Major Activities

• Effectively working within a multidisciplinary team to Prepare, schedule and execute Commissioning, Qualification and Validation protocols.
• Lead Risk assessments for process and equipment as required.
• Develop system impact assessments, validation plans, protocols and reports that support the qualification and validation of systems.
• Execute Commissioning and validation of manufacturing equipment, downstream equipment and processes in addition to supervising and witnessing Validation / Qualification carried out by vendors.
• Develop protocols for validation projects using a risk based approach that meets regulatory requirements and industry practices.
• Review and approve Layout development and review for material and personnel flow compliance.
• Review analyze and interpret system performance data for completed validation and prepare final report packages by summarizing the data.
• Investigate deviations, write investigation reports and create summary reports.
• Manage equipment vendors to get vendor qualifications scheduled and executed.
• Promote cGMP and regulatory compliance into assigned projects.
• Exercise good judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions.
• Strong trouble shooting and Safety compliance experience is essential for this role.
• Responsible for ensuring that own work complies with GMP, Data Integrity and Good Documentation Practice (GDP) and is undertaken in accordance with applicable procedures.
• Responsible for ensuring that own training is undertaken in a timely and GMP compliant manner before the task is undertaken.
• Responsible for ensuring that any GMP documentation assigned to me e.g. (but not limited to) Issues, CAPAs, Change Controls, BMRs & audit/inspection actions are closed timely and in a RFT state.

• Comprehensive practical and theoretical understanding of a wide range of industrial plant and cleanroom services and utility equipment.
• Proven experience in commissioning plant and equipment in a GMP environment
• Problem Solving - Identifies and resolves problems in a timely manner; gathers and analyses information skillfully; develops alternative solutions; works well in group problem solving situations; uses reason even when dealing with emotional topics.
• Leadership - exhibits confidence in self and others; inspires and motivates others to perform well; effectively influences actions and opinions of others; accepts feedback from others; gives appropriate recognition to others.
• Motivation - sets and achieves challenging goals; demonstrates persistence and overcomes obstacles; measures self against standard of excellence; 
• Planning/Organizing - prioritizes and plans work activities; uses time efficiently; plans for additional resources; sets goals and objectives; organizes or schedules other people and their tasks; develops realistic action plans.
• Professionalism - approaches others in a tactful manner; reacts well under pressure; treats others with respect and consideration regardless of their status or position; accepts responsibility for own actions; follows through on commitments.
• Quality Management - looks for ways to improve and promote quality; demonstrates accuracy and thoroughness.
• Innovation - displays original thinking and creativity; meets challenges with resourcefulness; generates suggestions for improving work; develops innovative approaches and ideas.
• Communication - verbally communicates clearly and persuasively; listens and seeks clarification when needed; good presentation skills; participates effectively in meetings. Writes clearly and informatively; varies writing style to meet needs; presents numerical data effectively; able to read and decipher written information.

Experience / Professional Background

• BSc/MSc or BEng/MEng in Engineering or related discipline.
• 5 -7  years minimum in validation, quality systems, operations, engineering or any combination thereof.
• Experience in multiple GMP validation disciplines (process equipment, utility, automation, computer systems, sterilization) with advanced technical knowledge.
• Validation experience using risk based approach guidelines, international regulatory requirements and standards and other in.
• Experience interacting with or creating material for representatives of regulatory agencies and executive level staff.
• Experience with investigations into manufacturing deviations and determination of product impact potential, root cause and corrective actions.