- Lead / manage the execution of capital projects pursuant to project requirements.
- Conform to industry standard quality and regulatory expectations ensuring change controls are appropriately used when necessary. Proactively identify engineering problems or opportunities, and apply technical expertise to develop and present feasible solutions
- Work with outside contracting firms to bring projects from the conceptual design stage to execution ensuring completion within time and budgetary constraints while delivering a high quality end product
- Coordinate and review contractor and vendor activity and interface with personnel as required ensuring all company standards are maintained
- Ensure thorough engineering standards for project execution, design, equipment standards, safety, and cost control
- Direct procurement of required equipment and materials for a specific project, including fabrication, off-the-shelf components, and custom components
- Maintain open channel of communication to manage expectations regarding project scope, timeline, progress, and required customer feedback
- Manage testing activities for projects, including mechanical and automation commissioning, installation and operational qualification
- Ensure project documents are created accurately in a timely manner and review vendor / contractor documents including datasheets, drawings, specification documents, test documents, or other project-specific documents
- Respond to and research engineering problems for timely resolution to include leveraging vendor or manufacturer expertise to solve equipment and facility related problems
Required Skills & Abilities:
- Demonstrated leadership, interpersonal, technical aptitude, and problem solving skills
- Must be flexible and able to manage multiple priorities and projects
- Must be results driven and goal oriented with the ability to manage risks
- Hands-on active program management style while maintaining awareness of team activities
- Excellent organizational, verbal and written communication skills with the ability to effectively communicate within cross-functional teams and to upper management
- Ability to organize and present technical overviews to engineering staff, cross functional departments, and upper management
- Maintains effective relationships across functional units gaining their trust and respect
- Puts accomplishing the goals of the group ahead of accomplishing individual goals
- Openly shares knowledge/information needed to accomplish a task or solve a problem
- Exhibits professionalism and sets an example for others to follow
- Self-starter and detail oriented
- Ability to manage commitments for self and the team while displaying an eagerness to learn and continuously improve
- Proficient knowledge of pharmaceutical cGMP requirements and systems
- Knowledge of regulatory requirements for manufacturing of pharmaceutical products
- Strong project management capabilities; cost estimation; project scheduling; capital equipment specification, procurement and qualification; hands on equipment problem solving ability; experience in process validation; experience in cGMP manufacturing environment
- Prior experience managing outside contracting firms
- Proficiency with MS Project, MS PowerPoint, MS Excel, MS Word, Visio, and SharePoint and other most common applications for analysis/problem resolution
- Ability to effectively communicate requirements to vendors and manufacturers
- Insight into customer processes and operational needs
- Problem-solving mentality to creatively troubleshoot unexpected process or equipment issues
- Strong interpersonal communication and leadership skills
- Must be energetic, positive, detail-oriented, and self-motivated
- Project Management Professional (PMP) certification is a plus
- AutoCAD proficiency is a plus
Working Conditions & Physical Requirements:
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is regularly required to:
- Experience prolonged sitting, some bending, stooping and stretching.
- Use hand-eye coordination and manual dexterity sufficient to operate a keyboard, photocopier, telephone, calculator, and other office equipment is required.
- Attendance is mandatory.
- Bachelor’s degree preferably in Engineering, Microbiology, Chemistry, Biochemistry, Business, or related field, and
- 8 years’ relevant project management experience.
- Relevant project management experience in a biotechnology or pharmaceutical development and manufacturing environment managing a portfolio of multiple complex programs.
- MBA or Master’s degree.
- Experience with FDA/regulatory audits.
- Strong experience with quality systems.
- Experience in a cGMP facility or working with FDA regulations.
- Certifications in Project/Risk Management (PMI-PMP, PMI-RMP) or Lean Six Sigma and demonstrated practical experience.
- Previous Accounting/Finance/Budgeting experience
- AutoCAD proficiency is a plus
We are an equal opportunity and affirmative action employer. All qualified applicants will receive consideration without regard to race, color, national origin, sex, gender identity, sexual orientation, religion, disability, protected veteran status or any other characteristic protected by applicable federal, state or local law.
If an accommodation to the application process is needed, please e-mail FDBTHR@fujifilm.com or call 979-431-3528.