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Merck · 1 day ago

Sterile Specialist, Engineering (Onsite)

Rahway, NJ

Full-time

Onsite

Entry, Mid Level

$87K/yr - $137K/yr

2+ years exp

Merck is a leading pharmaceutical company seeking a Sterile Specialist to provide on-site engineering support at their Rahway, NJ facility. The role involves maintaining facility and manufacturing equipment, supporting quality engineering efforts, and managing capital projects to ensure compliance with GMP and safety standards.

BiotechnologyHealth CareMedicalPharmaceutical

Comp. & Benefits

No H1B

Responsibilities

Maintain facility, utilities, and manufacturing equipment in accordance with GMP and Safety requirements

Apply Reliability Maintenance best practices to ensure timely availability of clinical and development batches

Troubleshoot equipment and interact with Partner Groups such as GES and OEMs

Provide support for Quality Engineering and capital projects, interfacing with site engineering and maintenance groups

Support the full equipment validation lifecycle by preparing, executing, and approving protocols

Manage equipment/system changes and perform periodic reviews

Evaluate deviations, issue Quality Notifications, and perform investigations to identify root causes and corrective actions

Maintain GMP documentation such as engineering drawings and equipment database tracking

Support mechanical aspects of clinical operations and coordinate activities executed by maintenance personnel

Manage purchase orders, budgets, and asset depreciation

Support capital project administration and coordinate installation and upgrades of new capital equipment

Act as a Subject Matter Expert for regulatory interactions when needed

Support the sterile validation program and coordinate field execution activities

Qualification

CGMP GuidelinesQuality EngineeringSterile Drug ProductEquipment MaintenanceSAP Plant MaintenanceCapital ProjectsTroubleshootingEffective communicationAdaptabilityPersonal InitiativeEffective organizational skills