CSV Specialist

Siegfried•Grafton, WI

About The Position

Expect to grow", personally and professionally: At Siegfried, we offer exciting challenges and ample opportunities to showcase your talents. As a trusted and respected partner to the pharmaceutical industry, we uphold the highest standards in safety, quality and sustainability, while fostering a culture that empowers you to thrive. Join a rapidly expanding global company, where diverse perspectives and experiences come together in a collaborative environment. Here, you'll find a workplace that values both collective success and your individual contributions—offering long-term opportunities to grow and make an impact. Your Role: 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. Your Profile: 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 is in compliance with 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 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 a 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. Siegfried will explore and provide reasonable accommodations to assist any qualified individual with a disability in performing the essential functions of his/her job. Please speak with HR should you require an accommodation or have any questions.

Requirements

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 with 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 practices strong organizational and/or project management skills.
Strong analytical and problem-solving skills.

Nice To Haves

Advanced degree a plus

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 is in compliance with the Siegfried Code of Conduct
Adheres to all applicable SHE and cGMP regulations