Lead Engineer - Analytical Equipment Validation jobs in United States
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Lonza · 4 hours ago

Lead Engineer - Analytical Equipment Validation

positionPortsmouth, NH
timeFull-time
remoteOnsite
senioritySenior Level, Lead/Staff
date5+ years exp

Lonza is a global leader in life sciences manufacturing, and they are seeking a Lead Engineer for Analytical Equipment Validation. This role focuses on implementing industry best practices within the framework of GAMP regulations while providing guidance to junior team members.

BiotechnologyLife SciencePharmaceutical
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H1B Sponsor Likelynote

Responsibilities

Lead collaboration between internal teams and CSV to prioritize and complete activities on time
Maintain knowledge of Lonza policies, 21 CFR Part 11, Data Integrity, ICH Q7A, and GAMP principles
Perform QMS processes (Change Control, Deviation, CAPA) and validation maintenance of computerized systems
Participate in audits and inspections as a Subject Matter Expert
Own, revise and maintain CSV SOPs
Support qualification activities and documentation for CSV validation in line with regulatory guidelines
Mentor and train junior team members

Qualification

Computer Systems Validation21 CFR Part 11ISPE GAMP guidelinesGMP documentationCommunication skillsOrganizational skillsTime management skills

Required

Bachelor's Degree is required
5-10 years' of Computer Systems Validation experience
Experience with 21 CFR Part 11 and ISPE GAMP guidelines as they relate to Computer Systems Validation
Strong written and oral communication skills
Strong organizational and time management skills

Preferred

preferably in Computer Science/Software Engineering

Benefits

Medical, dental and vision insurance.

Company

Lonza

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Lonza Group supplies products and services to pharmaceutical and agrochemical industries.
dateFounded in 1897
location
Basel, Basel-Stadt, CHE
people-size10001+ employees
web-link
http://www.lonza.com

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 Company
Total Funding
$444.8M
2023-11-06Post Ipo Debt· $444.8M
2020-12-07IPO

Leadership Team

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Wolfgang Wienand
Chief Executive Officer
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Alfons Ehinger
Founder

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Company data provided by crunchbase