Roles & Responsibilities

Job Title

CQV Engineer – CIP /Cleaning Validation

About PDP
Project Delivery Partners (PDP) is a specialized project delivery consulting company encompassing strong project management and technical expertise; providing services to high technology sectors with particular focus on Biopharmaceutical/Pharmaceutical.

Job Description:

Specific experience

• Perform risk assessments and GAP analysis for site cleaning programmes
• Creating cycle development strategies for a variety of equipment
• Perform spray coverage testing and cleaning verification
• Perform flow calculations for determination of fluid velocities
• Experience with Delta V system

General Experience

• Walk down, review construction package and execute commissioning and qualification for bio process systems.
• Ensure all the safety documents, i.e. Method Statements, SPA, etc. are prepared and approved prior to the commencement of execution activities.
• Raising of any change controls and deviations and discussing same with SMEs and client reviewers.
• Notify project management, in a timely manner, of all relevant issues which may impact on system progress. Coordinate with design SMEs and/or project teams to resolve any identified technical issues.
• Ensure that all works carried out on your scope or responsibility by construction, commissioning and contract team members are performed in accordance with site safe working practices.
• Ensure that system delivery progresses in accordance with the approved project schedule.
• Ensure the cohesive operation of your cross-functional team and coordinate work for effective and efficient completion.
• Coordinate & lead cross functional project teams for the Installation, Commissioning & Qualification based on planned timelines and scope.
• Facilitate the completion of outstanding construction punch items through required safety procedures and permits.
• Confirm the site installation is as per approved design specification and meet system IQ requirements.
• Act as the technical liaison with System vendors for support and/or, on site attendance, as required, throughout the Commissioning & Qualification process.

Education and Experience

• Candidate should hold at minimum a Bachelor’s Degree in Engineering/ Science.
• Minimum 5 years’ relevant experience in commissioning and qualification activities for projects in pharmaceutical facilities.
• Strong knowledge and experience of Commissioning and Qualification.
• Knowledge of recent regulations (ICH, ASTM, FDA, ISPE) and modern CQV practices.
• Have a thorough understanding of the full project lifecycle.
• Excellent communication and organisational skills with demonstrated capability to effectively communicate with all levels of the organisation is required.
• Have clear communication & people skills.
• Demonstrate time and people management and decision-making skills.
• Strong oral and written communications skills.
• Ability to foster collaboration and work effectively on cross-functional teams.

Tell employers what skills you have

FDA
Construction
Spa
Cleaning Validation
Written Communications
Project Management
Consulting
Technical Liaison
Project Delivery
GAP
Commissioning
People Management