Validation & Engineering Group, Inc. (V&EG) is a leading services supplier who provides solutions for the Pharmaceutical, Biotechnology, Chemical, Food, and Medical Devices industries in the following areas: Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services.

We are seeking a talented, dedicated individual committed to work under the highest ethics standards for the following position:

• Master Maintenance Packages Owner

Qualifications:

• Bachelor's Degree in Science or Engineering.
• Minimum of 3 years of experience in direct pharmaceutical, medical device or biotechnology industries.
• Experience in direct process / manufacturing areas.
• Must be fully bilingual (English / Spanish) with excellent oral skills.
• Must be proficient using MS Windows and Microsoft Office applications.
• Strong knowledge in cGxP and regulatory guidance as well as understanding of how they are applied to regulatory compliance.
• Strong knowledge (according to related area).
• Technical Writing skills and investigations processes.
• Available to work extended hours, possibility of weekends and holidays.

Requirements:

• Drug substance manufacturing and asset engineering experience to complete the following responsibilities and deliverables associated with the execution and completion of the Maintenance Master Package (MMP) process for capital project assets and systems:

  Role - MMP Owner:

• Executes MMP activity workflow to ensure adherence to schedule, data quality, and outcome aligns with overall asset MMP requirements supporting asset production readiness.
• Supports the MMP project manager with the coordination, scheduling, and tracking of MMP activities associated with equipment and systems in workflow.
• Executes MMP activities and ensures completeness of data throughout the execution and prior to upload in CMMS including:
  • Generate work orders as necessary. Reviews Instrument Data Sheets and Job Plans for accuracy and completeness; provides to SO.
  • Create Job Plans and Preventative Maintenance schedules. Completes the population of asset data in template forms.
  • Load or update asset data in CMMS.
• Completes asset recommended spare part assessment utilizing Spare Part Assessment Tool (SPAT) to establish the recommended spare parts list. Partner with MRO spare parts resources in evaluating spare part availability and assignment in Maximo.