Senior Validation Specialist

Hiring By - Biostaffic

 BioPharma

Job Highlights

Not Disclosed

Remote Job

Mid-Senior level

Posted 4 months ago
Job details
POSITION SUMMARY:
The Senior Validation Specialist will liaise with IT Management and Quality Assurance to execute the Company's overall computer system validation strategy and is responsible for the development, execution and coordination of all computer systems and equipment validation, testing and documentation activities.
They will provide the appropriate strategy as well as direction and is hands on responsible for validation, testing and documentation activities, to ensure that all regulated IT applications and infrastructure components possess the necessary level of testing and required documentation to comply with applicable GCP/GxP regulations and customer requirements and expectations. This position manages validation activities across business units within a highly regulated environment.
DUTIES AND RESPONSIBILITIES:
  • Lead all validation activities, such as developing, managing, and maintaining full SDLC validation deliverables for the company's regulated computer systems, including Validation & Test Plans, User Requirement & Functional Specifications, Traceability Matrix, User Acceptance testing (UAT), and Validation Summary Reports and Certificates.
  • Liaise with Quality Assurance (QA) for final review and close out of GxP related platform validation and/or UAT validation event documentation.
  • Lead the Validation team to implement and maintain a risk-based validation model and identify tools and procedures to facilitate and improve test and document change management controls.
  • Ensure compliance of the company’s computer systems and medical equipment with regulatory requirements.
  • Ensure compliance and consistency of system validation SOPs with regulatory requirements, best industry practices and new FDA rulings.
  • Ensure complete and accurate documentation of company computer systems (validated and non-validated).
  • Participate in Sponsor audits and regulatory inspections as applicable.
JOB REQUIREMENTS / QUALIFICATIONS/EDUCATION:
  • Bachelor's Degree in a scientific, technology or life sciences discipline.
  • 4+ years for the non-senior role and 8+ years for senior role of experience in SDLC, testing, and validation, preferably in a GCP/GxP regulated environment within the Biotech/Pharmaceutical Industry. Experience in a Clinical Research Organization is desired.
  • Demonstrates expertise of Good Clinical Practice (GCP) and knowledge of applicable Codes of Federal Regulations as they apply to computerized systems.
  • Experienced with IT operating systems, database structure, system security and configuration for clinical research systems required. Knowledge of Veeva Vault, CRIO, IQVA e-TMF, Ensur QMS, Merative EDC strongly preferred.
  • In depth hands on experience in writing/developing all System and Validation documentation such as User Requirements Specifications, Functional Specifications, Validation Plans, Protocols, Scripts, Traceability Matrix, Validation Reports, Deviations, etc.
  • Experience supporting regulatory authority inspections
  • Industry related certifications preferred (e.g. PMP, CQE, etc.)
Knowledge, Skills, And Competencies Required
  • Experienced in IT System/Software Development Life Cycle (SDLC), change controls, system validation, testing and documentation needs and activities.
  • Excellent analytical, written, and oral communication skills.
  • Excellent interpersonal and organizational skills with strong attention to detail.
  • Proactive problem-solving skills.
  • Knowledge of the principles, methods, and procedures of clinical research.
CONDITIONS OF EMPLOYMENT
  • Verification of educational requirements, employment history, professional references, and certifications/training and U.S. work authorization.
WORKING CONDITIONS AND PHYSICAL EFFORT
  • Work is normally performed in a typical interior/office work environment, remotely or in a hybrid arrangement based on approval from the department manager/supervisor.
The above job description does not imply these outlined duties are the only duties performed by this employee. The incumbent is expected to perform other related duties necessary for the effective operation of the department and company.
ProSciento reserves the right to change or alter any of the above duties and responsibilities according to the operational needs of the department and company.
ProSciento is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.

Benefits Offered?

  • No

Bonus Offered?

  • No

Travel Required?

  • No

Experience:

  • Mid-Senior level

Remote Job:

  • Yes

Global Experience Needed?

  • No

Specialized Experience Needed?

  • No

Apply before:

  • Apr 14, 2024
Company Overview
ProSciento, Inc.
ProSciento, Inc.

Current Openings: 0

ProSciento is the leading clinical research organization focused on the continuum of metabolic diseases. Building on 20 years of experience and more than 375 metabolic clinical trials conducted, ProSciento provides customized clinical research services for multinational clinical trial programs designed to give our clients an advantage in today’s rapidly evolving landscape of metabolic drug and device development. For more information, please visit www.prosciento.com Email: bd@prosciento.com
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