Validation Support

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

EEO Employer

Apex Systems is an equal opportunity employer. We do not discriminate or allow discrimination on the basis of race, color, religion, creed, sex (including pregnancy, childbirth, breastfeeding, or related medical conditions), age, sexual orientation, gender identity, national origin, ancestry, citizenship, genetic information, registered domestic partner status, marital status, disability, status as a crime victim, protected veteran status, political affiliation, union membership, or any other characteristic protected by law.