Job Description

WE'RE HIRING AN ENGINEERING PROJECT MANAGER for our client based in Irvine CA

This position is the for the lead Project Management role to oversee and manage all aspects of the facility expansion to accommodate the installation of an aseptic filling line. The PM needs to have prior pharmaceutical construction/facility expansion Project Management experience, ideally with installation of an aseptic filling line. 

The PM will be responsible to asses risk, develop mitigation plans and to lead regular team meetings working cross functionally with the sites Manufacturing, Quality Assurance, Quality Control, Validation, Technical and Regulatory departments.  Interaction with colleagues outside the site and with customers will also be required.  The position will be required to report on a regular basis to the sites leadership team.  During the installation, the project must allow for manufacturing to continue in others areas of the plant in compliance with cGMP’s, regulatory standards, company policies and site processes. 

• The PM must have a strong background in buildout construction experience / clean room buildout experience and understanding of the process.  Experienced in IQ/OQ/PQ/DQ etc. FAT/SAT.  
• Review prints to pull detailed costs
• Coordination of construction flow to maintain the suite up during construction.  
• Ensure project is on time and meets set budget.  
• Review and ensure construction plans and approach makes sense.  
• Provide oversight of the entire project and ensure it’s on time, on budget and can meet the company objectives.
• Utilize effective project management tools.
• Ensures project plans are developed and maintained to meet the needs of the site and customer using appropriate risk mitigation strategies.
• Conducts routine project review meetings with team members to ensure timelines and projected costs are met.
• Assess risk and ensures that issues are discussed within the team and with the sites leadership.
• Drives project team accountability.
• ENSURES THAT THE PROJECT TEAMS INTERACT WITH THE SITES VALIDATION, MANUFACTURING, QUALITY, TECHNICAL AND REGULATORY DEPARTMENTS, AT APPROPRIATE LEVELS,  TO ENSURE EXECUTION OF PROJECT TASKS.
• Must be willing and able to work beyond the hours typically defined as a “regular” workday, which may or may not include weekends and holidays.

Qualifications

 EDUCATION:  

• BS/BA OR MS IN A RELEVANT DISCIPLINE.  
• Certifications:  Project Management Professional (PMP).

EXPERIENCE: 

• A MINIMUM OF 10 YEARS OF PHARMACEUTICAL CONSTRUCTION, DEVELOPMENT AND OR MANUFACTURING EXPERIENCE IN A CGMP ENVIRONMENT IS PREFERRED FOR THIS POSITION.  
• Previous experience with buildout construction / clean room buildout experience and understanding of the process.  Experienced in IQ/OQ/PQ/DQ etc. FAT/SAT. 
• Successful record of PM's jobs that meet timelines and budgets.

TECHNICAL:

• KNOWLEDGE OF CGMPS AND REGULATORY REQUIREMENTS AS RELATED TO THE MANUFACTURE, TESTING AND QUALITY OF PARENTERAL PRODUCTS.
• PROJECT MANAGEMENT TOOLS
• PROACTIVE PROJECT MANAGEMENT AND PLANNING
• Good interpersonal skills; collaborative approach; team player.
• Demonstrates attention to detail.
• Excellent organizational skills.
• Excellent written and verbal communication skills with the ability to interact with senior leadership and regulatory agencies
• Demonstrates self-sufficiency, able to work under limited supervision.
• Experienced in meeting the expectations and requirements of internal and external customers.
• Makes decisions of moderate complexity, sometimes with incomplete information and under tight deadlines and pressure. Makes sound decisions based upon a mixture of analysis, wisdom, experience, and judgment. Always acts with integrity.
• Deals with concepts and complexity comfortably – intellectually sharp, capable and agile.
• Understands when to inform, consult or escalate. Summarizes information succinctly and accurately and provides clear recommendations based on a combination of the information at hand and regulatory/procedural guidance.
• Presentation skills, computer literate (MS WORD, Excel, PowerPoint).
• Manage Resources to meet organizational goals
• Understand site financial systems
• Understand Safety concerns and maintain safe environment (5S, ergonomics)
• Ensure participation in company-wide knowledge exchanges

Additional Information

All your information will be kept confidential according to EEO guidelines.