196 applicants
Novartis · 1 week ago
Senior Process Engineer, Multidiscipline
United States
Full-time
Remote
Senior Level
$124K/yr - $186K/yr
8+ years exp
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BiotechnologyHealth Care
Insider Connection @Novartis
Responsibilities
Maintain Master Instrument Inventory (MII) and Master Equipment Inventory (MEI). Set-up maintenance for new equipment (incl. spare part needs).
Assist with preparation of plans for maintenance / calibration / qualifications.
Provides hands-on support and guidance of installation, maintenance, troubleshooting, and repair of assets and systems which support the manufacturing facility.
Creates, reviews, and approves critical documentation such as operational procedures, maintenance plans, engineering drawings, and equipment specifications.
Manage technical / engineering changes: originate Change Request, approve Change Request, close Change Request.
Assist with preparation of estimates for bids and proposals.
Perform GMP risk assessments (incl. Sensors SRA).
Independently lead and/or provide SME-level support on all phases of projects, from identification to close out.
Ensure new equipment is appropriately designed/commissioned/qualified and existing processes run in a compliant manner throughout the equipment lifecycle.
Support internal and external audits.
Use automation (Scada / PLC's / Control Networks hardware) for data gathering and equipment optimization opportunities.
Assist in troubleshooting of process / plant equipment including isolator, filling line and utilities.
Interpret P&IDs, equipment/system layouts, wiring diagrams, and specifications and update as needed.
Supply information and technical data for securing spare parts.
Provide responsive customer support with emphasis on customer satisfaction.
Perform startup and commissioning & qualification activities as required.
Support and/or perform investigations / deviations from an engineering/maintenance perspective and help with data for timely closure of deviations and CAPAs.
Lead small teams to advance facility and equipment changes in line with 5- and 10-year strategic plans.
Complete and provide accurate documentation, as required in cGMP operations.
Actively monitor equipment performance in compliance with site reliability and maintenance strategies.
Collaborate with operations and manufacturing sciences to evaluate new product introductions and facility fit evaluations.
Other related duties as assigned.
Use CMMS system for documentation of relevant work.
Qualification
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Required
B.S. degree in Chemical, Electrical or Mechanical Engineering, or related technical field, with 8+ years’ experience providing maintenance, automation, engineering, or equivalent support within the pharmaceutical, biotechnology, or related industry
OR Associates Degree/Diploma/Certification in Engineering Technology or Related Skilled Technical Field, with 10+ years’ work experience providing maintenance, automation, engineering, or equivalent support within the pharmaceutical, biotechnology, or related industry
Having wide-ranging experience, uses professional concepts and company objectives to resolve complex issues in creative and effective ways
Excels in a team environment, with excellent communication and organizational skills. Promotes information sharing, facilitates groups to ensure open discussion
Exercises independent judgment in methods, techniques and evaluation criteria for obtaining results
Strong project management skill set with ability to manage projects from start-to-end
Applied knowledge of root cause analysis, equipment troubleshooting, automated building management systems, and industrial PLCs
Must be able to adhere to all applicable procedures, cGMPs, company policies and any other quality or regulatory requirements. (For example: OSHA, DEA, FDA, EMEA, ANVISA, HS&E, etc.)
Proficient computer skills. Experience using a Computerized Maintenance Management System (CMMS) like Blue Mountain Ram or SAP
Ability to climb ladders and lift up to 50 lbs.
Preferred
Aseptic Filling line, packaging operation experience is preferred
Training in radiochemistry or radio pharmacy is preferred
Benefits
401(k) eligibility
Various paid time off benefits, such as vacation, sick time, and parental leave
Company
Novartis
Novartis is a healthcare company that provides solutions to address the evolving needs of patients worldwide.
10,001+ employees
H1B Sponsorship
Novartis 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)
Distribution of Different Job Fields Receiving Sponsorship
Trends of Total Sponsorships
2023 (17)
2022 (18)
2021 (42)
2020 (26)
Funding
Current Stage
Public CompanyTotal Funding
$6.5MKey Investors
Bill & Melinda Gates Foundation
2018-02-14Grant· $6.5M
2000-05-19IPO· nyse:NVS
Leadership Team
Bharti Rai
VP Commercial Operations/Effectiveness, Insights and Analytics, US Pharma Executive Committee Member
Daniel Grant
Vice President & Global Program Head
Recent News
2024-06-06
2024-06-01
2024-06-01
Company data provided by crunchbase
