Job#: 3021010 Job Description: TITLE: Computerized Systems Validation SpecialistLOCATION: Onsite in Grafton WIPAY: $80,000 - $115,000 (based on experience)
HOURS: 8AM - 5PM Monday - FridayAPPLY HERE: Please email your resume to Skylar at
SUMMARY: The
Computerized Systems Validation Specialist will lead and provide overall CSV activities of the GMP Computerized Systems used on Grafton Site.
The position will support also in the creation/maintenance of necessary procedures and assist in the configuration/customization of the Laboratory System.
ESSENTIAL DUTIES, RESPONSIBILITIES AND ACCOUNTABILITIES:
- 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
EDUCATION AND EXPERIENCE:- 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.
- Advanced degree a plus
- 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.
OTHER 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.
Apex Systems is a world-class IT services company that serves thousands of clients across the globe. When you join Apex, you become part of a team that values innovation, collaboration, and continuous learning. We offer quality career resources, training, certifications, development opportunities, and a comprehensive benefits package. Our commitment to excellence is reflected in many awards, including ClearlyRated's Best of Staffing in Talent Satisfaction in the United States and Great Place to Work in the United Kingdom and Mexico. Apex uses a virtual recruiter as part of the application process. Click for more details.
Apex Benefits Overview: Apex offers a range of supplemental benefits, including medical, dental, vision, life, disability, and other insurance plans that offer an optional layer of financial protection. We offer an ESPP (employee stock purchase program) and a 401K program which allows you to contribute typically within 30 days of starting, with a company match after 12 months of tenure. Apex also offers a HSA (Health Savings Account on the HDHP plan), a SupportLinc Employee Assistance Program (EAP) with up to 8 free counseling sessions, a corporate discount savings program and other discounts. In terms of professional development, Apex hosts an on-demand training program, provides access to certification prep and a library of technical and leadership courses/books/seminars once you have 6+ months of tenure, and certification discounts and other perks to associations that include CompTIA and IIBA. Apex has a dedicated customer service team for our Consultants that can address questions around benefits and other resources, as well as a certified Career Coach. You can access a full list of our benefits, programs, support teams and resources within our 'Welcome Packet' as well, which an Apex team member can provide.
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