CSV Specialist

SUMMARY:The Computerized Systems Validation Expert will lead and provide overall CSV activities of the GMP Computerized System used on Grafton Site. The position will also support 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). Write, review, approve, and execute validation protocols and test scripts. Write final validation reports.Support the administration of laboratory information systems, CDS, and standalone analytical equipment to address various system issues.Evaluate 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 in the network of CSV SMEs of Siegfried.Act as Subject Matter Expert during customer and regulatory audits.Support implementation and maintenance activities.Configure and customize systems.Support the activities related to the integration of new instruments.Conduct user-training sessions for users.Adhere to personal moral, ethical, legal, and behavioral conduct that is in compliance with the Siegfried Code of Conduct.Adhere 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 with 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 an R&D or QC laboratory in a cGMP regulated industry.Excellent verbal and written communication skills.Demonstrated working understanding of laboratory operations and practices; strong organizational and/or project management skills.Strong analytical and problem-solving skills.While performing the duties of this job, the employee is regularly required to stand; walk; or sit; use hands to finger, handle, or feel; and talk or hear. The employee frequently is required to reach with hands and arms. The employee is occasionally required to climb or balance; and stoop, kneel, crouch, or crawl. The employee must occasionally lift and/or move up to 50 pounds. Specific vision abilities required by this job include close vision and ability to adjust focus.

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