Jobs via Dice · 20 hours ago
Computer Validation systems Specialist
Grafton, WI
Full-time
Onsite
Mid, Senior Level
$80K/yr - $115K/yr
6+ years expApex Systems is a world-class IT services company that serves thousands of clients across the globe. The Computerized Systems Validation Specialist will lead and provide overall CSV activities of the GMP Computerized Systems used on the Grafton Site, supporting the creation and maintenance of necessary procedures and assisting in the configuration/customization of the Laboratory System.
Computer Software
Responsibilities
The scope of responsibilities for the validation activities lies on all local computerized systems from the Grafton site, including Chromeleon/Labware/Laboratory Standalone Systems, Site Manufacturing Computer System Validation (e.g., Delta V)
Support for change management and CSV activities on the rollout of global corporate quality systems on the site of Grafton
Lead validation activities throughout CSV lifecycle (implementation, production use, changes, retirement, Periodic Reviews)
Responsible to write, review, approve, and execute validation protocols and test scripts. Write final validation reports
Administration of laboratory information systems, CDS and standalone analytical equipment to address various system issues
Evaluates product enhancements and capabilities related to Data Integrity and compliance, in addition to implementing upgrades as required and defining the validation strategy and activities relating to these systems
Ensure the application of the corporate QCSV policies on the site of Grafton and participate to the network of CSV SMEs of Siegfried
Act as Subject Matter Expert during customer and regulatory audits
Support implementation and maintenance activities
Configures and customizes systems
Support the activities related to the integration of new instruments
Conducts user-training sessions for users
Adheres to personal moral, ethical, legal, and behavioral conduct that follows the Siegfried Code of Conduct
Adheres to all applicable SHE and cGMP regulations
Qualification
Required
A BS in chemistry from an accredited institution plus eight (8) years of work experience, or B.S. from an accredited institution plus six (6) years of work experience in Chemistry, Computer Science, or related field
Knowledge of cGMP is required as applied to computerized systems, electronic records/signatures, etc
Computer systems and validation experience
Achievement focused on appropriate alignment for regulatory and quality requirements
ISPE GAMP, ideally good practice guide Laboratory / manufacturing systems
Two years+ experience supporting laboratory systems in a R&D or QC laboratory in a cGMP regulated industry
Excellent verbal and written communication skills
Demonstrated working understanding of laboratory operations and practice strong organizational and/or project management skills
Strong analytical and problem-solving skills
Preferred
Advanced degree a plus
Benefits
Medical
Dental
Vision
Life
Disability
Other insurance plans
ESPP (employee stock purchase program)
401K program
HSA (Health Savings Account on the HDHP plan)
SupportLinc Employee Assistance Program (EAP) with up to 8 free counseling sessions
Corporate discount savings program
Other discounts
On-demand training program
Access to certification prep
Library of technical and leadership courses/books/seminars
Certification discounts
Perks to associations that include CompTIA and IIBA
Dedicated customer service team
Certified Career Coach
Company
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