Senior Validation Lead

Kelly Science, Engineering, Technology & Telecom; Södertälje kommun; Presencial; SEK 900.000 - 1.200.000; Jornada completa

Descripción de la vacante

Kelly Science, Engineering, Technology & Telecom seeks a Senior Validation Lead for pharmaceutical manufacturing in Sweden. You will own qualification and validation activities across packaging lines, equipment and systems, ensuring GMP compliance and adherence to GAMP 5 and internal quality standards.

The role involves coordinating cross-functional teams with Production, Engineering, Quality and Automation to translate regulatory requirements into practical manufacturing solutions and

Formación

• Experience leading qualification and validation of pharmaceutical packaging and manufacturing processes.
• Strong knowledge of GMP requirements and regulatory expectations.
• Ability to translate regulatory and quality requirements into practical manufacturing solutions.

Responsabilidades

• Lead qualification and validation activities for pharmaceutical packaging lines, equipment and related systems.
• Own validation across technical changes, investment projects, equipment modifications and lifecycle initiatives.
• Ensure qualification and validation activities comply with GMP, GAMP 5, internal standards and applicable regulations.
• Prepare, review and approve URS, IQ/OQ/PQ documentation, validation plans and reports.
• Coordinate cross-functional validation teams and external suppliers.

Conocimientos

Qualification & validation

GMP compliance

GAMP 5

Cross-functional collaboration

Descripción del empleo

Senior Validation Lead – Pharmaceutical Manufacturing

Location: Sweden

Potential: Opportunity to extend

Employment Type: Full-Time

Language: Swedish and English

About the Assignment

We are seeking an experienced Senior Validation Lead to join a major global pharmaceutical organisation and take responsibility for qualification and validation activities within a technology-intensive manufacturing and packaging environment.

This is a key role supporting packaging operations, technical investments, equipment lifecycle management, automation and continuous improvement initiatives. You will ensure that equipment, processes and technical changes are appropriately qualified and validated in accordance with GMP requirements, regulatory expectations and internal quality standards.

You will work closely with a broad range of stakeholders including Production, Engineering, Quality, Automation, Project Management and external suppliers. The environment is fast-paced and project-driven, with ongoing investment in manufacturing technology and packaging capabilities.

The successful candidate will be comfortable taking ownership of validation activities from initial requirements definition through to approved implementation and will be able to translate regulatory and quality requirements into practical solutions for manufacturing operations.

Key Responsibilities:

• Lead qualification and validation activities for pharmaceutical packaging lines, equipment and associated systems.
• Take ownership of validation activities across technical changes, investment projects, equipment modifications and continuous improvement initiatives.
• Ensure qualification and validation activities comply with GMP, GAMP 5, internal quality standards and applicable regulatory requirements.
• Prepare, review and approve validation documentation, including:
• User Requirements Specifications (URS)
• IQ/OQ/PQ documentation
• Validation Plans and Protocols
• Validation Reports
• Supporting technical and quality documentation
• Support requirements definition and technical assessments relating to the procurement, installation, modification and lifecycle management of manufacturing and packaging equipment.
• Lead validation activities associated with serialisation, vision systems, labelling, track-and-trace and automated packaging solutions.
• Coordinate cross-functional validation teams and ensure activities rema