GENERAL SUMMARY

Manages engineering projects associated with all domestic company sites by coordinating the complete project lifecycle: definition, design, procurement, construction, commissioning, validation and handover. This includes leading project requirements analysis, scope development/consensus, proposal presentation, design development, placement of contracts, and management of contractors, scheduling/tasking of internal resources, control of project schedules, budgets, and issues management.

REPORTING RELATIONSHIP

Reports To: Director, Engineering Services

Direct Reports: Manager, Project Management

RESPONSIBILITIES

Process Analysis & Project Definition

Achieves project scope and definition agreement from department managers to internal subject matter experts and other resources as required for each project.

Facilitates project requirement analysis workshops to determine the scope of each project. Develops user requirement specifications as required. Coordinates approval by relevant company departments.

Facilitates definition of requirements for complex equipment (e.g. lab sample handling and testing equipment) and IT systems as required. Facilitates completion of investigative studies for complex equipment and functional descriptions for IT systems.

Facilitates further design definition with internal staff to determine the required activities in each work area: space requirements, equipment requirements, utilities requirements, material and work flow diagrams, space adjacencies, etc.

Oversees architectural and engineering work to develop preliminary floor plans and other preliminary design details. Coordinates approval by relevant company departments.

Formulates preliminary project implementation plans and determines project budgets and schedules.

Facilitates development of project justification with input from project sponsors.

Develops Capital Expenditure Proposals and presents to senior management for approval.

Project Coordination and Management

Mobilized and coordinates internal resources against project schedules

Oversees architectural and engineering work on design development, including development of all construction drawings and related engineering documentation. Reviews and approves drawings and documentation. Coordinates approval by relevant company departments

Coordinates and facilitates the preparation of tender documentation for construction contractors and leads the contractor selection process

Develops or assists with development of Request for Proposal (RFP) documentation for equipment to be purchased by the company

Oversees order of company equipment. Arranges for Quality Assurance (QA) to conduct vendor pre-qualification audits for specialized equipment.

Oversees the work of contractors during construction and commissioning to ensure that time, quality and cost requirements are met. Addresses issues as required.

Oversees validation activities including development, approval and execution of validation plans and protocols

Oversees raising of purchase orders and approval of invoices are required

Monitors & reports progress, quality and cost parameters of all projects

Operations & Maintenance Support

Ensures that operations staff is aware of operational and maintenance requirements for new equipment, providing formal handover documentation as required. Works with internal staff to ensure timely and satisfactory resolution of any issues.

Facilitates project teams consisting of both internal company domestic staff and external contractors (architects, engineers, construction firms etc.).

Ensures that finished projects satisfy the requirements of the business and comply with FDA (Food and Drug Administration), GHA (German Health Authority) and other regulatory agency requirements.

Other job-related occasional duties such as assigned.

JOB SPECIFICATIONS

Education

BA degree in Engineering. Mechanical, Industrial, Chemical disciplines or related field or an equivalent combination of relevant work experience and education required equaling up to a minimum of ten (10) years' experience

Experience

Minimum of five (5) years' experience in project management, including design, construction, commissioning and validation of facilities and systems in a Life Sciences Industry environment required

Working Conditions

Understands complex problems to collaborate and explore alternative solutions

Ability to formulate complex and comprehensive materials such as authoritative reports of major scope and impact, etc. and/or to make formal presentations

Ability to make decisions which have significant impact on the immediate work unit and monitor impact outside immediate work unit

Overnight travel required up to 80% of the time

Fast paced environment with frequent interruptions