Brian Still Email & Phone Number

Hutto, Texas, United States

Responsible for preparing written commissioning and qualification documents, validation protocols (IQ, OQ, PQ) including designing appropriate test plans. Perform the execution of validation protocols of an existing High Speed Vial Filling and Stoppering Machine. Added a new SCADA system that is (21 CFR part 11) compliant for electronic data, and records, etc. Performed technical reviews for the equipment, and documenting its process capabilities for production requirements.

King Of Prussia, Pa, Us

Providing direction to the Clean in Place (CIP) team; providing daily, weekly, bi-monthly scheduling. Providing hand-on electro-mechanical system troubleshooting; analyzing, and conducting investigations and provide direction to engineering and operations group proposing solutions to technical issues. Write specifications for equipment and instrumentation. Develop corrective actions as needed for anomalies observed during requalification of equipment.

Boston, Ma, Us

Hatboro, Pennsylvania, Us

Provided hands-on engineering management for commissioning, qualifications and start-up as well as making recommendations to the existing US Filter purified water system, Mueller WFI and Clean Steam systems. As well as the management and installation of a new Centrifuge, Fermenter, Autoclave, Waste treatment system, CIP system. Assigned to manage and provide decision making to equipment vendor ABEC, Turner Engineering for the SAT, Commissioning and Qualification. Completed hand-on field reviews of system (P&ID’s) Piping and Instrumentation Diagrams, and electrical diagrams field reviews, as well as other related drawings for SAT completion.

Andover, Massachusetts, Us

Provided hands-on engineering management assistance and recommendations to the Regenerons $50+ million dollar Ultra-filtration water system, clean utilities, and Bioreactor project as the Lead Commissioning and Qualification Engineer. Assigned to manage and provide decision making to equipment vendor MECO for the SAT, Commissioning and Qualification of multimedia filter, resin beds, softener, carbon bed filtration, ultrafiltration filters, two 20gpm WFI stills, two cross-tried 6000 gallon storage tanks, and a 3000lb/hr. clean steam generator; as well as managing the mechanical, electrical, and automation contractors. Assigned to manage the contractor for the WFI systems; Superior Equipment and Automation for the downstream multi-drop WFI Loops for HWFI, and AWFI water systems mechanical and automation and controls. Assigned to manage and providing decision making to equipment vendor ABEC for the SAT, Commissioning and Qualification of Commissioned new downstream 50L, 500L, 3000L, and two 10,000L bioreactors as well as a CIP system for biopharmaceutical processing. Completed hand-on field reviews of system (P&ID’s) Piping and Instrumentation Diagrams, and electrical diagrams field reviews, as well as other related drawings for SAT completion.Completed investigations of process equipment, utility systems, bioreactors, CIP system, and control system abnormities providing hands-on troubleshooting and repair. Assigned to supervise equipment vendors, mechanical, electrical, and automation contractors ensuring that the projects are completed as per systems designs to insure that the projects remain on schedule.

Andover, Massachusetts, Us

A team member of the Reliability Based Asset Management (RBAM) team; supporting the Durham NC vaccine manufacturing site equipment a reliability, and maintenance. Executed (RBAM) projects by completing assigned task that are considered good maintenance, and reliability practices for critical assets. Completed all documentation requirements ensuring tasks reside in the CMMS. Created preventive maintenance tasks for critical assets, created spare parts inventory for critical assets, created predictive maintenance tasks for critical assets, and complete life cycle evaluations for critical assets developing technical documents in support of equipment reliability, and maintenance. Providing weekly project metrics that include schedule details, budget details, open action items, accomplishments, issues and critical milestones.

