Senior Computer System Validation (CSV) Automation Engineer
Pharmaceutical and Biotechnology Projects

Company: PES International 
Location: Greater Newburyport, MA 
Compensation: Commensurate with Experience
 
About this opportunity:

PES International is an international industry leader in providing commissioning, qualification, and automation services. We have an unrivaled knowledge based in these specialist areas from initial concept design through to commissioning and qualification of your facility. We’re actively building out our US presence and looking for talented team members to work with us in delivering critical project management consultancy expertise.

This role is a hybrid of CSV and Automation experience with hands on experience in implementation and validation of various computerized systems. The Senior CSV Engineer must have expeirence and knowledge in SDLC, Data Integrity, and general CSV requirements. This Senior CSV Engineer will work in a team environment with engineers and designers from partners and clients to provide services.

What we’re looking for:

• 5 years of experience in CSV in a highly automated pharmaceutical facility

• Extensive experience with validation of control systems (Emerson - DeltaV and Syncade), S88 Batch experience, recipe management and general development for DeltaV and Syncade 

• SDLC, Data Integrity experience required 

• Self-motivated with excellent communication skills to work with all levels of the organization and with external vendors and clients

• Exceptional critical thinking, data analysis, and problem solving skills

• Organizational ability to manage the overall documentation development and approval process including explanation and justification of document testing, content, and strategy from a quality and regulatory standpoint to facilitate acceptance and approval of the document by required signatories 

• Ability to adhere with project schedule(s) for all assigned activities

• Documenting the planning and design required to support the changes, approvals, and testing