Sr Project Engineer
Walkersville , MD 21793
Posted 2 months ago
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At Lonza, we invest in great people. We encourage our employees to challenge themselves and we offer an environment that fosters creativity and success.
Headquartered in Basel, Switzerland, we operate production, R&D, and business sites around the world, including Europe, North America, and Asia. Our vision: We strive to be the leading supplier using science and technology to improve the quality of life.
Our mission: We work with passion, using advanced technologies, to transform life science into new possibilities for our customers. Do you want to help us as we shape the future of this great organization?
Job Description Summary Sr. Project Engineer Walkersville, MD Overview/Role Purpose: Responsible for providing technical leadership and direct support in the execution and delivery of large Capital projects within Lonza, including adherence to schedule and budgets, engineering design of new facilities (Basis of Design, Conceptual, and Detailed Design), and leadership of cross functional teams consisting of Internal Lonza customers such as Manufacturing, MSAT, and Quality Assurance to properly identify design needs.
Key Accountabilities and Duties: Leadership of cross functional teams consisting of internal Lonza customers such as Manufacturing, MSAT and Quality Assurance to properly identify and define design requirements. Preparation of QA related documentation such as cGMP Process Change Controls.
Responsible to assure adherence to cGMP requirements throughout all phases of Capital Project execution Provide technical input in support of equipment procurement including bid package preparation, bid evaluation, vendor selection Construction, commissioning, startup activities, including supervision and management of external engineering contractors and equipment vendors. Responsible for delivering assuring Engineering Turnover Packages that are accurate, complete, and adhere to Quality Assurance requirements Project Close-out activities involving completion of technical close-out reports and summary of assets in accordance with Lonza financial recognition requirements Provide leadership and technical support during the construction and start-up phase (turnover documentation, IQ execution, system operation, troubleshooting and validation support). Provide routine project management updates in accordance with Lonza procedures. Perform other duties as assigned.
Minimum Required Qualifications/
High School Diploma or Equivalent; Bachelors Degree Required, Candidate should have BS ChemE, MechE or BioE Or equivalent experience. 10 years of experience in the design and operation of Biopharmaceutical facilities, both manufacturing and support systems (cGMP manufacturing, pilot plant & laboratories). 4 years of experience with control systems (PLC, DCS, Loop controllers) desirable. 6 years of experience in project management and coordination associated with the execution of capital projects in an industrial environment 6 years of practical experience in the management and coordination of engineering & construction management consultants, equipment vendors and contractors. 5 years Biotech experience in an engineering role. PM certification desired.
Capacity to deliver strong and effective project engineering skills on capital projects greater than $5 Million or on a case by case basis as agreed with various Lonza sites. Strong understanding of the fundamentals of large scale commercial chromatography and membrane separation processes and equipment including chromatography columns, column packing/unpacking, ultrafiltration/diafiltration, viral filtration, and sterile filtration. Strong understanding of the latest ASME Bioprocess Equipment standard including sanitary design of equipment/piping systems and design for Cleaning in place (CIP) and Sterilization in place (SIP) design and operation.
Experience with design and operation of large scale Distributed Control Systems (DCS), preferably the Emerson DeltaV platform. Building and Cleanroom design/construction knowledge. Candidate must have strong communication and project management skills to coordinate and manage the activities of internal Lonza staff, consultants, vendors and contractors to meet scope, schedule, budget, safety and quality requirements of assigned Capital projects.
Team player with exceptional customer service skills, integrity and ability to interact with all levels of personnel. Requires strong attention to detail and analytical skills as well as problem analysis and resolution. The employee is living the cultural beliefs with the flexibility to adapt to changing business priorities.
Is open to and actively seeks out feedback on their performance and translates that feedback into action. Ability to quickly adjust to a dynamic and fast paced environment This position does not require day to day supervision. Expected to work independently to achieve specified goals.
Understands business impact of decisions and applies risk assessment skills. 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. Lonza. The place to Go, Stay and Grow.