Commissioning & Qualification (C&Q) Engineer

This position will report directly to the Site Engineering Lead, and together will serve as partners alongside other stakeholders to ensure compliance and execution of site Commissioning & Qualification activities. 

The consultant will have responsibility to ensure that site C&Q activities comply with industry regulations for the commissioning and qualification of manufacturing equipment and systems, utilities and facilities. 

The site needs support in CQV as they plan to set up a new production line, and the consultant will be the CQV project lead, dedicated to this line.

Responsibilities

Key objectives of this position include:

1. Support the preparation and development and ultimately approval of the Site Validation Master Plans in key areas including Facilities, Equipment, Utilities and computerized Systems.
2. Provide technical support to Global Manufacturing Technology (GMT) teams to ensure that activities associated with the recommissioning of the Rathdrum facility and transfer of new products are in compliance with regulatory, corporate and site procedures and reviewing and approving transfer protocols, summary reports, strategy documents, qualification documentation, change control related documentation to support new product introduction.
3. Own, lead and monitor execution of site C&Q activities and be responsible for the site C&Q system governance through management review to ensure its continuing suitability and effectiveness, notifying any predicted shortfall or discrepancies against timescale and budgets,
4. Be site Subject Matter Expert (SME) for C&Q activities, reviewing and approval of all C&Q related plans, protocols and reports. 
5. Through Key Quality Performance Indicator Dashboard, monitor C&Q activities to ensure they consistently remain in place, in use and in control, comply with Corporate Global Quality Policies and Standards and meet the most current regulatory requirements and best industry practices,
6. Monitor Internal and External Factors Impacting C&Q System (i.e. emerging regulations, innovations that might enhance the pharmaceutical quality system), to ensure compliance with the change regulatory environment
7. Assure the use of operational excellences tools in quality procedures and processes,
8. Immediate notification to the Site Engineering Lead of any equipment or system deficiencies that could impact the qualification status of the equipment or system, and provide accurate and relevant information as required by the business,
9. Drive continuous improvement initiatives which positively impact cycle time, productivity, efficiency and quality of work through Lean methodology,
10. Active participation in site Tier meetings
11. Comply with the relevant Safety Statutory provisions, and in particular must take reasonable care for their own safety and that of others who may be affected by their acts or omissions at work.  All employees must comply with the site’s safety rules and instructions, and must report all accidents, injuries, defects or situations which they believe could present a hazard to themselves or others.
12. Required to safeguard company assets and ensure that all resources are expended or consumed in a prudent manner.
13. Ensuring that they perform their role to a high standard and deliver on objectives/duties assigned to them.

Requirements

• Undergraduate degree in pharmaceutical, Engineering, biological or chemical sciences.
• Relevant advanced degree preferred.
• 8+ years relevant experience in Pharmaceutical and/or Animal Health industry, with a significant experience in C&Q activities.
• Current knowledge of cGMP’s and regulatory guidance required with emphasis on all elements of C&Q e.g. equipment, process, analytical and computer C&Q.
• ICHQ7 Manufacturing Site experience preferred.
• Recognised LSS Qualification (Yellow belt, Green Belt, Black Belt) desirable.
• Demonstrated knowledge and success in C&Q of manufacturing facilities, systems and equipment.
• Ability to develop and adhere to self-directed standard work-organized and methodical with minimal guidance and be comfortable working as an individual and part of a team.
• Exercises Good Judgment and Drives Change for Competitive Advantage.
• Strong written and oral communication skills and ability to collaborate effectively with others.
• Strong interpersonal, leadership and influencing Skills, communication and motivation.
• Drives for Superior Results and Passion to Win with demonstrated record in getting things done.
• Inspires Continuous Improvement and Breakthrough Thinking – flexible and adaptable to new and innovative ideas.