Experience

MSD Ireland

• Ireland
• Pharmaceutical Manufacturing
• 300 - 400 Employee

• Sr. Automation Specialist

  • Aug 2023 - Present

  OEM lead responsible for process automation equipment across operational areas of Vaccine at new Rathgall Facility.

• Automation Specialist

  • Dec 2017 - Aug 2023

  OEM lead responsible for process automation equipment across operational areas of Vaccine, Sterile and Pharmaceutical Operations. SME lead for participation in both corporate and regulatory Audits (HPRA, FDA) for key OEM production equipment. Project Automation lead on software/hardware upgrades across multiple changes that involved cross functional support and Co-ordination to improve stability, robustness and increase efficiency. Key participator in the Tier process and proactively resolved technical issues before impacting the business. Supported the smooth running of the site value stream and responsible for process improvement on Vial Filling lines. Took ownership of ERMD projects and provided technical expertise in helping key milestones were successfully met. Proficient in QMS investigation systems, including deviation incidents and CAPAs using SAP platform through initiation to closure. Oversaw investigations of automation anomalies to prevent recurrence.Mentored and encouraged junior members of the team by facilitating workshop demonstrations and sharing knowledge of best working site practices.Actively ensured that legacy processes were improved and supported automation department to modernize and align with new site processes.Site technical lead for new QO lab in 2018/2019 that provided guidance and knowledge to ensure technical, compliance and data integrity requirements for introduction of 25+ systems and successfully supported Regulatory and Data Integrity audits on same systems with no observations.SAP and change control (Trackwise / IPI) SME for OEM department. Show less



Milestone Solutions

• Pakistan
• Advertising Services
• 1 - 100 Employee

• Automation Compliance

  • Jun 2017 - Dec 2017

  • Responsible for reviewing core site Automation Compliance aspects of cGMP for operational areas of Vaccine Sterile and Pharmaceutical Operations.• Area of operations include site facilities, utilities, manufacturing and laboratories.• Supported and performed core activities associated with Automation that include Qualification of Automation Systems, System Life Cycle Management and Compliance Oversight. • Responsible for compliance review, assessments, and conformance to Manufacturing Standards, MMD Quality Policies/Guidance for Automation System Development Life Cycle, and site procedures in accordance with regulatory regulations as related to the qualification, maintenance, auditing, and retirement of automated systems.• Provided guidance and technical skill knowledge to site relating to automation SDLC and computer validation concepts.Provided quality assurance and oversight on re-introduction of Automation equipment to production and verify adherence to site and global procedures. Show less

• Automation Engineer

  • Jun 2015 - Jun 2017

  • Provide Automation support and expertise to assist the manufacturing division to manufacture quality pharmaceutical products to meet Compliance, Supply, Strategy and Profit Plan. • Responsible for implementing Site Change Controls to Process Automated Systems, driving Risk Assessments and streamlining Preventative Maintenance Plans. • Commissioning Automation systems to adhere to business requirements in accordance with site validation plan.• Responsible for liaising with Vendors to ensure that Software upgrades performed to automated systems on-site meet the system requirements along with ensuring that all documentation comply with on-site change control procedures.• Required to comply with Company Policies, Procedures and Guidelines, regulatory requirements and execute current Good Manufacturing Practices (cGMP) in the performance of day-to-day activities and all applicable job functions.• Coordinating and prioritizing work tasks based on deadlines, acute awareness to adapt to deadline dates that might differ with little notice.• Completing scheduled Preventative Maintenance Work Orders on both OEM and laboratory systems to pre-defined deadlines.• Responsible for fully re-instating OEM systems to their qualified state in the event of a Disaster occurring on a locally administered system.• Responsible for administering recipe changes to OEM systems and executing protocols to validate systems along with updating system deliverables as a result of the change. • Taking part in Risk Assessments to ensure technical aspects are identified and evaluated, including risks identified because of the system configuration, hardware, and data Integrity.• Well versed in 21 CFR part 11 and industry regulation standards. Show less



Benning Power Electronics

• Switzerland
• Electrical Equipment Manufacturing
• 1 - 100 Employee

• Electronic Engineer

  • 2011 - Jun 2015

  • Lead role in the design and implementation of the software architecture for an in-house custom automated production line. • The scope of project comprised of the software development using graphical programming platform LabVIEW, Integration, data acquisition and communication with PLC, Vision recognition system, Robotics and MS Access database integration to interpret and analyse the data generated throughout the inspection process. • Responsible for diagnosing, testing, calibrating and repairing electronic test equipment. • Devising and preparing electrical and functional test documents and work procedures for various departments including Assembly, Component Preparation, In-Circuit Test and Modules. • Analyzing and interpreting weekly trends in production output, including machine down-time, yield and reject rates for optimizing production in accordance to the lean manufacturing 6s program. • Implemented strategies for continuous improvement by maximizing the performance of each process and developed strategies to align the tact time of each process to increase overall efficiency and yield of process/product. Show less