Job Description

Must-Have Qualifications:

• Bachelor’s Degree in Engineering or Computer Science
• Minimum of five (5) years of relevant industry standards compliance experience in a pharmaceutical manufacturing environment.

Qualification Plusses:

• Master's Degree

Job Description/Responsibilities:

The primary responsibility is to provide validation services required for the successful delivery of IT & Automation projects.

Responsibilities Include:

• Provide validation and technical support through the preparation, execution, data analysis, and report writing for IV, OV, and PV protocols.
• Own Change Requests (CRs) related to project validation processes.
• Ensure compliance with technical requirements and approval of protocols and protocol data.
• Support the implementation of new systems and upgrades to existing systems by providing technical expertise and guidance.
• Lead cross-functional teams to meet goals and coordinate on regulatory requirements.
• Lead formal failure investigations into non-conforming items noted during testing activities.
• Manage and maintain a validated state for all automation items, including systems such as PAS-X, SAP, AMPSAP, Aveva PI, and computerized equipment like autoclaves, packaging assembly, filling cart washer, utensil washer, CIP/SIP formulation, etc.
• Participate in FAT, SAT commissioning activities for computerized equipment/systems.

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