Sr Validation Engineer
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POST DATE 9/15/2016
END DATE 11/18/2016
Gilead Sciences, Inc
JOB DESCRIPTIONSPECIFIC RESPONSIBILITIES
The Sr Validation Engineer, Biologics serves as subject matter expert for computer system validation. He/she will be responsible for validation deliverables for projects as well as participation as an interactive member on Project Teams as a representative of the QA validation department. Writes and executes commissioning, qualification and validation documents on equipment, instruments, facilities, utilities, processes and computer systems, utilizing the lifecycle approach, in accordance with the Site Validation Master Plan, project specific Validation Plans, and applicable SOP s. The position is also responsible for the analysis of data, completion of validation protocols, and protocol and validation plan summary reports. Participation on various project teams will be required.
Specifics may include, but are not limited to:
Development and approval of qualification lifecycle documentation as well as writing and revising SOPs as necessary.
Responsible for protocol execution requiring interface and coordination with Validation Contractor personnel, Manufacturing, QA, QC, and Engineering departments as part of a project team to assure expeditious and accurate completion per agreed upon project plan.
Summarize and evaluate protocol data involving resolution of discrepancies and exceptions as required for completion of validation summary reports.
Perform periodic reviews or re-qualifications to maintain validation status of equipment, facilities, utilities and computer systems as defined by approved validation SOPs.
Exercises judgment within well-defined practices and policies in selecting methods, techniques and evaluation criteria for obtaining results.
Works on problems ranging from moderately complex to complex in scope, where analysis of situations or data requires in-depth evaluation of various factors. Good judgment is required in resolving problems and making routine recommendations.
Leads and coordinates reviews and investigations of a larger magnitude.
May be responsible for managing the daily work flow of a project team
May interface with regulatory agencies as required.
May serve as a team representative on cross-functional projects to support more senior colleagues in the function; or
May serve as a project lead within the function.
Task management of employees/ contractors and some personnel management may be required.
The strong candidate:
Demonstrates ability to execute against the strategic and tactical objectives provided by senior leaders both within validation and outside of the function.
Demonstrates ability in integrating varied concepts and data to develop relevant solutions.
Demonstrates ability to create an energizing team environment.
Demonstrates ability to successfully interact with other functions on projects that involve negotiation and collaboration with cross-functional peers and more senior management levels.
Provides expertise and guidance in interpreting governmental regulations, agency guidelines, and internal policies to assure compliance.
Works on more complex problems, where analysis of situations or data requires in-depth evaluation of various factors. Strong judgment is required in resolving problems and making recommendations typically high impact issues that have implications across functions.
Exercises judgment within defined practices and policies in selecting methods, techniques and evaluation criteria for obtaining results.
May serve as a liaison between Gilead and the various governmental agencies/ regulators and external auditors.
Works under consultative direction toward pre-determined long-range goals and objectives.
Gilead Sciences, Inc. is a research-based biopharmaceutical company founded in 1987. Together we deliver life-saving therapies to patients in need. With the commitment and drive you bring to the workplace every day, you will be part of a team that is changing the world and helping millions of people live healthier, more fulfilling lives. Our worldwide staff is a close community where you can see the tangible results of your contributions, where every individual matters, and everyone has a chance to enhance their skills through ongoing development. Our scientific focus has resulted in marketed products that are benefiting hundreds of thousands of people, a pipeline of late-stage drug candidates, and unmatched patient access programs to ensure medications are available to those who could otherwise not afford them. By joining Gilead, you will further our mission to address unmet medical needs and improve life by advancing the care of patients with life-threatening diseases.
ESSENTIAL DUTIES AND JOB FUNCTIONS
Responsible for performing the validation 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.
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.
Coordinates the activities of assigned validation and contract personnel and ensures the quality of completed work.
Reviews protocols, reports and data tables generated by peers and contract personnel.
Represents the department on cross-functional project teams.
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
7+ years of relevant experience and bachelor s degree in science or related field.
5+ years of relevant experience and a MS or MBA.
3+ years of relevant experience and a PhD.
Proficient in all aspects of the computer systems validation including, but not limited to, standalone systems, open/closed systems, client/server based systems, PLC based systems, DeltaV, BMS, PI OSI soft, EMS, data historian, data backup/archiving strategies, disaster recovery, and configuration management.
Experience with validation and change management of large user base systems including MCS systems, Document Management Systems, and other Quality systems.
Proficient with computer applications (MS Office). Working knowledge of controlled documentation and data systems.
Strong interpersonal and communications skills; written and oral, and a demonstrated ability to make logical decisions based on guidance from management.
In-depth understanding and application of validation principles, concepts, practices, and standards.
Proficient in current Good Manufacturing Practices (GMPs) and Good Engineering Practices (GEPs).
Extensive working knowledge of equipment and systems.
As an equal opportunity employer, Gilead Sciences Inc. is committed to a diverse workforce. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact firstname.lastname@example.org for assistance.
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