Plant/Process Engineer

The Plant/Process Engineer role supports ongoing operations at the Portsmouth, NH site. The site is conveniently located on the seacoast of New Hampshire just 60 miles north of Boston, MA. The site’s location makes it ideal for access to New Hampshire’s lakes and White Mountains while still being a short drive from Boston. Enjoy Portsmouth and the surrounding area’s quintessential New England charm without the congestion and traffic of a major urban center while working at a world class biopharmaceutical company.

The focus of the Plant/Process Engineer role is on ensuring manufacturing equipment and facilities are operating as intended to meet the requirements for biopharmaceutical manufacturing. Responsibilities of the Plant Engineering function include both tactical support of ongoing plant operations and strategic implementation of small engineering projects to meet the changing needs of the business.

Key responsibilities:

• Provide on the floor troubleshooting support for manufacturing operations especially with regard to equipment issues.
• Author GMP change requests for implementation of changes to equipment and facilities.
• Perform formal root cause analysis as part of deviation investigations.
• Act as subject matter expert (SME) for downstream equipment and unit operations
• Perform engineering review of batch records and standard operating procedures (SOPs)
• Own and implement projects to address Corrective Actions / Preventative Actions (CAPA) identified as part of deviation investigations, customer requests, or GMP audits.
• Assist with technical transfer of new customer processes into the facility by ensuring equipment designs meet customer requirements.
• Participate as engineering representative on cross functional support teams focusing on flawless execution of customer manufacturing campaigns.
• Assist with identification and creation of preventative maintenance plans for maintaining manufacturing equipment.
• Assist with identification and procurement of spare parts required for plant maintenance activities.
• Ensure materials of construction of manufacturing equipment are appropriate to meet process requirements.
• Perform detailed technical designs for new equipment or changes to existing equipment through an understanding of user requirements and completion of design reviews with project stakeholders.
• Support all phases of engineering project implementation to meet scope, schedule, budget, quality, and safety requirements.  This work includes preparation of scope of work documents, cost estimates, and project schedules. 
• Manage construction activities associated with implementation of engineering projects.
• Assist the Validation Department with execution of qualification protocols including IQ, OQ, and PQ
• Execution of commissioning and startup activities associated with equipment changes and new equipment installations including CIP/SIP commissioning.
• Review vendor turnover package documentation to ensure it meets all requirements.

Key requirements:

• A Bachelor of Science degree in Chemical Engineering, Mechanical Engineering, or related engineering field.
• 3+ years of experience in an engineering role supporting cGMP operations in a pharmaceutical/biopharmaceutical manufacturing plant.

• 2-5 Years of experience in the design and operation of biopharmaceutical manufacturing equipment and facilities.  
• 2-5 Years of experience in the design and operation of clean utility systems including purified water systems (e.g. WFI), clean steam, and clean gases.
• 2-5 Year of experience with control systems including PLC, DCS, and loop controllers.
• Experience in the management and coordination of engineering and construction management consultants, equipment vendors and contractors.
• Demonstrated mastery of technical drawings including PFDs, P&IDs, general arrangement drawings, and equipment design drawings is required.
• Detailed knowledge of ASME Bioprocessing Equipment (BPE) guidelines.
• Experience with pharmaceutical/biopharmaceutical manufacturing operations in a cGMP environment.
• Knowledge of downstream unit operations associated with biopharmaceutical manufacturing including: chromatography, tangential flow filtration, sterile filtration, viral filtration, and single use technologies.
• Strong knowledge of sanitary design aspects of biopharmaceutical manufacturing equipment including Clean in Place (CIP) and Steam in Place (SIP) concepts
• Proficiency with troubleshooting of complex equipment and performing formal root cause analysis investigations.
• Demonstrated ability to lead technical projects from concept through implementation.

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 it is 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.