- Work closely with Lonza operations teams in Safety, Quality, Manufacturing, R&D, Product Management and Purchasing to ensure a collaborative process development environment.
- Ensure technical expertise are assigned to design, develop and maintain the manufacturing production equipment and all product quality specifications.
- Manage department to respond to internal and external product improvement needs and validation activities.
- Follow established validation protocol to transition new products and processes to manufacturing.
- Oversight of validation process to include chemical and packaging raw materials and design of manufacturing equipment.
- Ensure all equipment is in compliance with safety regulations.
- Assist team in writing validations, review for completeness prior to signing, data collection and analysis to determine if parameters/performance were met.
- Ensure on-time delivery and review with project stakeholders before implementation.
- Ensure processes are capable of producing within end-product specifications.
- Facilitate/coordinate resources to provide technical and Engineering support to customers, manufacturing processes and the agarose manufacturing vendor.
- Provide oversight to the team to ensure managing and approving controlled documents, including customer specifications, protocols, product specifications, manufacturing procedures and standard operating instructions for equipment.
- Provide guidance for design of experiments, troubleshooting tools and root cause analysis. Ensure thorough investigations are completed and documented in the quality system to satisfy ISO and customer requirements.
- Support, develop, coach and mentor team to reach their full potential. Communicate company strategy and decisions to ensure clear objectives and understanding on how staff supports the overall Lonza business.
- Assign resources and set priorities to ensure timely delivery on projects. Review resource requirements, adjust staffing levels and develop personnel according to the needs of the business.
- Ensure quality/corporate/safety training is completed and documented to satisfy ISO requirements.
- Ensure effective preventive and predictive maintenance processes are in place to support maximum uptime and availability for both facilities and manufacturing equipment. Responsible for all facility maintenance contracts and oversight of contractor performance and safety.
- Ensure facility personnel are continuing to optimize service levels and minimize expenses and inventories.
- Maintain and execute equipment calibration system to ensure compliance.
- Develop and manage annual budgets in areas of responsibility. Seek to optimize spend by identifying opportunities for increased efficiencies and cost savings.
- Build vendor relationships and negotiate continuous improvements in the best interest of Lonza.
- Develop short- and long-term CAPEX expenditure needs for the Rockland site and provide oversight of project planning and execution.
Key Requirements:- Bachelor's level degree in Chemistry, Chemical Engineering, or Life Sciences
- 5+ years Engineering experience; biotech, pharma or related industry, discrete manufacturing and chemical process related preferred.
- 7 + years business experience and Management experience
- Working knowledge of either polysaccharides, molecular biology and/or chemical industry preferred
- Working knowledge of ISO 9001 standards or similar quality systems required.
- Develop and manage annual budgets in areas of responsibility, including developing short- and long-term CAPEX expenditure.
- Working knowledge of OSHA and NFPA requirements
- Ability to implement process improvements, Corrective Action/Preventive Actions (CAPA).
- Overall knowledge/understanding of manufacturing operations, process flows, supply chain, QA, QC, Safety
- Excellent communication, written and oral
- Self-motivated and responsible with strong work ethic
- Effective team leadership, development and positive contributor to team efforts
- Ability to provide hands on trouble shooting support
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.
- Bachelor's level degree in Chemistry, Chemical Engineering, or Life Sciences
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Process Engineering Manager - Rockland, United States - Lonza
Description
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.
Process Engineering Manager will manage the Technical Support and Engineering teams at our Lonza Rockland, ME who will provide technical expertise for all Rockland's processes and products. Manager will support organizational goals and improvement to operational effectiveness, efficiency and new product development. Manager will be Member of Rockland Leadership Team and will provide leadership and development to direct reports in support of improving skills and contributions to organizational goals. He/She will manage all aspects of the Technical teams, facility operating systems, and maintenance.
Key Responsibilities:
