CSV Engineer

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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

CSV Engineer, Cork - Ireland

Gilead Sciences, Inc. is a research-based biopharmaceutical company that discovers, develops and commercializes 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.

The Position

Computer Systems Validation (CSV) role within the Validation Department, with a targeted focus on supporting CSV & Automation projects including EBR, MES, PIMS and PLC/SCADA upgrades. Flexibility & agility to support other validation workstreams (Process & Cleaning, Packaging, Facilities, Utilities & Equipment) as required to meet the business needs. Ability to integrate risk based validation strategies to site mandated projects. Create and sustain a positive and energised team dynamic and environment.

Job duties include:

Responsible for performing the CSV elements of equipment, utility systems, facilities, processes and/or automation systems for projects. This includes developing validation master plans with minimum supervision, preparing protocols independently, analyzing test results, and preparing technical reports.

Contributes directly to the completion of validation projects through the development of validation schedules, master plans, validation protocols and reports for systems that may be complex in nature, to support clinical and commercial manufacturing.

Embed data integrity principles into day to day operations and validation programs of activity.

Coordinates validation activities with, and seeks team supports from, Validation, Development, Manufacturing, Engineering, Quality, third Parties, and other groups on validation projects to ensure validation projects are carried out on time and on budget.

Foster validation team and transversal working relationships to deliver site mandated programs of activities on schedule and to high performance standards.

Identify and drive functional continuous improvement initiatives to achieve compliant and lean sustainable solutions.

Reviews protocols, reports and data tables generated by peers and contract personnel.

Represents the department on cross-functional project teams & site MDI boards.

Lead and deliver cross functional governances with key stakeholders.

As required, assists in preparation of regulatory submissions and presents validations in respective SME areas to regulatory authorities during routine internal and pre-approval inspections.

Knowledge, Experience and Skills:

• In-depth understanding and application of validation principles, concepts, practices, and standards incl GAMP, PART 11, Data Integrity, Annex 11
• Proficient in current Good Manufacturing Practices (GMPs).
• Extensive working knowledge of equipment and systems- specifically packaging & serialization operations.
• Extensive knowledge of industry practices.
• Working knowledge of E-Validation systems (preferably Kneat).
• Excellent verbal, technical writing, and interpersonal communication skills are required.
• Demonstrated investigation and report writing skills.
• Root Cause Analysis tools and operational excellence mindset.
• Proficient in Microsoft Office applications.
• Leadership experience – a distinct advantage
• Relevant experience and bachelor's degree in science or related field.
  

Behaviours

Resilient 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).

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 apply via the Internal Career Opportunities portal in Workday.