Process Automation Engineer- Deviation Task Force
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 Automation Engineer role supports ongoing operations at the Portsmouth, NH site through technical assistance as it relates to manufacturing and process systems. The focus of the role is on ensuring manufacturing equipment and facilities are operating as intended to meet the requirements for biopharmaceutical manufacturing. Responsibilities of the Controls Engineering function include both tactical support of ongoing plant operations and strategic implementation of automation projects to meet the changing needs of the business. The role reports into the Cell Therapy Engineering department at the site.
- Support Deviation Task Force - Lead in Deviation investigations, impact assessments, analysis, and Corrective and Preventive Actions (CAPA).
- Develop technical knowledge on manufacturing equipment and processes.
- Participate in root cause analysis investigations and manage resolution of major equipment breakdowns and quality issues in the suites.
- Provide SME (subject matter expert) support to Manufacturing and other departments for the design and operation of process automation systems.
- Conduct troubleshooting and technical analyses on manufacturing equipment and process control systems including PI data analyses, CIP/SIP (clean-in-place/sterilization-in-place) circuit review, flow path analyses, code review/troubleshooting, etc.
- Assist with tech transfer of new processes into the facility.
- Acts as SME for Automation on behalf of department in audits and in IPT/JPT meetings with customer.
- Modify/develop preventative maintenance plans and create spare parts.
- Planning and execution of plant projects involving process automation system changes and process improvements.
- Execute commissioning protocols (installation, operation, CIP/SIP, wet testing).
- Own change requests and complete change request tasks to support project completion.
- Assist with deviation investigations, completion of CAPA actions and participate in quality risk assessments.
- Review/revise Engineering and Manufacturing related SOP’s, work instructions, and maintenance assessments/procedures as a result of CAPA, equipment/process changes, and error prevention activities.
- Complete process automation review/approval of batch records.
- Initiate updates to process automation documents including engineering and electrical drawings.
- Complete Controls review/approval of batch records, deviations, commissioning protocols, and validation protocols.
- Participate in 24/7 rotating on-call schedule.
- High School Diploma or Equivalent; BS in Engineering Discipline, Preferred area of study: Chemical, Electrical or Mechanical Engineering
- Substantial pharma/biotech industry experience (or equivalent)
- Practical experience in the application of engineering principles to plant systems; Biopharmaceutical/process experience preferred, but not required.
- Experience in the technical analysis of operational and design issues within an industrial environment
- Experience in coordination and managing of outside resources (vendors, consultants) to accomplish engineering objectives.
- Proficient with Microsoft Office Suite with focus on Outlook, Word, PowerPoint and Excel.
- Ability to effectively communicate via writing and oral communication both within the department and across departmental boundaries.
- Ability to work on several projects simultaneously ensuring compliance with quality and safety standards.
- Ability to secure relevant information and identify key issues and relationships from a base of information. Relate and compare data from different sources and identify cause and effect relationships.
- Ability to evaluate engineering problems and be able to devise cause and affect relationships and propose solutions.
- Demonstrating the proper level of detail for all aspects of the job.
- Ability to establish a project plan that outlines the course of action for self and/or others to accomplish a specific goal.
- Ability to keep customers/requesters and management apprised of status of work under your direction. Ability to maneuver around hurdles to accomplish goals/tasks
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.