Computer Software Validation Engineer

Responsibilities:

Update or create, application/software/IT use case documents and requirement specifications.

Define technical project scope and objectives.

Application/software/IT functional specification documents.

Commissioning documents (i.e. unit tests, software verification tests).

Independently provide for the delivery of manufacturing modules for an ERP system by: o Configuration of parameters, forms, and workflows in the software to define application behavior.

Lead application demonstrations and work with end-users to insure user requirements are met.

Execute commissioning; support validation team's installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ) activities.

Function as an application level system administrator.

Collaborate to produce Standard Operating Procedures (SOPs) and training materials; conduct training for SOPs.

Develop reporting tools to support quality assessment.

Practice and stay current with ISPE GAMP best practices, FDA GxP regulations, and applicable ISO standards.

Coordinate activities with external consultants.

Monitor project progress by tracking activities; resolving problems; publishing progress reports; recommending actions.

Requirements:

Must maintain company quality and safety standards.

Must maintain company values Minimum Work Experience/Educational Requirements.

Ability to demonstrate excellent interpersonal and communication skills, both written and verbal.

A Bachelor's degree in Computer Science, Information Systems, or a related field of study.

3+ years of experience in one or more of Applications Engineering or Configuration, Applications Delivery, Software Development, or Software Requirements Analysis.

3 + years of experience in developing and delivering software solutions for an ERP system such as provided by: Sage, SAP, Oracle, Microsoft Dynamics NAV.

Able to demonstrate the experience to independently carry out tasks under the direction of CSA staff.

Able to demonstrate an understanding of FDA 21 CFR Part 11 and related regulations associated with biopharma, pharma, or medical device industries.

Able to demonstrate an understanding of manufacturing best practices like those described in ISPE GPGs.

Ability to comprehend technical information related to biotech equipment, computer and network hardware, and the associated regulatory expectations relating to them.

Ability to work under specific time constraints.