Senior Validation Engineer

Verista Wayne , PA

Posted 4 days ago

Who are we:

Looking for an exciting opportunity at a fast growing, employee-oriented company? Veristas 500+ experts team up with the worlds most recognizable brands in the life science industry to solve their business needs. Whether its compliance, quality management, verification, validation, automation, IT infrastructure, data analysis, manufacturing, or packaging, we deliver solutions that are right the first time.

Veritas experts include SMEs across the spectrum of pharma, medical devices and biotech industries. As a result, were uniquely capable of offering transformative, integrated solutions, new perspectives, and consistent results.

Our ability to grow is driven by world-class people who thrive in a team environment and share our mission to enable our clients to improve the quality of patient healthcare worldwide. Our talented and dedicated professionals are committed to making an impact every day.

We deliver solutions that are right the first time.

Typical Responsibilities Include:

Leads and performs risk-based validation of GxP systems, develops validation documents using defined CSV process, and communicates project progress throughout the system lifecycle.

Validates system implementations, system upgrades and creates system documentation in accordance with computerized system validation plan and protocols. Deliverables will include Validation Plan, User and Functional Requirements, Requirements Traceability Matrix (RTM), Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ) and Validation Summary report. Facilitates verification and validation activities such as User Acceptance Testing (UAT), test execution, documentation review, and approval. Experience with systems like Data Lake, ServiceNow, JDE and Veeva Systems like MedComms, RIM, eTMF and VeevaDocs will be considered a plus.

Requirements

Responsible and accountable for the development and delivery of a complete validation package:

User Requirements Specification (URS), Validation Plan (VP), Installation/Operational/Performance Qualification Protocol (xQP), Installation Qualification (IQ), Functional Requirements Specification (FRS), Operational Qualification(OQ), Performanace Qualification (PQ), Traceability Matrix (TM), Validation Summary Report (VSR), Configurations Specification (CS), Administration and User SOPs, Work Instruction (WIs), or Forms and exceuting these protocols, if needed

Preferred:

  • Bachelors Degree in Computer Science, Information Technology, or related discipline.
  • 5+ years of experience in the Information Technology field.
  • 3+ years of pharmaceutical GxP system validation experience.
  • Excellent communication and technical documentation skills.
  • Strong attention to detail and quality oriented.
  • Strong knowledge of processes and applications related to Clinical Operations, Medical Affairs, Clinical Data
  • Strong knowledge of procedures and best practices related to FDA Regulations, EU GMP Annex 11,
  • 21 CFR Part 11, Computer System Validation, GAMP 5, cGxP (cGCP, cGLP, cGMP) practices, and
  • System lifecycle (SLC) experience in a regulated environment.

Management, Clinical Science, Biostatistics, Lab, Drug Safety & Pharmacovigilance.

other regulations governing drug development and commercialization.

Benefits

Because employees are the key to our success, Verista offers strong benefits and incentives including:

  • Health, Dental, and Vision Insurance
  • 401(k) Retirement Plan with a company match
  • Paid Time Off Pay
  • Tuition Reimbursement
  • 9 Company Paid Holidays
  • Paid Long Term & Short Term Disability Insurance
  • Training and Development
  • Paid Maternity Leave and Parental Leave
  • Travel Bonus
  • Employee Referral Program
  • Tuition Reimbursement
  • Marriage Leave
  • Bereavement

*Verista is an Equal Opportunity Employer

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Senior Validation Engineer

Verista