Process Engineer

Please note:
We are only considering W2 candidates at this time. Applications from third-party vendors or C2C arrangements will not be considered.

ADVENT Engineering is an engineering and consulting firm providing expertise to the pharmaceutical and biotechnology industries. Head-quartered near San Francisco, California, and with operations in the Eastern and Western US, Canada and Singapore, our company is involved in almost every facet of global pharmaceutical and biotechnology facility design and process engineering and quality system projects.

ADVENT's services include process engineering, automation engineering, project engineering, facility/system design, start up and commissioning, validation and compliance consulting for distinguished and successful biotechnology and pharmaceutical manufacturing companies.

The successful candidate will work with a group of engineers involved in the design, automation, commissioning and start-up of various processes, systems and facilities. A combination of strong technical aptitude, automation engineering skills and technical writing are the desired skill set.

This is an outstanding opportunity to join our growing team!

We are seeking experienced Process Engineers to support capital projects, facility start-up, equipment installations, commissioning activities, lifecycle documentation, and engineering deliverables within GMP-regulated pharmaceutical and biotechnology environments. This role will support design and start-up of cGMP large molecule manufacturing.

The ideal candidate will have strong experience in engineering support and process technology. Additional responsibilities include commissioning, qualification, validation, engineering documentation, and GMP facility support within regulated manufacturing environments.

• Create engineering design packages in compliance with operational, maintenance, and regulatory requirements.
• Develop, review, and update technical specifications for equipment and facility systems.
• Provide engineering oversight during design, fabrication, installation, startup, and commissioning activities.
• Coordinate activities with vendors, contractors, architects, engineers, and internal stakeholders.
• Provide technical leadership for schedule reviews, risk assessments, and mitigation planning activities.
• Author, execute, review, and manage change controls in accordance with GMP and quality requirements.
• Review and update engineering drawings, P&IDs, SOPs, technical documentation, and as-built drawings.
• Support commissioning and qualification activities including FAT, SAT, IQ, OQ, and related protocols.
• Partner with Validation and Quality teams to ensure systems meet compliance and operational readiness requirements.
• Support deviation investigations, CAPAs, inspection readiness activities, and continuous improvement initiatives.
• Troubleshoot manufacturing, utility, and facility systems to support ongoing operations.
• Support startup, shutdown, impairment, and transition activities during project execution.
• Participate in operational, project, and cross-functional coordination meetings.
• Provide timely project updates, documentation, and status reporting.

• 7+ Years of process engineering experience in cGMP Manufacturing environment
• Strong technical and project leadership experience
• Strong knowledge of GMP-regulated pharmaceutical or biotechnology manufacturing environments.
• Ability to read and interpret engineering drawings, P&IDs, specifications, equipment manuals, and vendor documentation.
• Knowledge of FDA and EU regulatory requirements including 21 CFR Part 11, Annex 1, GMP, GEP, ISO, GAMP, USP, ASME BPE, ISA, and ANSI standards.
• Experience creating and managing lifecycle documentation including:
• User Requirements Specifications (URS)
• Functional Specifications
• Experience managing change controls, deviations, and CAPAs within GMP environments.
• Familiarity with cleanroom classifications (ISO 5/7/8 and Grade A/B/C/D environments).
• Experience with CMMS, BMS, EMS, and SCADA systems preferred.
• Strong technical writing, communication, and cross-functional collaboration skills.
• Ability to gown and work…