QC Systems Validation Senior Lead at US02 Lonza Biologics Inc. in Portsmouth, New Hampshire

Job 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.

Lonza in Portsmouth, NH is searching for an experienced Quality Control Validation Sr Lead to join our phenomenal QC computer systems validation team.  As a QC Sr Lead, you will be responsible for day-to-day administration, validation and qualification of laboratory instrumentation and software the Portsmouth NH Site. Additionally, this position may assist other teams in the QC Laboratory Operations team such as Stability, Sample Management, Technology Transfer, and Data Integrity teams.

Key Responsibilities: 

• Completes QC analytical instrument and software validation deliverables, writes GMP procedures, validation documents and executes test scripts. Approves final project documents and writes final validation summary reports.


• Acts as leader for other team members.  Writes, reviews and approves QC analytical instrument and software validation project plans. 


• Independently drives projects to on-time completion.  Collaborates and prioritizes with other QC leaders to ensure agreed upon timelines are met.


• Software administration responsibilities include conversion of test methods, batch records and other written source documents into instrument computer system software.


• Performs user and application software administration on Enterprise systems. Completes system audit trail reviews, monitors back-ups and performs validation maintenance on systems.


• Recommends and implements analytical instrument and software engineering controls for QC Laboratories. Ensures data integrity and IT/OT security by configuring computer operating systems and application security policies, file/folder permissions, data back-up scheduler, instrument parameters and method templates. May be ACSV SME during regulatory and customer Inspections and Audits.


• Performs all aspects of QMS process’ – Change Control, Deviations, CAPAs, Tasks Writes, reviews, assesses, and/or approves change controls for analytical instruments and software used in QC laboratories and manufacturing.


• Maintain data integrity and ensure compliance with company SOPs and specifications, FDA, and cGMP regulations


• Identify compliance gaps and remediate these gaps as needed


• Other duties as assigned

Key Requirements: 

• Bachelor’s Degree required. Preferred area of study in Microbiology, Biochemistry, Chemistry, Engineering, Computer Science or Related Science Fields


• Minimum 5-7 years of experience in Analytical Laboratory Computer Systems and Instrument Validation


• Minimum 5 years of administration experience of local systems-  TOC, Softmax preferred


• Ability to solve problems and apply critical thinking 


• Strong understanding of regulatory requirements 


• Data integrity experience


• SDLC life cycle experience


• Experience working in Quality Control Laboratory or enterprise computer systems. and GMP Quality Systems such as TrackWise, LIMS, LES, Empower and MODA


• Previous project management experience

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.