SUMMARY

Highly motivated and highly skilled Engineering Leader with extensive automation, IT, and computer system validation (CSV) experience in the pharmaceutical and medical device industries.  Excellent project management, interpersonal, and people management skills along with a strong knowledge of statistics and data analytics

• Process automation and control
• cGMP compliance
• Aseptic Processing
• Environmental Monitoring
• Computer System Validation
• Change control
• Manufacturing IT Infrastructure design
• Excellent computer skills, MS Office, Oracle, PL/SQL, Minitab
• Data Analytics
• Excellent oral and written communications skills
• System Development Life Cycle (SDLC)
• Change Management
• Project Management
• People Management
• Systems Engineering

PROFESSIONAL EXPERIENCE

Confidential, Malvern PA

Controls and Automation Engineer / Project Manager

Responsibilities:

• Manage electrical and automation capital projects for Confidential globally.
• Prepare capital appropriation requests for electrical and controls projects for Confidential worldwide.
• Provide project management leadership for approved projects.
• Perform plant assessment and propose capital projects aimed at improving safety and efficiency, and addressing equipment obsolescence.
• Establish standards for electrical and controls equipment across all Confidential plants.
• Support daily operations with troubleshooting and maintenance support as required.
• Lead continuous improvement projects aimed at reducing waste, increasing productivity and strengthening compliance.

Confidential, Warminster, PA 

Engineering Manager 

Responsibilities:

• Managed a staff of 14 engineers located in two manufacturing facilities.
• Provided leadership and vision to a multidisciplinary engineering team that supports a $21M lyophilizer manufacturing business.
• Assign work to each member of the team based on project priority, individual workload and expertise.
• Monitored employee performance and held each engineer accountable for quality, cost and schedule on each project.
• Provide regular updates to customers, cross - functional stakeholders as well as upper management on the status of each project.
• Led continuous improvement projects aimed at reducing waste, increasing productivity and strengthening compliance.
• Recruited talented engineers and doubled the size of the engineering department in order to respond to recent growth.
• Reduced design defect to the manufacturing floor by 40% in less than one year in the role.

Confidential, Plainsboro NJ

Supervisor, Controls Engineering, Project/Team Leader - Corporate Facilities

Responsibilities:

• Managed the design, installation and validation of the Building Automation and Environmental Monitoring System for a 32,000 square-feet artificial skin manufacturing facility.
• Conceptually designed all controls and monitoring components for a PLC controlled building automation system.
• Designed and led the implementation of manufacturing IT subnet that supports the building automation system and other process and utility equipment.
• Performed cGMP/GAMP5 Risk-Based approach analysis to generate testing and Computer Systems Validation (CSV) strategy: (Functional Requirement Specification, Detailed Design Specification, 21CFR Part 11 Assessment, Traceability Analysis/Matrix, Factory Acceptance Testing, Site Acceptance Testing, Change Management, Configuration Management, Installation Qualification, Operational Qualification, Performance Qualification, Turn-Over Package Review, Go Live and User Training).
• Managed controls system vendor, programmers and testing staff.
• Led automation testing staff during system qualification and engineering lot manufacturing.
• Provided leadership for automation, instrumentation and IT support team of the newly built manufacturing facility.
• Assigned and supervised day to day tasks.
• Provided technical guidance and project management to the team.
• Wrote job description for new staff members.
• Wrote employee yearly goals.
• Conducted performance evaluation.
• Participated in performance differentiation meetings.
• Served as liaison between manufacturing and Corporate IT.
• Served as a member of the Extended Plant Leadership Team.

Confidential, Horsham PA 

Consultant 

Responsibilities:

• Worked with Confidential engineers to manufacture two sterilization ovens for a medical device customer.
• Developed code for confidential using DirectSoft5 software.
• Developed Modbus interface between Koyo PLC and Watlow EZ-Zone Controllers.
• Generated user manual, detailed design specification and system test protocol.
• Assisted with factory and site acceptance tests and startup.

Confidential, West Point PA

Senior Engineer

Responsibilities:

• Collaborated with business partners across different departments to investigate complex Atypical Process Reports (APR) for all Sterile Equipment Supply areas at the Merck West Point Vaccines Manufacturing Facility.
• Managed and completed Corrective Actions / Preventive Actions (CAPA) to address issues identified during atypical investigations or identified as potential future problems.
• Collaborated with operations and other supporting groups to achieve successful implementation of all CAPAs.

Confidential

Senior Automation Engineer 

Responsibilities:

• Supported the following Automation systems for confidential Vaccines Production.
• Production and Environmental Monitoring Delta-V DCS systems.
• Stand alone and integrated Allen Bradley PLC systems.
• PI Data Historian Systems.
• Performed System Life Cycle documentation reviews and provided test protocol execution support (IQ/OQ/PQ).
• Managed 21-CFR part 11 compliance projects for Pooling Sonication and Filtration system.
• Provided training and mentoring for new automation and IT support employees.

Confidential

Business Analyst

Responsibilities:

• Provided technical support for a large Equipment Tracking Database Project.
• Conducted interviews with end users and other stakeholders in order to understand and develop detailed and accurate system requirements.
• Developed standard operating procedures (SOP) and provided training for the new system.
• Worked with the end users to develop business cases and write capital requests for enhancement projects aimed at improving the system by adding new functionalities.

Confidential

Automation Engineer

Responsibilities:

• Support of the confidential
• Performed troubleshooting of PLC related issue.
• Supported maintenance and calibration activities.
• Made changes to PLC systems code.
• Managed and completed the confidential medium size IT Network Project).

Confidential, Trexlertown, PA 

Process Controls Engineer - Generated Gases and Services

• Designed control cabinets for small and large systems including cryogenic pumps, compressors, flow metering systems, ambient oxygen monitors and others.
• Wrote PLC programs for GE Fanuc and Modicon controllers.
• Specified control instruments including valves, transmitters, transducers, controllers, regulators, temperature and pressure switches and sensors, Confidential .
• Provided technical support to field engineers, technicians and customers during installation, start-up or maintenance of plants.
• Assisted in the DCS programming and the HMI configuration for a 500-ton per day air separation plant built in Hylsa, Mexico. This project came in significantly under budget.
• Additional Training & Professional Development

• Project Management, PMBOK Training
• Merck Lean Six Sigma Yellow Belt Certified
• Computer System Validation and Systems Life Cycle
• Fisher Rosemount Delta-V Basic, Regulatory Control and Batch Training
• Allen Bradley PLC
• Data Analytics
• Oracle, PL/SQL
• Minitab