Summary:
DPS Engineering is looking for a knowledgeable DeltaV Validation Engineer to work with a BioPharma client in the Boston, Ma area. This individual will be responsible for developing and executing validation protocols for a DeltaV project and executing validation activities in the field. Ideal candidates should have a strong understanding of GMPs and experience providing engineering support in highly regulated or pharmaceutical/biotech facilities.
Core Responsibilities:
Expertise in developing the validation protocols and summary reports.
Must be able to draft summary reports for approval.
Development of CSV and equipment specifications and executing Computer System Validation, System Development Life Cycle (SDLC) and other pharmaceutical equipment/system commissioning/validation (IQ/OQ/PQ) protocols in accordance with Good Engineering Practices, GaMP, local SOPs, industry best practices and other industry related guidance documents.
assess the impact of changes to cGMP equipment/systems and methods and establish the applicable Validation Plan to ensure the validated status following changes.
Experience in technical writing, report generation of testing methodologies of automated systems.
Qualifications:
Bachelor’s Degree in Computer Science or Engineering discipline.
5+ years of demonstrated experience in cGMP automation/computerized systems, quality and compliance areas in the pharmaceutical industry.
Thorough understanding of industry standards and best practices for computer system validation.
Must have demonstrated knowledge of DeltaV systems.
Position requires a broad range of experience with validation of equipment.
ability to interact with internal and external customers in a professional and helpful manner.
Excellent verbal and written communications skills, ability to explain system issues clearly and concisely.
Must be able to work independently and as part of a team to deliver solutions on time and according to schedule.
