Job ID :
40252BR
Location :
United Kingdom - Horsham
:
Job Description
Key Responsibilities:
Minimum Requirements/Qualifications: (Bullets)
Non-Negotiable Hiring Criteria: (Bullet 3-5 key quantifiable skills or position requirements that the candidate must have to be considered for this position.)
Job Title: Senior Compliance and Validation Engineer
Reports To: Facilities and Engineering Director
Group/Division: BioPharma Services
Career Band: 8
Job Track: Management
Position Location: Horsham, UK
Number of Direct Reports: 2
Position Summary:
- To Manage and drive validation/qualification and change control activities for FCS Horsham Engineering and Facilities Department
- Manage all aspects of quality within the Facilities and Engineering Department
- Own and drive the Good engineering Practice management system
Key Responsibilities:
- To drive and own validation and qualification activities including equipment, facilities, systems,
- The preparation, review and issuing of Validation protocols
* Devise the relevant qualification and validation plan, URS, DQ,IQ,OQ,PQ , FAT,SAT, Traceability Matrix, and summary reports
* Reviewing and approving the relevant documents on validation processes and quality attributes of the department
* Ensure that the Validation / Qualification and quality systems are working in accordance with any changing and current regulations.
- To support change control activities, deviations and SOP’s within equipment and facilities,
- To coordinate validation/qualification and change control activities
- With direct reports, be responsible and accountable for all equipment and facilities qualification plans and Good Engineering Practices
- Manage the quality aspects within all internal facilities and engineering projects
Minimum Requirements/Qualifications: (Bullets)
- Bachelor’s Degree in Quality Assurance, Electrical Engineering, Mechanical Engineering, Biomedical Engineering, or degree in biological science, or extensive career history within this or equivalent role
- Strong technical proficiency of Quality Management Systems with focus on Engineering qualification / validation functions
Non-Negotiable Hiring Criteria: (Bullet 3-5 key quantifiable skills or position requirements that the candidate must have to be considered for this position.)
- Ability to work within a team providing support to other members
- Ability to work without direct supervision, on own initiative within the remit of the role
- The successful Senior Validation Engineer will need to demonstrate management in validation and qualification within a Pharmaceutical or GMP environment
- This role will require excellent communication skills
- High degree of accuracy, concentration, verbal and written communication
