Senior Project Engineering Manager

Overview

Summary:  The Sr. Project Engineering Manager, under the supervision of the Director of Engineering, will be responsible for leading a team and overseeing project engineering activities such as the preparation, coordination and monitoring the implementation of engineering projects including the development of any specifications and infrastructure requirements, submittals and RFIs revision, design involvement with A&E firms, project documentation review, contractors and/or vendor coordination, field progress inspection and project closeout documentation on behalf of the different facilities at Fujifilm Diosynth Biotechnology Texas (FDBT). Assigned projects may be related to new product introductions, local capital projects and/or strategic projects as dictated by the business needs. This position will work closely with facilities, manufacturing resources, CAPEX team, validation, QA/QC, contractors, and other functional areas to ensure projects change controls are properly executed, coordinated, and followed as the main system for documenting changes to the facility, utility and/or equipment as applicable. This position will be responsible for the FDBT drawing management program as well as supporting maintenance strategies development, SOP’s development and equipment commissioning/qualification activities as required.  

External US

Essential Functions: 

• Lead project engineering staff on the implementation of local and/or strategic engineering projects in support of but not limited to facility infrastructure modifications, site utilities improvements, new equipment installation, and/or NPIs.  
• Facilitates and support the resolution of technical problems during design/construction phase. 
• Lead, coordinate, manage, and monitor the implementation of team assigned engineering projects. 
• Lead and develop equipment/system specifications, identify infrastructure requirements, and perform capability assessments as required for the team’s assigned projects. 
• Review, markup and ensure project documents such as specifications, submittals, RFIs, test documents, drawings and/or other project specific documents are created and documented accurately. 

• Responsible for leading the generation of the change controls associated with the assigned projects conforming with industry standards, quality, and regulatory expectations. 
• Responsible for the FDBT drawing management program.  
• Work with outside contracting firms to bring projects from the conceptual design stage to implementation and providing solutions to technical problems that may arise during the life of the project. 
• Lead coordination of project activities with A&E designers, General Contractors, and vendors.  
• Inspect field progress of building construction, equipment/systems modifications and/or improvements. 

• Establish the methods by which all field tests are administered and monitor the quality of those tests. 
• Actively monitor team projects status and communicate progress and constrains. 
• Responsible for tracking and ensure completion of team’s projects punch list items. 
• Liaison with CAPEX team for the implementation of capital projects. 
• Responsible for the oversight of contractors during team’s projects implementation as required. 

• Works with QA/QC to ensure proper testing, inspection and release after completion of project implementation. 
• Support equipment IQ/OQ/PQ or any other validation/commissioning startup activity as required. 
• Ensure new equipment operates in compliance with required EHS, regulations and codes. 
• Lead the development, edit and/or review in collaboration with Facilities SOPs, P&IDs and maintenance procedures for new equipment and/or systems. 
• Communicate efficiently with management, contractors, suppliers, OEM providers as well as internal equipment owners and operators for a successful operation of the FDBT facility.   

• Able to work with other contractors, manufacturing, validations and quality control personnel regarding changes or improvements to the systems. 
• Ensure compliance, as set forth in internal quality protocols and SOPs including cGMP and FDA regulatory guidelines, within the areas of responsibility, and document out of specification conditions with deviations, CAPAs and Change Controls as appropriate. 
• Continuously stay current with assigned SOPs and keep up to date training file ensuring compliance with all applicable Standard Operating Procedures. 
• Ensure a safe work environment is maintained through adherence and compliance with safety guidelines, policies, site procedures and job performance qualifications. 
• Demonstrate continuous personal pursuit to increasing job knowledge, proficiency in technical understanding, and problem-solving abilities.  

• Maintain a positive, professional, and customer-oriented attitude. 
• All other duties as assigned. 

Required Skills & Abilities: 

• Identify engineering problems and/or opportunities and apply technical expertise to develop and present feasible solutions.  

• Knowledge and understanding of the techniques and procedures of engineering project management as well as OSHA regulations and safe work practices. 
• Demonstrate leadership, technical aptitude, and problem-solving skills. 
• Must be flexible and able to manage multiple projects, priorities, and tasks. 
• Must be results driven and goal oriented with the ability to manage risks. 
• Knowledge and understanding using P&IDs, equipment manuals, specifications, SOPs, and be able to use proper judgment when implementing projects. 

• Strong analytical and problem-solving skills. Possess or have the ability to apply these skills to resolve technical problems and to gain knowledge with respect to the operation of utility/process systems. 
• Strong project management capabilities; scope definition; project scheduling; equipment specification, procurement, and qualification. 
• Must be able to develop, and draft operational procedures and maintenance procedures for technical (utilities/process) equipment using the OEM manual and system knowledge. 
• Possess or have the ability to gain knowledge of FDA, OSHA, EH&S, EPA, and state of Texas requirements. 
• Knowledge of regulatory requirements for manufacturing of pharmaceutical products. 

• Must be able to use project management software such as Microsoft Project. Proficient with MS Office products (Word, Excel, Outlook, PowerPoint, Visio). 
• Strong written and verbal communications 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. 
• Be self-starter, self-motivated, detail oriented and possess interpersonal skills. 
• Puts accomplishing the goals of the group ahead of accomplishing individual goals. 

• Support and supervise activities outside normal business hours as needed, during nighttime and weekends. 
• Ability to learn quickly and work effectively with little supervision when needed. 
• Desire to work in a fast paced, state of the art, alternately research and customized manufacturing facility. 
• Knowledge of bio-medical process equipment and site utilities highly desirable.  
• All other duties as assigned. 

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, walking, bending, stooping, and stretching. 
• Use hand-eye coordination and manual dexterity sufficient to operate portable tools, test instruments, as well as a computer keyboard, telephone, calculator, and other office equipment is required. 

• Have a normal range of vision. 
• The ability to regularly lift and/or move up to 50 pounds. 
• Climb ladders and stairs of various heights. 
• Be exposed to wet or humid conditions. 
• This position may require off shifts, weekends and/or holidays support.  

• Be exposed to outdoor weather conditions. 
• Be exposed to noisy environments. 
• Support company activities 24/7.  
• Attendance is Mandatory 

Minimum Qualifications: 

• Bachelor’s Degree in engineering or equivalent related field.  
• Ten (10) years of relevant project management experience with at least 3 years focusing on a pharma/biotech manufacturing facility or equivalent preferably regulated by FDA or any other regulatory agency and at least five (5) years of managerial experience or only three (3) if have previously been on a managerial/supervisor role within FDB.  

Preferred Qualifications: 

• Relevant project engineering experience in a biotechnology or pharmaceutical development and manufacturing environment managing a portfolio of multiple complex projects. 
• MBA or Master’s degree. 
• Certifications in Project/Risk Management or Lean Six Sigma and demonstrated practical experience. 
• Knowledge of Engineering Documentation Management. 

• Knowledge of quality management software specifically Trackwise. 
• AutoCAD, Revit, Bluebeam and/or Meridian proficiency is a plus. 

Salary:  Starting salary will be commensurate with education and experience.