Location: Athens,GA, USA
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.
* 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.
* 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.