Global Validation Engineering Leader

West Pharmaceutical Services; Greenfield (IN); On-site; USD 117,000 - 150,000; Full time

Job summary

West Pharmaceutical Services seeks an experienced Validation Engineer to lead the development and execution of validation strategies for Global Technical Operations. You will ensure qualification of equipment, facilities, utilities, automated systems, and processes in line with GMP and industry standards.

Reporting to the Director of Global Validation and Metrology Services, you will drive risk-based validation, mentor teams, and harmonize standards across sites while managing site validation

Qualifications

• Must have a third level qualification, at a minimum to degree level, in Computer Science, Engineering or related fields.
• Must have 10 years of validation engineer experience in a cGMP regulated industry.
• Must have a minimum of 10 years post graduate experience of working in a high-volume manufacturing environment ideally in the Medical Device / Pharmaceutical sector.

Responsibilities

• Provide technical leadership and direction to a globally dispersed Validation Engineering team with responsibility for defining strategy, planning and execution of Validation activities within the Global Technical Operations network.
• Provide strategic leadership of long-term and intermediate goals the Global Technical Operations Network.
• Direct resources from functional responsibility for Validation in support of programs within the Global Technical Operations Network.
• Participate in the harmonization and implementation of Validation standards and procedures across the Global Technical Operations network based on current regulations, industry standards and industry practices.
• Drive innovative and efficient approaches to validation incorporating science and risk-based approach.
• Oversee the preparation, review, and approval of Site Validation Master Plans.
• Review and or approval of qualification and/or validation documentation (specifications, protocols, reports etc.) in relation to instrument, equipment, facilities, utilities, automated systems, manufacturing processes and cleaning processes including FAT, SAT, IQ, OQ, PQ phases in conjunction with program Quality representation.
• Oversight of third party generated protocols and reports in conjunction with program Quality representation.
• Fosters and encourages shared learning’s across the organisation e.g. system and technology best practices.
• Chair, schedule and minute validation meetings and participate in meetings when required.
• Perform periodic reviews of systems in order to maintain validation status.

Skills

ISO 13485

EU GMP

CFR Part 820

Plastic process manufacturing

Computer validation

Analytical methods

Documentation systems

Education

Bachelor's degree in Computer Science, Engineering or related fields

Job description

West Pharmaceutical Services seeks an experienced Validation Engineer to lead the development and execution of validation strategies for Global Technical Operations. You will ensure qualification of equipment, facilities, utilities, automated systems, and processes in line with GMP and industry standards.

Reporting to the Director of Global Validation and Metrology Services, you will drive risk-based validation, mentor teams, and harmonize standards across sites while managing site validation