, and relational databases and process automation protocols

Physical requirements: Individual may be required to sit, stand, walk regularly and occasionally lift 0-40 pounds

Preferred

Experience with other control systems (Siemens, Schneider, etc.) is preferred

Preferred experience working in FDA regulated operation in the pharmaceutical/biotech field

Benefits

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 categories

Company

Catalent

Catalent - Blow-Fill-Seal Sterile CDMO Business is focusing on complex clinical to commercial stage formulation and manufacturing. It is a sub-organization of Catalent Pharma Solutions.

Founded in 2007

Somerset, New Jersey, USA

10001+ employees

https://www.catalent.com

H1B Sponsorship

Catalent has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)

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2022 (1)