Senior Validation Engineer

at  Gilead Sciences

For Current Gilead Employees and Contractors:
Please log onto your
Internal Career Site
to apply for this job.
At Gilead, we’re creating a healthier world for all people. For more than 35 years, we’ve tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer – working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the world’s biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference.
Every member of Gilead’s team plays a critical role in the discovery and development of life-changing scientific innovations. Our employees are our greatest asset as we work to achieve our bold ambitions, and we’re looking for the next wave of passionate and ambitious people ready to make a direct impact.
We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Gilead and help create possible, together.
Job Description
Senior Validation Engineer – Packaging Workstream, Cork
Gilead Sciences, Inc. is a research-based biopharmaceutical company that discovers, develops and commercialises innovative medicines in areas of unmet medical need. With each new discovery and investigational drug candidate, we seek to improve the care of patients living with life-threatening diseases around the world. Gilead’s therapeutic areas of focus include HIV/AIDS, liver diseases, cancer and inflammation, and serious respiratory and cardiovascular conditions.
Validation Department
The Validation department in GSIUC currently consists of 4 individual work streams as follows:
Facility, Utility & Equipment Qualification, Process & Cleaning Validation, Computer Systems Validation & Packaging Qualification
Each Validation Engineer is currently designated to an individual work stream with a view to being cross trained in the other areas for maximum business flexibility.
Validation Role:
Validation Engineer III – Process & Cleaning Workstream
Specific Job Responsibilities:

Process & Cleaning Workstream

• New Product Launches
• Process Validation
• Cleaning Validation
• Internal Technical Transfers
• Routine Monitoring
• Process Optimisations
• Technical Support

General Job Responsibilities:

• Generation, review and approval of all process and cleaning validation life-cycle documentation
• Deviation, change control assessment & technical support for routine manufacturing operations.
• Technical and Validation SME to support all regulatory/corporate inspections, internal audits and Regulatory Compliance Activities
• Participate in the governance of workstream projects, scheduling and delivery of activities in accordance with program timelines.
• Functional representative on cross-functional projects
• Supports and leads investigations of a larger magnitude.
• Executes test plans according to approved procedures, collects samples, tabulates test results, and organizes data packages.
• Generation of Product Annual Quality Reviews & System Periodic Reviews as required
• Compiles and analyzes validation data, prepares risk assessments, reports and makes recommendations for changes and/or improvements.
• Maintains master plans and SOPs pertaining to validation.

Knowledge, Experience and Skills:

• Extensive understanding and application of validation principles, concepts, practices, and standards.
• Knowledge of Process & Cleaning Validation- a distinct advantage.
• Proficient in current Good Manufacturing Practices (GMPs).
• Full knowledge of industry practices.
• Strong verbal, written, and interpersonal communication skills are required.
• Investigation and report writing skills.
• Proficient in Microsoft Office applications.
• Specific Education & Experience Requirements:
• Relevant experience and bachelor’s degree in science or related field.
• Relevant experience and a MS or MBA.
• Relevant experience and a PhD.

Behaviours

• Resilient & dynamic profile with the ability to deliver in an ambiguous environment
• Ability to engage and manage multiple stakeholders to achieve the objective
• Curious with learning agility
• Operationally excellent
• Organised with systematic approach to prioritisation
• Process orientated to achieve the business objective

Gilead Core Values

• Integrity (always doing the right thing),
• Teamwork (collaborating in good faith),
• Excellence (working at a high level of commitment and capability)
• Accountability (taking personal responsibility).
• Inclusion (encouraging diversity)

Equal Employment Opportunity (EEO)
It is the policy of Gilead Sciences, Inc. and its subsidiaries and affiliates (collectively “Gilead” or the “Company") to recruit select and employ the most qualified persons available for positions throughout the Company. Except if otherwise provided by applicable law, all employment actions relating to issues such as compensation, benefits, transfers, layoffs, returns from layoffs, company-sponsored training, education assistance, social and recreational programs are administered on a non-discriminatory basis (i.e. without regard to protected characteristics or prohibited grounds, which may include an individual’s gender, race, color, national origin, ancestry, religion, creed, physical or mental disability, marital status, sexual orientation, medical condition, veteran status, and age, unless such protection is prohibited by federal, state, municipal, provincial, local or other applicable laws). Gilead also prohibits discrimination based on any other characteristics protected by applicable laws.
For Current Gilead Employees and Contractors:
Please log onto your
Internal Career Site
to apply for this job

• Generation, review and approval of all process and cleaning validation life-cycle documentation
• Deviation, change control assessment & technical support for routine manufacturing operations.
• Technical and Validation SME to support all regulatory/corporate inspections, internal audits and Regulatory Compliance Activities
• Participate in the governance of workstream projects, scheduling and delivery of activities in accordance with program timelines.
• Functional representative on cross-functional projects
• Supports and leads investigations of a larger magnitude.
• Executes test plans according to approved procedures, collects samples, tabulates test results, and organizes data packages.
• Generation of Product Annual Quality Reviews & System Periodic Reviews as required
• Compiles and analyzes validation data, prepares risk assessments, reports and makes recommendations for changes and/or improvements.
• Maintains master plans and SOPs pertaining to validation