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Sr. Validation Specialist

Date: Apr 3, 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/analytical instruments the Sr. Validation Specialist will be involved in all aspects of CQV within a US and EU GxP regulated environment at multiple Spark sites.

 

Under the general guidance of the Validation Leader, the Sr Validation Specialist will independently manage the overall development and maintenance of GxP and non-GxP laboratory/ana;ytical instrument and implementation and system lifecycle documentation for all Spark sites.  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

 

45%       Supports the Spark sites as the Validation SME in the planning, development, and implementation of laboratory/analytical instruments.

Review/approve and execute the validation documentation for laboratory/analytical instrument and associated enterprise systems.

  Authors and interprets validation reports that reflect the validations performed with and without contractor support.

                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.

 Directly participates in establishing and administering many centralized functional projects.  Is cognizant of budgets, 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.

Oversight of CQV Contractor(s).

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 GxP regulated environment (FDA, EU, MHRA)

• Experience working in a GMP and GLP environment is required with understanding of USP, EP, ICH and FDA guidelines.

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

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

• Working knowledge of enterprise systems (e.g. Lab-X, NuGenesis, etc) as they interface with instruments.

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


Nearest Major Market: Philadelphia