Tailored Management ยท 3 weeks ago
Validation Engineer II
Portsmouth, NH
Full-time
Hybrid
Mid Level
$34.58/hr - $57.64/hrLonza is a global leader in life sciences, and they are seeking a Validation Engineer II to support their Computer System Validation (CSV) team. This role involves ensuring compliance in a GMP environment while improving operational efficiency through validation practices and collaboration with team members.
ConsultingHuman ResourcesInformation Technology
Responsibilities
Act as CSV owner for significant site and process improvement projects, ensuring compliance with applicable regulatory requirements and industry standards
Perform risk assessments for computerized systems and manufacturing platforms
Review and approve change requests, test scripts, and validation documentation
Draft and execute validation protocols and support GMP documentation updates and revisions
Lead and support QMS processes, including Change Control, Deviations, and CAPAs
Support validation activities related to DCS (DeltaV) and MES (Syncade) systems
Identify potential roadblocks, recommend efficiencies, and support continuous improvement initiatives
Perform additional duties as assigned in support of validation and compliance activities
Qualification
Required
Significant hands-on experience with equipment and/or computer system validation in a regulated environment
Strong working knowledge of Controls Automation, Process Control Systems, Distributed Control Systems (DCS), and Manufacturing Execution Systems (MES); DeltaV experience preferred
Prior experience leading validation or improvement projects within the Biotech, Pharma, or Biologics industry
Demonstrated ability to work independently, manage multiple priorities, and meet project deadlines
High attention to detail with a strong understanding of GMP and regulatory compliance
Benefits
Weekly pay
Medical
Dental
Vision
Company
Tailored Management
Tailored Management is a staffing and recruiting company that offers information technology staffing and recruitment services.
Founded in 2009
501-1000 employees
H1B Sponsorship
Tailored Management 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 (1)
2020 (2)
Funding
Current Stage
Late StageLeadership Team
Jeff Anderson
Managing Partner & Client Relations Executive
Savannah Deskins
Manager, Administration & Office of the CEO
Company data provided by crunchbase