Project Manager - Engineering
San Diego Metro Area, CA
Provides project management and engineering services to Manufacturing, Product Development, Facilities, and other partner groups. Responsible for full project lifecycle development and managing projects on schedule and within budget while engaging customers and owners across multiple functions. Key contributor to the development of PMO standards.
Experience in the design, construction, commissioning, and operation of:
o Pharmaceutical-Biologics Manufacturing Systems: Chemical Synthesis, Fermentation/Cell Culture, Purification, Media/Buffer Preparation Operations, or Fill-Finish Operations.
o Pharmaceutical-Biologics Manufacturing Support Systems: Clean Steam, Water-For-Injection, Clean-In-Place (CIP), Steam-In-Place (SIP), and Component Preparation.
o Industrial Manufacturing Facility Systems: Plant Steam, Refrigerated/Chilled Water, Compressed Air, Process Gases (O2, N2, CO2), and Reverse Osmosis/Deionized (RO/DI) Water.
Full responsibility over effective management through full program and project management lifecycle.
Define and manage project/initiative scopes, execution resources (i.e. people, funds), timelines/schedules as well as indirect impacts on areas and/or partner groups.
Author and implement project management process guidance documents.
Manage the design, procurement, installation, start-up, and commissioning of pharmaceutical manufacturing facility systems and equipment.
Verify and/or execute Factory Acceptance Test (FAT), Site Acceptance Test (SAT), and/or commissioning protocols for pharmaceutical systems and equipment.
Assist Quality Assurance and/or Validation personnel during the execution of Installation-Operational Qualification (IOQ) protocols for pharmaceutical systems and equipment.
Work with and mentor junior project managers in developing new skills and career paths.
The qualified candidate will possess the following:
BS in Chemical Engineering, Mechanical Engineering or Manufacturing Engineering with 8-10+ years OR;
MS with 6-8+ years experience OR;
A minimum of 5 years overall direct experience with process and project engineering in pharmaceutical/biotech manufacturing.
A minimum of 10 years direct experience in project management and planning with 5 years of GMP related project experience.
PMP Certification preferred.
Application of PMI principles required.
Development and/or management of a PMO preferred.
Experience working with aseptic emulsion and/or filling equipment preferred.
Operational Excellence experience is a plus.
Experience developing and managing to corporate project management guidelines.
Strong organizational and teamwork skills.
Ability to influence individuals without having direct authority over them.
Creative problem solving skills.
Excellent written and oral communication skills are a must.
Advanced schedule management in Microsoft Project a plus (resource loaded Gantt, critical path/chain).
PC literacy required (Microsoft suite).
Must be able to read and interpret engineering and CAD documents.
Travel may be required (5-20%).