1. Colin Maher.
Personal details:
Address: 6 Clevedon Gardens, Upper Kilmoney Road, Carrigaline, Co. Cork.
Tel :(00353) 0861029799.
Email address:colinmaher81@yahoo.co.uk
Profile:
Talented professional with over 23 years Process Operation, Instrumentation / Electrical and
Mechanical experience in the Pharmaceutical, Biopharma, Manufacturing and Construction
industries.
Successfully completed (2011) Fas training course in Biopharmaceutical / pharmaceutical
operations FETAC level 5 major award. (Achieved highest grades available and excellent
feedback from instructors).
Currently working as a Biotechnician for the past 2 years in a HPRA/FDA regulated biotech
facility, gained 3 years’ experience working as a Process operator in a HPRA/FDA regulated
bulk pharmaceutical manufacturing facility, 4 years maintenance experience in a HPRA/FDA
regulated bulk API facility and 14 years working in construction as an Instrument
technician/supervisor on a number of large projects and training.
Highly motivated, multi-skilled professional, who is enthusiastic and reliable, and will operate
very efficiently as a sole contributor, team player or in a lead role and achieve results.
Career history:
Employer: Biomarin date: 4 Feb 2015 to present
Position: Biotechnician. Working with the Support Services team on 3 shift rotation and 8
months previously with Downstream.
Duties and responsibilities:
 Responsible for Media and Buffer Batch manufacturing and training of other team members in all
aspects of production, best practice and troubleshooting
 Operation of Parts Washer and Autoclave involving coordination of upstream, downstream and
QC load schedule
 Training biotechnicians as SME for Media and Buffer prep, Filter integrity testing, Osmolality
testing, Sealers and Welders
 Successfully trained as ORACLE MES supervisor, responsible for release,review and approval
of electronic batch records
 Key contributor in Downstream operations during Commissioning and Qualification of
equipment
 Successfully completed NIBRT Downstream 2 week training course and achieved highest results
available in final exam

2.  Select and trained as SME for Freeze/Thaw skid and Bulk Drug Substance Filling Station and
was responsible during commissioning for delivery of both systems start up on time.
 Selected and trained as Media preparation representative for HPRA audit
 Proficient in Trackwise, LIMS, CMMS, Safepermit, SIMS incident safety management system
 Selected for and trained as Site First aider (Fetac qualification)
Employer: Novartis Ringaskiddy. Dates: 1st April 2012 to 4 Jan 2015.
Position: Process operator. Working as part of an 8 man team on 4 shift rotation.
Duties and responsibilities:
 Charging bulk raw materials in FIBC’s to vessels via PTS and glove box.
 Controlling many different processes using recipe driven DSC. (Baily).
 Operating transfers of batches in a safe and controlled manner.
 Taking samples and communicating results using SAP.
 Completing electronic and written batch records using Cgdp.
 Milling product, unloading in cleanroom and transferring to warehouse using forklift.
 Cleaning and sanitising cleanrooms.
 Disposing/managing waste using 5S waste tracking system.
 Isolations and weekly filter changes and checks.
 Logging safety and quality walk down reports.
 CIP of dryers, reactors,filters and mill.
Employer: Pfizer Ringaskiddy, kilo Technology Laboratory. Dates:24th January to 1st April
2011.
Address: Ringaskiddy, Cork.
(Brief description of business) Pfizer KTL produces small volumes of Active pharmaceutical
ingredients for research and development, clinical trials and scale-up of processes.
Position: Process operator.
Duties and responsibilities:
 Assembly and Set- up of mobile equipment for processes.
 Dispensing and staging raw materials as required in the batch record sheet using hand/pneumatic
and electrical pumps, weigh balances and various graduated cylinders.
 Charging raw materials into mobile vessels under vacuum and inerting vessels before transfer.
 Reactor operation using DCS. (Delta v)
 Centrifuge dryer operation.
 Ph calibrations and Weigh platform calibrations.
 Sampling process steps,labelling and shipping to lab.
 Operating vacuum dryer.
 Cleaning of process equipment as per cleaning record sheet.

