Manufacturing Process Specialist

Orion Group Life Sciences are currently recruiting a Manufacturing Process Specialist on behalf of our Multinational Biopharmaceutical Client based in Cork on an initial 2 year contract with potential to extend.
 

• 5 days onsite initially for the first few weeks, transitioning to a hybrid model of 3 days onsite per week thereafter.

 
POSITION SUMMARY:

• Reporting to Manufacturing Readiness Manager, this position is responsible for completing material supply investigations and supporting first line troubleshooting of the day-to-day activities within Operations.

 
General Activities:

• Support material supply investigations to ensure supply chain maintenance.
• Oversee and manage global records raised by the Digital Operations and Technical Services (DOTS) team assigned to Cork site.
• Generate change control documentation to record changes to the manufacturing process, materials, sites, etc.
• Evaluate and strategize shelf-life extensions for single-use consumables, optimizing material usage
• Liaise with vendors and the wider members of the Cork Bio site to obtain relevant information for the completion of change controls.
• Investigating and resolving issues raised within the Manufacturing Department.
• Support Qualification activities for manufacturing single use consumables.
• Presenting to Change Control Board and raising of Change Controls for materials determined as suitable alternative for current materials.
• 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 behaviour in every activity.
• Carry out routine and non-routine tasks delegated by the Manufacturing Readiness 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.
• Prioritise 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 pertaining to single use material concerns.
• 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.
• Provide training and support to colleagues where required.
• Work closely with QA to maintain product integrity within extended shelf-life parameters.

 
LEADERSHIP RESPONSIBILITIES / INDIVIDUAL CONTRIBUTION

• Report to Manufacturing Readiness Manager.
• Represent the Material Supply Optimisation Team and/or 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 integrity.

 
ORGANISATIONAL INTERFACES:

• Interface at (Team Leader, Manager and Director level) with all site departments, Operations and Maintenance.
• Contact with Engineering, Quality, Logistics, Validation, Technical Operations, Training and other departments.
• Be conscious of internal customers to Manufacturing department and be cognisant of their requirements.

 
QUALIFICATIONS AND EXPERIENCE:
 
ESSENTIAL:

• A relevant third level qualification in either Microbiology, Biochemistry, Biotechnology, Science or Engineering.

 
DESIRABLE:

• Manufacturing experience within a GMP regulated environment.
• Project experience.
• Postgraduate Qualification.
• Experience of Microsoft Word, Excel and Outlook.
• Experience of SAP, electronic documentation system and/or other business systems.
• Lean/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
• Mechanical/Technical aptitude.
• Excellent communication skills both written and verbal.
• Attention to detail.
• Good problem-solving skills.
• Results and performance driven.
• Adaptable and flexible.

People are our business worldwide
 
Orion Group was founded in 1987 and is now one of the largest, independent, international recruitment companies. We have a network of 200 employees working from 24 offices, delivering a range of services – Talent Acquisition, Recruitment Outsourcing Services, Retained Search, Global Workforce Solutions, Completions & Commissioning and Materials Management – across 68 countries. As a global leader in workforce solutions, we recruit personnel across the Engineering & Technical, Office & Commercial, Scientific and Skilled Trades disciplines, for sectors including Oil & Gas, Life Science, Power & Utilities, Constructions & Infrastructure, Manufacturing and Renewables.