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Catalent · 2 days ago

Senior Facilities Engineer

Harmans, MD

Full-time

Onsite

Mid, Senior Level

$93K/yr - $128K/yr

5+ years exp

Catalent, Inc. is a leading global contract development and manufacturing organization (CDMO) dedicated to delivering unparalleled service to pharma, biotech, and consumer health customers. The Sr. Facilities Engineer will provide engineering support for critical utilities in GMP manufacturing and work closely with various teams to design and enhance manufacturing capabilities.

BiotechnologyHealth CareManufacturingPharmaceutical

H1B Sponsor Likely

Responsibilities

Lead the design, implementation, and commissioning for new utility equipment and modifications to existing utility equipment and facilities within GMP Manufacturing

Author and review protocols, standard operating procedures, and provide technical assessment and approval for engineering and process changes

Work with industry /consultants to create design specifications, P&ID drawings, GA drawings, User Requirements, Functional Specifications and automation control strategies

Write and review technical documentation such as protocols and reports for FATs, SATs, and IQ/OQ/PQ testing

Provide technical solutions to facility and utility equipment problems

Perform investigations of manufacturing deviations and anomalies related to failure of facility systems

Perform utility monitoring, utility capability, statistical analysis and quality engineering activities

Qualification

Clean Utility SystemsGMP ManufacturingTechnical DocumentationChemical EngineeringBiochemical EngineeringMechanical EngineeringProblem SolvingTeam CollaborationCommunication Skills

Required

Bachelor's degree in Chemical, Biochemical or Mechanical Engineering, Biotechnology or equivalent and Five (5) years of related experience

Associate's degree in Chemical, Biochemical or Mechanical Engineering, Biotechnology or equivalent and Seven (7) years of related experience

In-depth understanding and knowledge of Clean Utility Systems including; WFI generation and distribution, purified water generation and distribution, clean steam generation and distribution, HVAC for clean rooms, and clean gas generation and distribution

Benefits

Competitive medical benefits and 401K

152 hours PTO + 8 Paid Holidays

Dynamic, fast-paced work environment

Opportunity to work on Continuous Improvement Processes

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)