3.  Creating and amending quality control documents. (New sop for distribution of de-ionised water
drums.)
 5S and Continuous improvement project work involving process equipment identification and
location to reduce down time during process changes.
 Waste management. Including, drumming off waste from IBC’s,pumping out bunds, collection
and storage of drums.
Employer: Dornan Engineering. Dates: Apr 2010 - Sep 2010
Address: East Gate Avenue, Little Island, Cork.
(Brief description of business)
Dornan Engineering is a large electrical, instrumentation and mechanical contractor with project
work in Ireland and overseas.
Position: testing technician. (Based in Frankfurt Germany working for quality assurance
department)
Employer: Corden PharmaChem Dates: 2006 to 2010
Address: Little Island, Cork.
(Brief description of business)
Bulk API manufacturing facility employing 100 people. (Ceased operation 2010).
Position: E&I Maintenance Technician.
Primary responsibilities:
 Supporting production by carrying out Preventative/Routine maintenance routines and
breakdown work of plant Electro/ mechanical, pneumatic and hydraulic Equipment,
instrumentation and Utilities, e.g. reactors, dryers, filters, PLCs, HVAC, weighing
equipment, plant air and nitrogen supply, heating and cooling systems, de-ionized water
system, wwtp, power and lighting, fire alarm.
 Calibration of wide range of process instruments including, Temperature, Pressure,
Flow, Level, Conductivity, Ph, Weighing scales. Also Environmental monitoring
equipment including TOC, THC, HCL, O2, LEL meters and laboratory equipment.
 Planning the calibration schedule, developing SOPs and training contract personnel in
related SOPs.
 Managing PMs, calibration results, deviations and change controls in a regulatory
manner. (Electronically In Pemac and Trackwise. Also written calibration certs)
 Continuous Improvement project work including specification, purchase, commissioning
and validation of new instruments.
 Deputising for the E&I supervisor in his absence.
Achievements:
 Assumed early responsibility for responding to equipment break-downs and process
issues that could arise daily or during unsocial hours.
 Revision of the company Calibration schedule resulting in reduced contractor support.
(10 weeks to 4).
 Led a successful safety automation project involving high level interlocks on solvent

4. storage vessels (12) in tank farm and successfully handed over project on time.
 Was a key contributor to a DCS system upgrade leading and carrying out Loop checking,
IQ, OQ, PQ. Project delivered on time despite challenging time-frame.
Employer: Suir Engineering. Dates: 2005-2006
(Brief description of business)
Process mechanical, electrical and instrumentation contractors.
Position: Instrument technician. (Based in Jansen pharmaceutical P3 project working with
commissioning/ start-up team for 6 months)
Employer: IIF electrical. Dates: 1999-2005.
(Brief description of business):
Process mechanical, electrical and instrumentation contractors.
Position: Instrumentation charge-hand.(Based primarily in Pfizer loughbeg)
Achievements:
 Promoted from technician to charge-hand.
Other employment: Dates: 1992-99
Employers:
 C.G. services, Manning Electrical, Dumul Elec/inst, on hire from IIF to Pfizer for 11
months, on hire from IIF to Buckeye for 10 months.
Positions held:
 Instrument technician.
 Electrician.
 Apprentice.
Employment locations:
GlaxoSmithKline, Novartis, Pfizer loughbeg, Buckeye, Irish Steel, Whitegate Oil Refinery,
Schering Plough Brinny, Emc, ADM, Sydney Australia, Maastricht Holland, Rotterdam
Holland, Ticona Project Frankfurt, Germany.
Education:
Third level: Instrumentation Apprenticeship, City & Guilds 225, National trade Certificate.
City & Guilds 275 Technician exams Pts 1,2&3 (Evening Classes).
Institutions: Fas Cork, CIT, Carlow RTC.
Dates: 1991-95.
Second level: Colaiste Chriost Ri.Cork (leaving certificate).
Additional training/certificates:
 Pharmaceutical/Biopharma operations accredited at FETAC level 5. Sep 2010 –Jan
2011. Modules include: health & safety, quality & cGMP, documentation, SOPs, dispensing,
utility systems, computerised systems, cleaning and sanitization, cleanrooms, bioreactor
operations, downstream processing, sterile product preparation.
 Certificate in Process plant operations. City & Guilds 601-057. (Distance learning

5. course).
 NIBRT downstream processing 2 week training course
 Foxboro Invensys. Configuration essentials DCS operation and programming.
 Experience of Microsoft Word, Excel, PowerPoint, Outlook.
 Mewp & boom hoist operation.
 Confined space entry.
 Manual handling and lifting.
 cGMP & GDP
 Counterbalance forklift and stacker certification.
 Train the trainer certification.
 SAP, WERUM ebr, trackwise.
Interests&hobbies:
I enjoy Tag Rugby, DIY, 6 a side Football, Golf and Watersports.
I am currently a member of Monkstown Golf Club. Cork.
References:
Available on request.