Job Description

Responsibilities:

Lead routine CSV lifecycle activities (system periodic validation lifecycle and audit trail / user access reviews), coordinating with system owners and Quality in accordance with company procedures and regulatory requirements.

Author, review and/or approve applicable CSV documentation.

Assist Business Owners and Technical Owners during test execution, document test failures and ensure testing aligns with internal procedures.

Assist Business Owners and Technical Owners to develop requirements and specifications for computerized systems used in GxP operations.

Support health authority inspections as a subject matter expert (SME) for routine CSV lifecycle activities (as required).

Other related duties as assigned.

Requirements:

Strong knowledge on MES systems (i.e. Emerson Syncade) and ERP systems (i.e. SAP or Oracle).

Familiar with development of CSV documentation (Validation Plans, Requirements, Specifications, Assessments, Test Scripts [IQ / OQ / PQ or equivalent], Summary Reports, Trace Matrices, SOPs, etc.)

Ability to effectively communicate with both technical and non-technical team members.

Strong interpersonal skills, especially regarding teamwork, client focus, verbal and written communication.

Knowledge of industry standard Quality and Compliance methodology to ensure our IT systems deliver the intended performance and ensure they meet regulatory requirements.

Knowledge of cGMP, GXP, GAMP, including 21CFR part 11, and good documentation practices.

Knowledge of IT service management platforms to support change IT operational events (i.e. ServiceNow).

Knowledge and exposure to Business Quality Management Systems (i.e. Veeva).

Strong technical and problem-solving skills and the ability to work independently.

Demonstrated success working in a high-performing, business results-driven environment.

Bachelor's degree in a life sciences, engineering, or technology discipline or a minimum of 5 years of equivalent biotechnology or pharmaceutical industry experience.

Must have experience with Computer system validation of MES.

Working knowledge of regulatory requirements and how they relate to existing and new business systems and practices, primarily GxP.

Job Tags

Permanent employment,

Similar Jobs