Summary: The Associate Director - Project Engineering is responsible to ensure deliverables for the capital investments program are being met and are in line with stakeholders and company expectations. The Associate Director - Project Engineering will oversees the day-to-day capital projects activities, manage the local capital project team, delivery of local capital approved projects and strategic capital projects. Projects include: simple scope equipment procurement to more complex capital project scopes involving facility design/ construction/modification, efficiency improvements, systems sustainability and quality/safety enhancement.
- Direct supervision and leadership of cross-functional individuals and groups within the organization.
- Provide mentorship to principal project managers, project managers, project engineers and people within the project engineering organization at the Texas operations.
- 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.
- Provide recurrent status and updates to the engineering leadership team and site leadership in regards to projects, schedules, and budgets.
- 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 product.
- Directly responsible of managing multiple Capex programs, including local capital projects and strategic company projects.
- 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.
- Develop and manage the capital project budgets and ensure company remains within the budget constraints.
- Manage testing activities for projects, including mechanical, electrical 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.
- Track and report on project performance, metrics and KPIs.
- Keep project management software and dashboards updated.
- Actively review projects status, communicate progress, and constrains.
- Performs other duties as assigned.
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.
- Self-starter and detail oriented.
- Knowledge of regulatory requirements for manufacturing of pharmaceutical products.
- Strong project management capabilities; scope generation; 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, Smartsheets 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
- Support and supervise activities outside normal business hours as needed, during night time and weekends
- 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
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, standing, bending, stooping, climbing and stretching.
- Use hand-eye coordination and manual dexterity sufficient to operate a keyboard, photocopier, telephone, calculator, and other office equipment is required.
- Be exposed to noisy environments.
- Travel time up to 10%.
- Support company activities 24/7.
- Attendance is mandatory
- Bachelor Degree in Engineering/Construction Science or equivalent or related field; and
- Ten (10) years of relevant project management experience in a biotechnology or pharmaceutical development and manufacturing environment managing a portfolio of multiple complex programs with at least eight (8) years in the pharmaceutical sector.
- Experience in a cGMP facility or working with FDA and/or EU regulations.
- Previous Accounting/Finance/Budgeting experience
- MBA or Master's degree.
- Experience with FDA/regulatory audits.
- Strong experience with quality systems.
- Certifications in Project/Risk Management (PMI-PMP, PMI-RMP) or Lean Six Sigma and demonstrated practical experience.
- Engineering Documentation Management
- AutoCAD and Revit proficiency
- Project Management Professional (PMP) certification