Process Equipment Engineer

JOB TITLE

Process Equipment Engineer - 11+ Months

THE COMPANY

One of the top Pharmaceutical Companies in the world. The organisation is seeking a talented indivdual to join them. This is an excellent opportunity for someone looking to progress their career in Pharmaceuticals working within a global company.

LOCATION

Dublin&Cork, Ireland

SALARY
€40-€70 Per Hour

DESCRIPTION

The Process Equipment Engineer will report to the Equipment Technology Lead and should have the ability to:

• Ensure all equipment installed is safe, effective and in compliance with industry standards.
• Ensure all company and site engineering policies and procedures are adhered to.
• Provide technical and compliance review of testing protocols and reports.
• Lead or support major equipment related investigations and implement equipment CAPA and performance improvements.
• Generate and execute documentation for cGMP validation, requalification and periodic review of systems, equipment & manufacturing processes, including validation plans, annual revalidation plans, risk assessments, IQ/OQ/PQ/QV protocols and reports to maintain the equipment in a validated state.
• Write structured Engineering memo's in support of investigation closures.
• Provide routine equipment technical support and troubleshooting for resolution of manufacturing issues.
• Provide technical training on process and equipment as required by Operations.
• Develop and maintain productive links with process equipment & technology suppliers and vendors.
• Support Compliance Inspections and enquiries from Regulatory Agencies.
• Provide technical expertise during audits and also to present/ defend engineering systems, applicable change controls, investigations and equipment requalification packages to the regulatory agencies as required.
• process improvement projects that support the 4 Pfizer strategic imperatives of Cost, Quality, Customer & Buffer.

REQUIREMENTS

• Minimum qualification of a Degree in Engineering or Science with particular emphasis on Process, Chemical and Mechanical disciplines.
• Minimum of three years relevant experience in Engineering, Technical or Operations.
• DeltaV or similar systems

• Experience working in an Engineering or Technical discipline with exposure to one or more of the following (Drug Product Aseptic processing / Bulk Drug Substance manufacture / Vaccine Conjugation / Small molecule API / Medical Devices)
• GMP industrial experience in a regulated environment.
• Understanding of Pharma / Bio-pharma process equipment including: Process Vessels, Chromatography, Ultrafiltration, Autoclaves, CIP systems, Parts washers, and Clean Utilities.
• understanding. Proficient in the use of structured problem solving tools such as Process Mapping, RCA (Root cause analysis), FMEA's (Failure Mode effects analysis) etc.
• Excellent communication and interpersonal skills and an ability to work independently
• QTS training for events, commitments and change controls.

ABOUT i-PHARM CONSULTING

i-Pharm Consulting is a specialist Recruitment Company servicing the Pharmaceutical industry in the UK and Europe. We provide both permanent and contract staff to a wide range of Pharmaceutical, Medical Device, Biotechnology and Contract Research Organisations (CROs). i-Pharm has specific expertise in Clinical Research, Medical Affairs, Regulatory Affairs, Pharmacovigilance, Quality Assurance and Bioinformatics.

www.i-pharmconsulting.com

TO APPLY:
If you would like to discuss this vacancy further, please call the Global Strategic Delivery Consultant Billy Twomey on +44 (0)20 3189 0460. If this role is not suitable, Billyis also available to discuss other possible positions or answer any general questions regarding your career and the current market.

KEY WORDS
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