Validation Specialist Iv (W2 Only)

Job Title: Validation Specialist IV

Duties: The IT Validation Lead position is responsible for working closely with the South San Francisco Global Solutions Center's (GSC) internal business partners and key stakeholders across the PT business line. Above all, this role is tasked to lead validation efforts that support the application and implementation of technical, quality and scientific principles necessary to meet industry and customer requirements. The IT Validation Lead will primarily support the REMIS project, either through direct hands-on validation activities or by overseeing and managing contract Validation Specialists as required. This individual is expected to demonstrate leadership in a manner that is consistent with the Genentech core values, while working in a cross-functional team environment.

Leading and managing project validation efforts:

Provide risk assessment for new systems and changes to existing systems

Authoring both validation and test plans as well as reports

Plan and coordinate validation and testing activities such as SAT and UAT execution with key project team members

Review and approve key validation deliverables as well as overseeing testing and validation activities, assuring the quality of deliverables and documentation.

Execute and review of validation procedures and validation periodic review

Act as the resident Subject Matter Expert (SME) and provide expertise in the area of CSV including applicable regulations and corporate guidelines

Coach project members and key stakeholders in CSV and regulatory related requirements

Support and respond to internal and regulatory system audits

Quality System Records Ownership:

Create, own and manage life cycle of deviations, corrective actions and change controls for GMP systems

Working closely with Quality, Business Process Owner, IT Project managers and Technical Lead to investigate and resolve deviations including leading investigation teams in order to determine root cause, product impact, and appropriates corrective and preventive actions

Compliance:

Lead and conduct validation activities in compliance with applicable regulations and in accordance with corporate QMS

Acting as the single point of contact for all customer

Provide responses to audit observations and own audit related CAPA commitments

Improving the compliance infrastructure including creation of presentations and audit readiness material as required.

Skills:

Over 10+ years of relevant cGxP experience in Computer System Validation

At least 5 years of recent experience in validating manufacturing computer systems in a pharmaceutical or biotech enviornment

Demonstrated experience as a CSV and Validation Lead in a system life cycle context including the planning and supervising required validation activities and performing of system-related Risk Assessments of custom-built systems

Proficient knowledge and experience in two or more validation disciplines (Equipment or System Qualification, Utility, Laboratory, MES, Automation and or Computer Systems)

Knowledge of Computer System Validation Lifecycle Approach and review/approve lifecycle documentation (URS, FRS, FAT/SAT, Commissioning Protocols, etc.)

Author, review and/or approve validation deliverables as well as overseeing testing and validation activities and assuring the quality of deliverables and documentation

Experience in Validation using risk based approach

Experience in investigating deviations and determination of product impact potential, root cause, and corrective actions.

Experience with Change Management and change control process using HP Service Manager, Service Now is highly desirable.

Experience with electronic document management systems (Documentum, LiveLink, Share Point) and HP Application Lifecycle Management (HP ALM) is highly desirable

Ability to work as part of a high performing team and collaborate effectively with staff at all levels. Must have well-developed interpersonal skills with the ability to establish highly functional relationships with diverse personalities both

Demonstrated ability to manage multiple activities while maintaining a high level of organization

Demonstrates initiative, ability to undertake additional responsibilities and respond to situations with little or no supervision

Ability to make independent sound decisions and independently manage priorities in alignment with department and site drivers

Ability to read/interpret engineering drawings and design documents

Excellent technical writing and verbal communication skills

Skills and Experience:

Required Skills:

ACCEPTANCE TESTING

AUDITS

BUSINESS REQUIREMENTS

DOCUMENTATION

GMP

Additional Skills:

GXP

IT INFRASTRUCTURE

LEADS

LIFE CYCLE

LIFE SCIENCES

PRESENTATION SKILLS

PROCESS ANALYSIS

PROCESS FLOW

PRODUCT DEVELOPMENT

PROGRAM MANAGER

PROJECT LEADERSHIP

PROJECT MANAGEMENT

RISK ASSESSMENTS

SALESFORCE.COM

SOFTWARE DEVELOPMENT

SOLUTIONS

STRONG COMMUNICATION SKILLS

SYSTEM TESTING

SYSTEM VALIDATION

TECHNICAL SPECIFICATIONS

TEST PLANS

TESTING

USABILITY

USER ACCEPTANCE

USER ACCEPTANCE TESTING

VALIDATION/TESTING

BUSINESS SYSTEMS ANALYSIS

DEPLOYMENT