Senior Process Engineer

Senior Process Engineer

Location: This position is based in our Walkersville, MD office, the typical work schedule is Monday through Friday, 8:00 AM–5:00 PM EST.

What you will get:

The full-time base annual salary for this remote position is expected to range between $100,000 to $160,000. In addition, below you will find a comprehensive summary of the benefits package we offer:

• 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).

Compensation for this role will be determined by the candidate’s qualifications, skills, experience, and relevant knowledge.

What you will do:

• 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.

What we are looking for:

• 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.

About Lonza

At Lonza, our people are our greatest strength. With 30+ sites across five continents, our globally connected teams work together every day to manufacture the medicines of tomorrow. Our core values of Collaboration, Accountability, Excellence, Passion and Integrity reflect who we are and how we work together. Everyone’s ideas, big or small, have the potential to improve millions of lives, and that’s the kind of work we want you to be part of.

Innovation thrives when people from all backgrounds bring their unique perspectives to the table. At Lonza, we offer equal employment opportunities to all qualified applicants regardless of race, religion, color, national origin, sex, sexual orientation, gender identity, age, disability, veteran status, or any other characteristic protected by law. If you’re ready to help turn our customers’ breakthrough ideas into viable therapies, we look forward to welcoming you on board.

Ready to shape the future of life sciences? Apply now.