Process Validation Engineer
Company: Lonza
Location: Houston
Posted on: October 9, 2024
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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. Our Lonza site
in Houston is seeking a Senior Process Validation Engineer. The Sr
Process Validation Engineer is responsible for the planning,
execution and close-out of the PPQ/PV and/or CPV activities for
Viral Vector and/or Cell Therapy processes to ensure on-time and
in-full delivery of the associated tasks, activities and documents.
The individual in this role will also represent Lonza at client
facing meetings and may provide guidance and support to other
engineers on the team. Responsibilities: Knowledge of regulatory
requirements for biologics (experience in the CGT space is a plus),
New Product Introduction and Process Lifecycle requirements and
audit support skills. Manages, tracks and reports on
readiness/execution status for PPQ / CPV activities and
deliverables. Responsible for Global Data Mart data verification,
oversight, and generation of control charts and run charts for CPV
reports. Generates CPV reports at the required reporting
frequencies. Serves as the project lead for PPQ / CPV and point of
contact between Client, Quality Control, Quality Assurance, Supply
Chain, Manufacturing, Data Science, and/or the Commercial
Development Organization, as required. Works with other MSAT teams
on complex problems of diverse scope where analysis of situation or
data requires evaluation of process. Actively contributes to
continuous improvement activities for the applicable processes and
deliverables within the organization. Data Management, Generation
of Process Validation/CPV documents. Organizes, manages and
interprets data, performs detailed data analysis. Generates PPQ/PV
and/or CPV documents (plans, protocols, reports) according to
timelines and commitments/Quality Agreements. Perform other duties
as assigned and/or required based on business needs. Requirements:
Bachelor's degree in Chemical Engineering, Biochemical Engineering
or other Life Sciences Degree. 5+ years of experience/ SME level of
understanding with manufacturing/ aseptic processes, process
validation, Process Performance Qualification (PPQ) and Continued
Process Verification (CPV). Extensive experience within cGMP
regulated production environment. CGT (Cell and Gene Therapy)
experience preferred. Experience working with quality systems. The
ability to interface and communicate directly with clients will be
required. Strong technical writing skills. 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. Employment Type: Full Time Bonus/Commission: No
Keywords: Lonza, College Station , Process Validation Engineer, Engineering , Houston, Texas
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