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:

• Construction Quality Specialist - Readiness Support

Qualifications:

• Bachelor's Degree in Science or Engineering.
• Minimum of 8 years of experience in direct pharmaceutical, medical device or biotechnology industries.
• 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.
• Available to work extended hours, possibility of weekends and holidays.

Responsibilities:

Support the construction team with construction quality readiness functions. This includes supporting the delivery of equipment turnover packages as well supporting the facilities operational readiness tasks.

1. Skills and experience requirements for ETOP (Equipment Turnover Package):

   • Knowledge in reading construction drawings and P&IDs.

   • Knowledge in reading construction schedules in Primavera.

   • Knowledge in construction work, equipment and instrumentation installations.

   • Interaction with construction management documentation systems (Example: Procore).

   • Knowledge of process and facilities equipment and specifications.

   • Familiar with personal protective equipment usage and construction safety.

   • Good organizational, communication skills.

   • Good presentation skills.

   • Experience facilitating & managing team meetings and providing meeting minutes.

   • Comfortable engaging with team members, following up with tasks and deliverables.

   • Intermediate to advanced computer skills (MS Office Suite).

   • Familiar with documentation folder structures.

   • Familiar with commissioning and qualification protocols and execution.

   • Familiar with equipment turnover documentation requirements.

2. Skills and experience requirements for Facilities Operational Readiness support:

   • Knowledge of facilities & utilities equipment and specifications

   • Knowledge in reading construction drawings and P&IDs

   • Knowledge of commissioning and start-up activities

   • Familiar with commissioning and qualification protocols and execution

   • Familiar with management of change processes (MOC)

   • Familiar with CMMS systems (Example: Maximo)

   • Experience in completing/generating facilities asset data for CMMS – PM plans, spare parts, calibration plans

   • Knowledge in construction work, equipment and instrumentation installations

   • Familiar with personal protective equipment usage and construction safety

   • Good presentation skills

   • Experience facilitating & managing team meetings and providing meeting minutes

   • Comfortable engaging with team members, following up with tasks and deliverables.

   • Intermediate to advanced computer skills (MS Office Suite)

   • Familiar with equipment turnover documentation requirement.