Patrick Kelly - Manufacturing Associate III at Alkermes

Manufacturing Associate III at Alkermes

Nationality

Irish

Work category

Pharmaceutical and Science

Education

Bachelor/Degree

Profile Activity

Profile:
A fast learner, always looking for creative ways to improve the process. A clear communicator, with an ability to relay complex process information in a straight-forward manner. Skilled at working across departments to develop effective processes and to deliver projects. Achieves targets and results with high integrity.

Patrick Kelly's Professional Experience

2008 - 2012

Cordis - Manufacturing Team Member

•Working in clean room environment as Manufacturing Team Member.
•Moved within the J&J Cashel Campus from Alza to Cordis recruited within J&J to Move to Menalo Park in California to train in Conor Medsystems for a period of 4 weeks on NEVO™ Sirolimus-eluting Coronary Stent.
•Trained Manufacturing Team Member’s in Cordis Ireland and became an SMT (Subject Matter Trainer)
•Worked very closely with every department within Cordis including Process Engineers, PET Team, Planning,Techs,IT, Supervisor’s and Management.
•Was sent to Menalo Park for a Further 2 weeks for in depth training on the P3 Filler Jets. After this 2 weeks and further learning of the Filler Machines and Jets I became a SME (Subject Matter Expert in Filling) and part took in Train the Trainer course.
•Day to Day activities included setting up Filler Machines, Logbooks, Using MES system and JDE, CPDM Compliance wire, Updating Day by the Hour metrics and OEE Yields.
•Very experienced in both Internal and External Audits including FDA, BSI, IMB and Anvisa.
•I have assisted in the creation and maintenance of up-to-date area SOPs and batch production records.

•Responsible for completing daily cGMP operations according to SOPs and batch record instruction in a cGMP environment.
•Perform all phases of cGMP production, including maintaining a cGMP environment, inspection, packaging, sterilization, material handling and process troubleshooting during commissioning, start-up, development, validation, and cGMP production.
•Carry out all production duties whilst strictly adhering to pre-defined procedures.

Key Skills
audits engineers FDA IMB JDE SMT Supervisor Trainer Validation
2006 - 2008

Alza Corporation - Manufacturing Team Member

•Join Alza in Nov ’06 where I worked as a Manufacturing Team Member
•Responsible for completing daily cGMP operations according to SOPs and batch record instruction in a cGMP environment.
•Perform all phases of cGMP production, including maintaining a cGMP environment, inspection, packaging, material handling and process troubleshooting.
•Carry out all production duties whilst strictly adhering to pre-defined procedures.
•Participate on equipment & process start up teams.
•Set up, adjust, operate, maintain, perform first line maintenance tasks and clean complex machines to perform Drug/device manufacture & assembly.
•Perform equipment and facility cleans as & when required.
•Provided suggestions for improvement in operating time, yields, ergonomics, handling, line organization, etc.
•Record daily outputs and provide a detailed handover to the incoming shift.

2002 - 2006

Guidant Ireland Nov 2002- May 2006 - Manufacturing Team Member

•Working in clean room environment as general operative for Guidant Ireland Limited, Clonmel as part of a manufacturing team.
•As part of a team I was responsible for meeting targets and reaching goals in the production area.
•My role was testing the pacemaker on E2 Machines.
•I also wet blasted each unit until there was an even finish on each can and no imperfections.
•I also inspected each unit in an x – ray machine. I followed each step as per my GMAI.

Key Skills
STEP

Patrick Kelly's Education and Qualifications

2011

Bachelor/Degree - diploma, Web Design

HSI Limerick Business School

Bachelor/Degree - Cert, Completed ECDL and Office Skills

Clonmel Training Enterprise

Patrick Kelly's Additional Information