Lonza · 4 months ago
CQV Engineer IV, Quality Control - Allogenic
US - Portsmouth, NH
Full-time
Onsite
Senior Level
5+ years expLonza is a global leader in life sciences, and they are seeking a CQV Engineer IV to support the commissioning and qualification of equipment and systems. This role involves performing validation activities, ensuring compliance with regulatory requirements, and collaborating with cross-functional teams.
BiotechnologyLife SciencePharmaceutical
Responsibilities
Configures, tests, and validates electronic systems to ensure the systems are properly commissioned/qualified and validated per standards and regulatory requirements (e.g., FDA, EU)
Reads piping & instrumentation diagrams (P&IDs) to walkthrough systems in the field
Develops, Executes and manages equipment and system qualifications, validation protocols for manufacturing equipment, process support equipment (Bioreactors, clean steam generators, AHU) etc
Perform Periodic Review and Validation Maintenance (PRVM) for manufacturing equipment, process support equipment, etc
Identifies and assesses risks and escalates to management to develop and implement mitigation strategies
Develop and revise validation related standard operating procedures (SOPs) for manufacturing equipment, process support equipment, etc
Support work orders, maintenance plans, and other items in the computerized maintenance management system (CMMS)
Work closely with cross-functional teams including engineering, quality assurance, manufacturing, and other stakeholders
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
Remain up to date on all assigned training activities
Perform other duties as assigned
Qualification
Required
Associate's Degree in Chemistry, Computer Systems or related fields is required
5-10 years of experience within a regulated environment
Experience in Commissioning, Qualification and Validation
Broad knowledge of engineering disciplines, commissioning, compliance, qualification and quality aspects of biopharma or pharmaceutical manufacturing
Experience with Data Integrity and 21 CFR Part 11
Ability to work and communicate in a team environment
Ability to think critically and logically
Preferred
Bachelor's or Master's Degree
Company
Lonza
Lonza Group supplies products and services to pharmaceutical and agrochemical industries.
10001+ employees
H1B Sponsorship
Lonza has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2024 (3)
2022 (1)
2021 (3)
2020 (2)
Funding
Current Stage
Public CompanyTotal Funding
$444.8M2023-11-06Post Ipo Debt· $444.8M
2020-12-07IPO
Leadership Team
Wolfgang Wienand
Chief Executive Officer
Alfons Ehinger
Founder
Recent News
2026-01-07
2026-01-05
Company data provided by crunchbase