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Validation Specialist

Date: Apr 19, 2021

Location: Philadelphia, PA, US

Company: Spark Therapeutics

Join the Spark Team

 

We were born of innovation, springing from the curiosity, imagination and dedication of remarkable scientists and healthcare visionaries. Our shared mission is to challenge the inevitability of genetic disease by discovering, developing, and delivering treatments in ways unimaginable – until now.

 

We don’t follow footsteps. We create the path.

 

 

 

As part of an overall cross-functional Commissioning, Qualification and Validation (CQV) approach to laboratory equipment/instruments the Validation Specialist will be involved in all aspects of CQV within a US and EU GxP regulated environment.

Under the general guidance of the Validation Leader, the Validation Specialist will independently manage contractors, the overall development, implementation of GLP/Non-GLP equipment/instruments, and system lifecycle documentation.  This includes: Validation Plans, User Requirements Specifications, Design Qualifications, Testing Protocols (IQ/OQ/PQ/DQ), Validation Summary Reports, Revalidation & Periodic Reviews, SOPs, Change Control Documentation and Risk assessments.

 

 

 

Responsibilities

Describe the essential daily job functions and include % of time spent on each.

% of Time

Job Function and Description

45

• Lead the CQV planning, development, and implementation of GLP and Non-GLP laboratory equipment/instruments and utilities for all levels of projects.

• Review/approve and execute the validation documentation for facilities, manufacturing and laboratory equipment, shipping, utility systems and process equipment including cleaning validation.

• Manage validation contractor activities for projects and ongoing operations.

• Represent validation during the creation of Validation Strategy Documents and other project related documentation

25

• Initiate and participate as appropriate in associated change control requests, deviations, CAPAs and equipment acquisition documentation

• Responsible for all projects assigned.  May act as an advisor to team members to meet schedules or resolve technical or operational problems.  Is cognizant of schedules, and performance standards in how they relate to work assigned.

20

• Works under consultative direction to perform corrective actions to address validation discrepancies and identified measurement problems.  Work checked through consultation and agreement with others rather than by formal review of superior.  Champion continuous improvements by developing best and proven practices in the department based upon current industry, US and EU guidelines.

• Ensures schedules, and performance requirements are met.

10

• Leads the development and maintenance of validation related Master Plans, SOPs, work instructions, and forms.

• Will represent function on specific projects, conduct briefings and technical meetings for internal and external representatives, as needed.

 

 

 

Requirements

• BS degree in engineering or a life sciences field is required

• A minimum of 7-10 years of experience in validation within a GLP regulated environment (FDA, EU, MHRA)

• Demonstrated technical project management experience to develop project goals, deliverables and timelines.

• Proven experience developing full validation documentation and testing protocols (IQ/OQ/PQ/DQ) for GLP laboratory equipment/instruments.

• Demonstrated working knowledge of Good Engineering Practices, ASTM E2500, USP 1058, 21CFR Part 11, GAMP5 as they relate to equipment/instrument qualification.

• Strong working knowledge of GxP compliance as well as USP, EP, ICH and FDA guidelines

• Previous work experience with automated lab systems and robotics is highly desirable


Nearest Major Market: Philadelphia