United States, Vacaville (California)
Today, Lonza is a global leader in life sciences operating across three continents. While we work in science, there’s no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, we let our people own their careers. Their ideas, big and small, genuinely improve the world. And that’s the kind of work we want to be part of.
The Senior Validation Engineer position is responsible for defining qualification / validation strategies and coordinating testing activities required to complete assigned projects in support of the operation of the Vacaville Commercial Manufacturing Facility. Performance of such validation activities include Equipment/Facility/Utility Qualification across the entire validation lifecycle from Plan to Retire.

KEY REQUIREMENTS:

• Bachelor’s degree in Engineering, Life Science, Biology, Biochemistry or relevant field.
• Proven senior-level experience in direct validation and/or GMP operations, with a history of increasing responsibility for validating a wide range of projects, including large-scale biochemical manufacturing equipment, facilities, utility, and automation systems.
• Proficient with validation principles, manufacturing processes, quality systems, engineering design fundamentals, regulatory agency expectations and industry trends.
• Strong technical writing, verbal communication, interpersonal and problem-solving skills.
• Ability to work independently, organize and manage individuals as well as lead larger scale projects.
  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 $93,000 and $149,000. 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.
  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.
  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.
  Reference: R70043

• Responsible for oversight and performance of Commissioning and Qualification of equipment, utility systems, automation systems, processes, and facilities.
• Prepares/Updates Validation Master Plans, Project Plans, and Protocols; Commissioning Plans, performs testing, collects samples, analyzes test results, and reviews summary reports generated by junior and contract personnel.
• Leads efforts by representing the department on project teams and coordinates activities of Engineering, MSAT, Manufacturing, Quality, and other Vacaville groups required to manage projects.
• Prepare specific validation summary sections of regulatory submissions and present validation packages to regulatory authorities and customers during audits and inspections.
• Leads/participates in resolutions to regulatory observations through the CAPA system.
• Provide technical assessment and validation review/approval for engineering, process, and standard operating procedure changes.
• Provide leadership to a group of Subject Matter Experts through the Quality Risk Management process and prepare Risk Management Reports documenting system risks, applicable remediation/risk reduction, and critical controls.
• Maintain training to ensure job responsibilities can be performed on a daily basis.