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Catalent · 2 days ago

Engineer, Automation

Harmans, MD

Full-time

Onsite

Entry, Mid Level

$80K/yr - $110K/yr

1+ years exp

Catalent is a leading provider of GMP development and manufacturing services for advanced biopharmaceuticals. The Engineer, Automation will support various manufacturing systems, troubleshoot automation issues, and ensure compliance with GMPs while maintaining automation systems.

BiotechnologyHealth CareManufacturingPharmaceutical

H1B Sponsor Likely

Responsibilities

Establish the appropriate controls and administrate the automated and computerized systems

Support of a large-scale capital project to develop and implement automation systems in a new manufacturing area, then continued support of those systems as described throughout the description

Understand and support all GMPs, safety, and environmental regulations. Periodically reviews automation documents, preventive and corrective maintenance, and SOPs to ensure compliance with GMP and safety

On atypical automation situations, develops and supports corrective actions

Uses technical knowledge to assure the efficient operation of variety of automated processing and information technology systems. Supports installing and placing new equipment into operations

Ensures compliance to FDA regulations and follows GAMP in task execution, including change control and deviation investigations. Participates in audits and training programs for automated systems

On-floor support of manufacturing, process development and laboratory activities

Maintain technical documentation (manuals, drawings, software, etc.)

Provides client services support for business area applications

Offer technical support for plant downtime and automation-related issues during after-hours and weekends, as required, in accordance with the established coverage schedule

Other duties as assigned

Qualification

PLC programmingBioprocess equipmentOSI-PIIGNITIONEffective communication

Required

Associate's degree in engineering, Information Technology, Science, or related field required; Bachelor's preferred

Minimum 1 year of experience in an automation role supporting process, laboratory, or facility equipment; 2+ years preferred

Knowledge of bioprocess equipment (e.g., SU Bioreactors, Chromatography, Filtration) required

Effective interpersonal and communication skills (written and oral) are required

Position requires regular standing, walking, bending, and climbing; occasional lifting up to 30 lbs; manual dexterity to operate tools and equipment; clear visual inspection and documentation skills; and the ability to work in confined spaces or at a computer as needed, while adhering to all PPE and safety requirements

Preferred

Bachelor's degree in engineering, Information Technology, Science, or related field

2+ years of experience in an automation role supporting process, laboratory, or facility equipment

Experience with PLC programming and automation support in GMP environments preferred

Familiarity with OSI-PI and IGNITION systems preferred

Benefits

Medical, Dental, Vision, and 401K are all offered from day one of employment.

152 hours of PTO and 8 paid holidays.

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)