Tech USA
Technical Recruiter at Tech USA | Philadelphia, PA
Job Title:
Lead Validation Specialist
Working Group:
Information Technology
Reports to:
Manager, Database Validation or above
Responsible for:
N/A (Functional Management Role)
Job Overview Scope of Responsibility / Level of Oversight, Authority & Independent Decision‑Making:
Provides project leadership for the validation team to ensure the quality of assignments and adherence to timelines
Exercises high level of independent decision‑making
Performs tasks and initiatives with minimal guidance
Key Responsibilities The primary responsibilities of this position include, but are not limited to, the following:
Develops validation testing strategies for on‑prem and cloud‑based regulated and non‑regulated computerized systems in accordance with industry standards and regulations.
Provides guidance on validation approaches, best practices and analysis.
Manages and packages all SDLC Deliverables in preparation for system audits.
Mentors and coaches validation team to foster best practices and ensure high‑quality work.
Oversees validation projects, including: task assignment, resourcing and timely delivery.
Validates and tests applications built on cloud data storage or relational databases (Oracle, MS SQL), with a focus on data flow integrity in compliance with ALCOA+.
Analyzes business requirements and technical requirements to develop testable conditions and scenarios.
Designs and executes test cases to ensure system compliance, data integrity, accuracy and traceability throughout the Systems Life Cycle.
Validates clinical systems in compliance with GxP, GAMP, 21 CFR Part 11, and applicable regulatory guidelines.
Reviews, analyzes and creates test data, comprehends data mapping and interprets results to support validation efforts.
Creates Validation Package deliverables including Validation Plan, Traceability Matrix, Test Plan, Acceptance Test Scripts (Functional, UAT, Performance, Integration, Data Quality and Regression), and Summary Reports
Participates in risk assessments and impact analysis related to system changes.
Rapidly identifies critical validation areas when project scope or requirements change.
Builds reusable and modular validation components to support system scalability and change control.
Provides feedback on User and Functional Requirements Specifications to ensure requirements are clearly defined and testable.
Represents department on cross‑functional teams, projects, and GXP‑related problem resolution.
Differentiates between true system issues and evolving user requirements or configuration change
Conducts defect analysis and delivers precise, actionable insight to development teams to facilitate efficient issue resolution.
When roadblocks, defects, or scheduling challenges are encountered in testing, finds solutions to enable successful and on‑time completion of validation projects
Identifies ways to streamline processes in validation, while not compromising adherence to SOPs and GCP regulations
Qualifications Level of Education
Bachelor’s Degree required
Prior Experience
8+ years prior experience inclusive of computer systems validation required
5+ years relevant experience in Leading a Validation Team
Strong experience working with relational databases (Oracle, MS SQL) to ensure data integrity in compliance with ALCOA+
Prior experience working in a Life Science regulated industry required
Skills and Competencies
Strong knowledge of computer systems validation (SDLC, Agile methodologies)
Knowledge and understanding of Regulatory Guidelines for the use of computer systems required
Ability to research and analyze system requirements, develop alternatives, and implement solutions
Knowledge of web technology and cloud‑based systems
Strong communication skills, both verbal and written
Proven analytical, problem solving and technical skills
Ability to absorb and retain information quickly
Advanced knowledge of Excel
Comfortable working in fast‑paced environments with evolving priorities
Self‑starter with the ability to work independently and in cross‑functional teams
Excellent interpersonal skills
Highly organized and result‑oriented
Keen attention to detail
Additional Requirements
Able to work effectively as an onsite or remote worker
Willing to travel to meetings as needed occasionally. Advance notice will be provided.
Must be highly fluent in English
Seniority Level Mid‑Senior level
Employment Type Full‑time
Job Function Information Technology and Project Management
Industries Pharmaceutical Manufacturing, Biotechnology Research, and Information Services
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Lead Validation Specialist
Working Group:
Information Technology
Reports to:
Manager, Database Validation or above
Responsible for:
N/A (Functional Management Role)
Job Overview Scope of Responsibility / Level of Oversight, Authority & Independent Decision‑Making:
Provides project leadership for the validation team to ensure the quality of assignments and adherence to timelines
Exercises high level of independent decision‑making
Performs tasks and initiatives with minimal guidance
Key Responsibilities The primary responsibilities of this position include, but are not limited to, the following:
Develops validation testing strategies for on‑prem and cloud‑based regulated and non‑regulated computerized systems in accordance with industry standards and regulations.
Provides guidance on validation approaches, best practices and analysis.
Manages and packages all SDLC Deliverables in preparation for system audits.
Mentors and coaches validation team to foster best practices and ensure high‑quality work.
Oversees validation projects, including: task assignment, resourcing and timely delivery.
Validates and tests applications built on cloud data storage or relational databases (Oracle, MS SQL), with a focus on data flow integrity in compliance with ALCOA+.
Analyzes business requirements and technical requirements to develop testable conditions and scenarios.
Designs and executes test cases to ensure system compliance, data integrity, accuracy and traceability throughout the Systems Life Cycle.
Validates clinical systems in compliance with GxP, GAMP, 21 CFR Part 11, and applicable regulatory guidelines.
Reviews, analyzes and creates test data, comprehends data mapping and interprets results to support validation efforts.
Creates Validation Package deliverables including Validation Plan, Traceability Matrix, Test Plan, Acceptance Test Scripts (Functional, UAT, Performance, Integration, Data Quality and Regression), and Summary Reports
Participates in risk assessments and impact analysis related to system changes.
Rapidly identifies critical validation areas when project scope or requirements change.
Builds reusable and modular validation components to support system scalability and change control.
Provides feedback on User and Functional Requirements Specifications to ensure requirements are clearly defined and testable.
Represents department on cross‑functional teams, projects, and GXP‑related problem resolution.
Differentiates between true system issues and evolving user requirements or configuration change
Conducts defect analysis and delivers precise, actionable insight to development teams to facilitate efficient issue resolution.
When roadblocks, defects, or scheduling challenges are encountered in testing, finds solutions to enable successful and on‑time completion of validation projects
Identifies ways to streamline processes in validation, while not compromising adherence to SOPs and GCP regulations
Qualifications Level of Education
Bachelor’s Degree required
Prior Experience
8+ years prior experience inclusive of computer systems validation required
5+ years relevant experience in Leading a Validation Team
Strong experience working with relational databases (Oracle, MS SQL) to ensure data integrity in compliance with ALCOA+
Prior experience working in a Life Science regulated industry required
Skills and Competencies
Strong knowledge of computer systems validation (SDLC, Agile methodologies)
Knowledge and understanding of Regulatory Guidelines for the use of computer systems required
Ability to research and analyze system requirements, develop alternatives, and implement solutions
Knowledge of web technology and cloud‑based systems
Strong communication skills, both verbal and written
Proven analytical, problem solving and technical skills
Ability to absorb and retain information quickly
Advanced knowledge of Excel
Comfortable working in fast‑paced environments with evolving priorities
Self‑starter with the ability to work independently and in cross‑functional teams
Excellent interpersonal skills
Highly organized and result‑oriented
Keen attention to detail
Additional Requirements
Able to work effectively as an onsite or remote worker
Willing to travel to meetings as needed occasionally. Advance notice will be provided.
Must be highly fluent in English
Seniority Level Mid‑Senior level
Employment Type Full‑time
Job Function Information Technology and Project Management
Industries Pharmaceutical Manufacturing, Biotechnology Research, and Information Services
#J-18808-Ljbffr