Senior Process Engineer jobs in United States
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Lonza · 2 days ago

Senior Process Engineer

Lonza is a global leader in life sciences manufacturing, and they are seeking a Senior Process Engineer. The role involves leading CAPEX projects, optimizing manufacturing processes, and ensuring compliance with industry standards.

BiotechnologyLife SciencePharmaceutical
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H1B Sponsor Likelynote

Responsibilities

Lead process-related CAPEX projects by developing scopes, URSs, budgets, schedules, and technical documentation in collaboration with internal stakeholders
Partner with internal customers, engineering design teams, and vendors to develop FRSs, FDSs, DDSs, and ensure process and equipment capabilities meet user and regulatory requirements
Serve as a process engineering SME by developing technical standards, providing expertise, and supporting manufacturing, utilities, and MSAT including technology transfer activities
Design, evaluate, and optimize manufacturing and utility processes for liquid and powder media, LAL operations, and associated equipment using lean and state-of-the-art technologies
Investigate, troubleshoot, and resolve complex process and equipment issues, including downtime events, manufacturing campaign support, and continuous improvement initiatives
Perform process capability studies, gap analyses, FMEA, modeling, and implement improvements to enhance reliability, efficiency, safety, sustainability, and cost effectiveness
Ensure compliance with industry and regulatory standards across process and equipment design, installation, operation, validation, audits, inspections, change management, and QA support
Oversee engineering documentation and project closeout deliverables, including SOPs, training records, AutoCAD/Revit models, P&IDs, specifications, manuals, and as-built records

Qualification

Control systems expertiseRegulatory compliance knowledgeProcess engineering experienceTroubleshooting skillsProject management skillsTechnical documentation skillsMicrosoft Office proficiencyAutoCAD proficiencyRevit proficiencyCommunication skillsOrganizational skillsInterpersonal skills

Required

Bachelor's degree in engineering or related field with 7+ years of experience in regulated manufacturing environments, supporting process, automation, or industrial systems
Strong expertise in control systems and automation platforms (e.g., DeltaV, Rockwell/Allen Bradley, Siemens, MODA-ES) and systems such as PLC, SCADA, DCS, MES/EBR, EMS, and BAS
Demonstrated experience managing automation, process, and equipment projects across design, procurement, construction, CQV, and operational phases
Solid understanding of regulatory and compliance standards including cGMP, 21 CFR Part 11, GAMP, Annex 11, IEC 62443, NIST, and cleanroom, aseptic, and sterile processing design
Ability to develop URSs, technical specifications, standards, drawings, SOPs, and documentation while supporting validation, audits, and continuous improvement efforts
Strong troubleshooting, analytical, and problem-solving skills with the ability to improve processes, equipment performance, and automation functionality
Excellent communication, organizational, and interpersonal skills; effective in matrixed, fast-paced environments and able to explain technical concepts to non-SMEs
Proficiency with Microsoft Office and engineering tools (AutoCAD, Revit, Autodesk Vault preferred) and a strong commitment to safety, teamwork, and professional accountability

Preferred

Proficiency with engineering tools (AutoCAD, Revit, Autodesk Vault preferred)

Benefits

Performance-related bonus.
Medical, dental and vision insurance.
401(k) matching plan.
Life insurance, as well as short-term and long-term disability insurance.
Employee assistance programs.
Paid time off (PTO).

Company

Lonza Group supplies products and services to pharmaceutical and agrochemical industries.

H1B Sponsorship

Lonza 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
Represents job field similar to this job
Trends of Total Sponsorships
2024 (3)
2022 (1)
2021 (3)
2020 (2)

Funding

Current Stage
Public Company
Total Funding
$444.8M
2023-11-06Post Ipo Debt· $444.8M
2020-12-07IPO

Leadership Team

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Wolfgang Wienand
Chief Executive Officer
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Alfons Ehinger
Founder
Company data provided by crunchbase