Lake Forest, Il, Us

Responsibilities include establishing an industry complaint instrument calibration program through the management SOP’s, industry standards, using measurement standards that are calibrated using NIST traceable instruments. Ensure that all instruments meet operational specifications that are properly calibrated, maintained, and documented for regulatory reviews. Ensures all departmental procedures meet corporate requirements, and industry standards. Other responsibilities include managing the Automated Process Control Systems (APCS); responsible for ensuring that the APCS’s are appropriate for the desired task and meet Site and Corporate procedure requirements. Responsible for the implementation of new APCS applications and changes to facilitate compliance, cost, quality, efficiency and material loss improvements. Responsible for establishing and maintains programming, security, configuration and software retention standards for APCSs and configurable devices.

Provide maintenance, and engineering technical support to production maintenance teams, maintenance engineers for manufacturing equipment and facilities. Supporting projects various Contractor services and vendors for mechanical, electrical, instrumentation, process control (DCS, PLC’s). Assist in project engineering design, installation, P&ID review, instrumentation, electrical, and loop drawings review, site acceptance testing, validation, start-up, and commissioning.

Project engineering support for the process automation, instrumentation and engineering functions which includes; managing the close-out, and start-up of instrument calibrations for a new software up-date, managed new instrument installations, full loop testing from field device to PLC/HMI, start-up, validation, and Commissioning of batch, and continuous manufacturing processes, WFI, CIP, new utility and existing systems and equipment.

Atlanta, Ga, Us

Provide technical day-to-day hands-on leadership directing, controlling, and coordinating all phases of the Maintenance Department. Maintaining the production plant, warehouse and office facilities, and all equipment used to produce quality products in an efficient and profitable manner. Provide leadership to two supervisors, 17 maintenance technicians, two (2) parts/storeroom clerks, and one planner/scheduler.

East Windsor, New Jersey, Us

Investigated major and minor investigations; developing reports of atypical events requiring root cause identification, and corrective/preventative action (CAPA) for process vaccine equipment processing in multiple unit operations, including fermentation, chromatography, and TFF. Specifically; investigations were of temperature, flow, weight, pressure devices, and automation that are found to be out of tolerance (OOT), as well all mechanical processing equipment.

Paris, France, Fr

Provide technical day-to-day hands-on leadership, mentoring, training, and supervising the production and facilities maintenance and prevent maintenance teams comprised of 2 maintenance managers, 3 maintenance supervisors, 25+technicians and maintenance engineer that maintains, troubleshoot and repair to industrial vaccine, filling and packaging production equipment for a 24/7 operation. Prioritizing department goals, performance reviews, administering company practices, policies, procedures, and strategies. Manage maintenance and compliance programs; contractor services contracts, and vendors. Prioritize and organize critical maintenance management activities supporting the production of vaccines; with-in cGMP, sterile and aseptic processing facilities. Manage energy and conservation, and continuous production and maintenance improvements. Planned and managed maintenance budget; manage engineering projects, renovations, installations, validation, HVAC / refrigeration, BMS, PLC, instrumentation, metrology, controls, non-critical and critical utilities (WFI, RO, DI, and clean steam).

Sr. Superintendent (Mid Manager Level) Site Utilities Automation, Controls and Instrumentation (5/1995-10/2005)Provide technical leadership, mentoring and supervision to the I&C department with staff of 3 engineers, 2 supervisors, and 25+ union technicians ensuring that all instruments and systems are installed, and maintained in compliance with regulatory, quality, and safety. Served as project leader managing electro-mechanical projects, DCS and PLC control systems, instrumentation, stream systems, compressed air systems, RO and DI water systems, site potable water systems, (BMS) building management systems, boilers, and turbine generators. Assume responsibility for Change Control and Configuration Management after system acceptance.Additional experience includes roles as Senior Automation, Controls and Instrumentation Engineer, Supervisor of I & C Maintenance and Site Engineer of Maintenance

Ms, Engineering Management

Bs, Electrical Engineering

Associate’S Degree, Electrical And Electronics Engineering

Diploma, Heating, Air Conditioning, Ventilation And Refrigeration Maintenance Technology/Technician