SENIOR ENGINEER, CELL AND GENE THERAPY
Company: Lonza
Location: Bacliff
Posted on: October 16, 2024
Job Description:
United States, Houston (Texas) 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 plannin g, e xecut ion 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
task s, a ctivit ies and documents. The individual in this role
will al so r epres ent 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 of 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 , D ata 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. Requ irements:
- 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. Reference: R60085
Keywords: Lonza, College Station , SENIOR ENGINEER, CELL AND GENE THERAPY, Healthcare , Bacliff, Texas
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