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.
Key responsibilities:
Leadership & People Management:
Lead design teams, project teams, and contract engineering personnel.
Lead engineering-related site or network initiatives.
Mentor less experienced Engineering staff.
Technical:
Identify, analyze, and design improvements and capabilities for GMP facility, process, and equipment systems.
Develop and maintain engineering documentation such as PFD’s, P&ID’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.
Key requirements:
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.
Every day, Lonza’s products and services have a positive impact on millions of people. For us, this is not only a great privilege, but also a great responsibility. How we achieve our business results is just as important as the achievements themselves. At Lonza, we respect and protect our people and our environment. Any success we achieve is no success at all if not achieved ethically.
People come to Lonza for the challenge and creativity of solving complex problems and developing new ideas in life sciences. In return, we offer the satisfaction that comes with improving lives all around the world. The satisfaction that comes with making a meaningful difference.
We recognize that attracting, developing, and retaining the best talent is key to our strategy and success as a company. As a result, we aim for flexibility in structuring competitive compensation offers to ensure that we are able to attract the best candidates. As required by law in this state, the quoted salary range for this position is $129,000 and $219,000. We use broad salary ranges that reflect the competitive market for similar jobs, provide sufficient opportunity for growth as you gain experience and expand responsibilities; while also allowing for differentiation on performance based on the breadth of our ranges, most new hires will start at the company between the lower and the middle part of the applicable range. We tailor our offers within the range based on job-related factors, including organizational needs, internal equity, market data, geographic area and the selected candidate’s experience, education, industry knowledge, location, technical and/or communication skills and other factors that may prove relevant during the selection process. This range is only inclusive of base salary, and base pay is just one component of Lonza’s total compensation package for employees. Full-time employees are eligible to receive a performance-related bonus, as well as a comprehensive benefits package including medical and dental coverage, 401k plan, life insurance, short-term and long-term disability insurance, an employee assistance program, paid time off (PTO), and more.
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.