Senior IOQ Validation Engineer

Apex Systems is seeking a Senior IOQ Validation Engineer to join our client, a global leader in the pharmaceutical industry. You MUST HAVE experience working with DeltaV systems and performing validation of cleanroom/manufacturing suites. This is starting as an 18 month contract, with potential to extend/convert permanent after that duration. It will be onsite in Andover, MA.

Support a multi-phase validation project involving the reconfiguration of manufacturing Suites 5 & 6 and implementation of ADC production. Responsibilities include:

• Equipment decommissioning and clean room updates
• Validation protocol generation, execution, and final certification
• Facility readiness and compliance documentation
• Summary reporting and archiving of validated materials

Requirements:

• Familiarity with cleanroom qualification and pharma equipment (Isolators, BSCs, skids)
• Knowledge/experience working with DeltaV systems
• Strong grasp of change control and impact assessment procedures
• Capable of executing smoke studies, HEPA certifications, and cleaning validations
• Proven record managing documentation for audits and regulatory review

Required Skills: MUST HAVE some type of knowledge/experience working with DeltaV systems. MUST HAVE prior pharma/biopharma industry experience. Very helpful to have experience with validation support for cleanroom/manufacturing suite upgrades - commissioning/decommissioning equipment, etc. This is an onsite role in Andover, MA so they will need to be local or able to move to the area very quickly (1-2 weeks). Relocation assistance is not provided.