Engineer Process
Resume:
CURRICULUM VITAE.
Personal Details:
NAME : Mr. Alan Mullins.
DATE OF BIRTH : 21/01/75.
NATIONALITY : Irish.
ADDRESS : ** *** ***** *****, *********** Road, Naas, Co. Kildare.
CONTACT DETAILS: +353-**-***-**** (mobile).
E-mail: *****************@**********.***
Qualifications:
Bachelor of Engineering: Mechanical, University of Limerick, Ireland. (1992-1996)
Major Option in Fluid Mechanics.
Final Year Project titled: ‘Design, construction, and testing of a plate mounted shear stress measuring device’.
Experience:
Merck Sharp & Dohme, Carlow, Ireland. (Manufacturers of sterile injectables) (June 2009 - Present)
Title: Process Engineer
Activities:
● Responsible for the design and installation of Baush & Strobel syringe handling equipment (denesting, labelling and renesting machines). FAT coordination and close-out, equipment installation.
● Vendor selection, front-end design, URS generation and purchase of automatic glove testing machine for filling isolator.
Injectalia S.R.L, Pomezia, Italy. (Contract manufactures of sterile injectables)
(November 2007- June 2009)
Title: Qualification Lead.
Activities:
● Responsible for equipment and clean utilities qualification of new vial filling department. Aseptic filling process.
● Responsible for equipment and clean utilities qualification for new pre-filled syringe production department: Following qualification program the department received FDA and Italian Ministry approval.
● Qualification of GF automatic visual inspection machine. Vision tuning, operator Knapp test, selection and qualification of defect samples. Parameter and recipe management for 3 different products.
● The following systems are installed in the new pre-filled syringe department: Utilities (HVAC, WFI, Clean Steam), Process Equipment (autoclave, formulation vessels, Groninger RABS syringe filling machine) and Packaging (plunger insertion, labelling and blistering machines).
Patheon Italia S.p.A, Ferentino, Italy. (Contract manufacturers of sterile injectables)
(March 2007-October 2007)
Title: Business Manager.
Activities:
● Managed numerous international clients, overseeing each manufacturing contract.
● Responsible for coordinating all commercial and technical activities relating to the client, required to support drug validation through to drug manufacture. Largest contract provided revenues in excess of 12 million euro.
● Managed transfer of an established production process to a second manufacturing facility: Cost definition, project schedule, agreed validation strategy.
● Issued pricing and manufacturing contract proposals for potential new business.
● Appointed a ‘Facilitator’ during successful 5-day FDA audit of manufacturing facility.
LEO Pharma Dublin, Ireland. (Manufacturer of pharmaceutical gels and ointments)
(April 2005-March 2007)
Title: Process Engineer
Activities:
● New aseptic manufacturing line: Responsible for design, installation and qualification of bulk-processing step, up to product fill. Fully automated batch manufacturing process. Successfully delivered project ready for IMB inspection.
● Responsible for ‘scale-up’ of existing manufacturing process: Equipment modification and qualification.
● Developed and successfully implemented corporate commissioning and qualification procedures in line with ISPE Guidlines.
Wyeth Bio-Pharmaceuticals, Dublin, Ireland. (March 2003-December 2004)
Title: Commissioning / Validation Engineer
Activities: Responsibility for FAT close-out, SAT execution, IOQ execution. Assigned to the following systems:
● Two autoclaves, parts washer: Drug Product Area.
● HVAC system, process gas systems, ‘black’ utilities: Pilot Lab area.
Pfizer Bulk Chemical Site, Loughbeg, Co. Cork, Ireland. (December 2000-September 2002)
Title: Maintenance Engineer.
Major Projects:
● Provide technical support for scheduled and unscheduled maintenance on process equipment:
● Responsible for all site service contracts.
● Co-ordinated annual shutdown maintenance work.
● System upgrade of all containment booths according to cGMP standards.
● Introduced and managed a pump seal software program to track seal failures and assist in seal selection.
E.G. Pettit & Co. Consulting Engineers, Cork, Ireland. (March 1998 – November 2000)
Titles: Design Engineer
Major Projects:
• Mechanical Design (selection of process equipment) for a start-up food company.
• Building Services Design (HVAC and utilities) on medium budget construction projects
• HVAC Cleanroom Design for Schering Plough project (class 100 and class 10,000 specification).
• Responsible for purchase of an hydraulic waste compaction machine. Prepared operational design specification.
• ‘On-site’ project engineer for dairy production company.
Boeing Group, Seattle, Washington, USA. (April 1994 – December 1994).
Title: Student Engineer (9 month internship during 2nd year in college).
Major Projects:
● Compiled data on passenger seat flammability, to aid flight certification of new seat designs.
● Reviewed and decided on proposed changes to a standard operating procedure relating to seat installation.
Languages:
Italian. Excellent level.
French. Leaving Certificate Honours level.
References:
Available on request
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