Manufacturing Process Specialist

Pe Global

Cork

PE Global is currently recruiting for a Manufacturing Process Specialist - Purification for a client site in Cork: Manufacturing Process Specialist. POSITION SUMMARY: Reporting to Operations Manager, this position is responsible for representation operations on capital project teams and supporting first line trouble-shooting of the day to day activities within Operations - These activities include but are not confined to: General Activities. • Represent Operations on cross functional project implementation teams. • Monitoring and troubleshooting of the manufacturing process and equipment issues and process optimization. • Monitoring and reporting of process performance using statistical process control. • Troubleshooting of DCS (e.g Delta V) and PLC control systems. • Investigating and resolving issues raised within the Manufacturing Department. • Participate in/ Lead Cross Functional teams when required. • Support of Commissioning and Qualification activities. • Preparation and updating of Batch Records, Procedures and Work Instructions. • Provide process and equipment related training as required within the Manufacturing Department. • Completion of assigned tasks to support manufacture of quality biomedicines in accordance with cGMP and EHS requirements. GENERAL SCOPE OF RESPONSIBILITIES: • Lead by example and strive to perform to high standards at all times. • Responsible and accountable for assuring the safe accomplishment of job activities, following good environmental practices and procedures. Commit to and demonstrate safe behavior in every activity. • Carry out routine and non-routine tasks delegated by the Operations Manager according to appropriate procedures, values and standards. • Carry out all activities in compliance with corporate and cGMP/EHS regulatory requirements. • Compliance with Manufacturing and general site procedures at all times. • Completion of all documentation in compliance with site procedures and GDP. • Execution of activities as necessary to meet operational and business needs. • Lead, support and participate in commissioning and qualification activities both current and future projects (and annual re-qualification activities). Also support to validation activities. • Prioritize and schedule activities to support business needs and to meet requirements of Master Production Schedule. • Lead and Support investigation and resolution of problems on plant. • Participate in and lead Cross-Functional teams as necessary. • Generate and assist with generation, review and revision of Manufacturing documentation as necessary. • Ensure that personal training requirements are completed in compliance with site procedures. Training and support for new recruits to the Manufacturing group. • Support ongoing studies by Validation, OTS and other support functions. LEADERSHIP RESPONSIBILITIES / INDIVIDUAL CONTRIBUTION. • Report to Operations Manager. • Represent Operations on cross functional project teams. • Be familiar with daily activities in Manufacturing. • Facilitate an environment of continuous improvement. • Facilitate an environment of open communication. • Lead investigations in work area as necessary. • Lead Cross-Functional teams as necessary to support site goals. • Support training of other Manufacturing colleagues. • Collaboration and teamwork. • Initiative and motivation. • Share ideas and suggestions for improvement and encourage others to do the same. Demonstrate Credo value of integrity. QUALIFICATIONS AND EXPERIENCE. ESSENTIAL. • A relevant third level qualification in either Microbiology, Biochemistry, Pharmacy, Biotechnology, Science or Engineering. DESIRABLE: • Manufacturing experience within a GMP regulated environment. • Experience of the cell culture or purification processes. • Project / New equipment installation experience. • Process engineering experience. • Commissioning and qualification experience. • Postgraduate Qualification. • Experience of Microsoft Word, Excel and Outlook. • Experience of DCS (e.g. Delta V), SCADA and PLC systems. • Experience of SAP, LIM’s and/or other business systems. • 6-Sigma/Kepner-Tregoe or similar problem solving/decision making methodology training. KEY COMPETENCIES REQUIRED: • Excellent interpersonal skills. • Ability to operate as part of a team is critical. • Customer focus. • Innovative. • Mechanical/Technical aptitude. • Excellent communication skills both written and verbal. • Attention to detail. • Good problem solving skills. • Results and performance driven. • Adaptable and flexible. Interested candidates should send their CV to Audrey.mccarthy@peglobal.net or call 0214297900. Although it is not possible for us to respond to all applications, we at PE Global will do our upmost to give you feedback on your application. You have sent your Cv into us as a company and even though you have sent your CV to a particular position, we are making the reasonable assumption that you are active on the job market and as part of our normal recruitment service we will discuss other suitable positions with you. You are free to opt out of this so please specify in your application to us if you just want to be contacted in relation to a specific vacancy. Your Cv is sent to a central recruitment inbox which a number of people in the applicable PE Global division have access to and so this means that you might not be contacted by the named person in this advert. This job originally appeared on RecruitIreland.com.

1916 days ago