Associate Validation & Qualification - Level 3

Description

Oversee and coordinate well-defined multi-disciplined projects from inception to project completion in support of site operations ensuring safety, regulatory compliance, company standards, operational requirements and business needs.  Coordinate information across the project team to facilitate project execution.  Prepare routine project status reports.  Apply engineering principles and methodologies to project and support work.  Identify technical problems and develop problem-solving solutions.
•    Apply cGMP principles for the workplace.  Incorporate cGMP and regulatory compliance into all assigned project scopes, design and construction activities.  Promote safety within the workplace by following site safety procedures.  Incorporate safety into all assigned capital projects. Participate in HAZOP Operational Readiness Reviews as appropriate.  
•    Coordinate and oversee development of assigned project design documents. Select A&E firms to perform engineering design.  Coordinate and review work with outside A&E firm relating to designs and deliverables (drawings, specifications, etc.). Coordinate team review of designs. Coordinate design meetings, transmittal of information and document review. Define and document team decisions.
•    Prepare project estimates for design, equipment, installation, labor, materials, and other related costs.  Work with Purchasing to prepare bid packages for construction and facilities expansion.  Prepare project forecasts and schedules and tracks costs. 

•    Oversee assigned project contract work.  Review and approve project contractor bids, request for information, submittals and change requests.  Inspect work progress to ensure conformance to established drawings, specifications, schedules, and safety regulations.  Assure contractors receive necessary orientation and training.  
•    Provide technical assistance to site operating groups through investigations, equipment assessments, and design support.
•    Has basic general technical knowledge, and specific discipline knowledge.
•    Have good verbal and written skills. Can articulate issues and solutions to the team. Can produce effective project reports and presentations.
•    Can effectively interact and collaborate with team members. Demonstrates respect for others.  Encourages team participation.
•    Capable of simultaneously managing multiple assignments.  Organizes daily activities to assure timely completion of assignments.  Flexible and responsive to changes.
•    Can analyze problems and provide support in determining appropriate corrective and preventative actions
•    Ability to review, approve, and manage contract services.  Assure conformance to established drawings, specifications, schedules, and regulatory/safety requirements.