Sr Process Engineer at Lonza Vacaville, CA

Sr Process Engineer job aville, CA. United States, Vacaville (California).

Provide engineering and technical expertise to support Capital Expense projects and operations at the Vacaville site. You will play a crucial role in supporting current and future production of biopharmaceutical processes and facilities, by assisting in new facility design and incorporation of new equipment and technology. Relying on your advanced experience in bioprocessing, guide and resolve complex process issues.

• Lead design teams, project teams, and contract engineering personnel.
• Lead engineering-related site or network initiatives.
• Mentor less experienced Engineering staff.

• Identify, analyze, and design improvements and capabilities for GMP facility, process, and equipment systems.
• Develop and maintain engineering documentation such as PFD’s, P&’s, design drawings and specifications, design review, and protocols (FAT, SAT, and IQ).
• Support development and review project documentation such as schedules, budget, URS, PEP, RFQs, Contractor Bid Packages, Statements of Work, and Credit Applications.
• Drive and manage planning and design phases including project initiation and conceptual/basic/detailed design depending on assignment.
• Drive and manage FAT, SAT, commissioning, and installation qualification.
• Support debug, operational and performance qualification, and handover to operations.
• Project Management (as applicable): (1) Develop and maintain project documentation noted above. (2) Manage construction phases including contractors, construction supervision, Lonza business processes, change orders, punch-list, turnover, and closure.
• Provide process/mechanical engineering expertise to support investigations, CAPA’s, audits, inspections, permits, and other technical requests.
• Support Global Engineering on major projects in a user team role.
• Collaborate with peers in continuous improvement of technical infrastructure including standards, practices, specifications, procedures, and business processes.

• Bachelor of science degree in engineering or related field.
• Minimum 10 years of relevant experience in a biotech, pharmaceutical, or related industry.
• Strong understanding and demonstrated ability with engineering principles and techniques.
• Knowledge of FDA and EMA cGMP’s, applicable building codes, and related regulations.
• Knowledge of project lifecycle including initiation, design, construction, and commissioning/validation.

Lonza is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a qualified individual with disability, protected veteran status, or any other characteristic protected by law.