Manufacturing Validation Lead

R Dpartners; Geel; On-site; EUR 83,000 - 101,000; Full time

Job summary

R&D Partners is seeking a Manufacturing Validation Lead to oversee validation activities for transport and CMO-manufactured products. You will lead validation lifecycle efforts, ensuring GMP/GDP compliance and acting as a quality SME for regulatory submissions and audits.

Based in Belgium, the role requires collaboration with cross-functional teams, focus on Facilities, Utilities and Equipment, Process Validation, and Comparability, and fluency in English to communicate with US-based teams when

Qualifications

• Expertise in validation lifecycle approaches and risk-based qualifications.
• In-depth experience in equipment qualification, requalification, and shipping validation.
• Strong knowledge of cGMP, ISO13485, and MDSAP standards.
• Excellent oral and written communication skills in English, with attention to detail.
• Strong interpersonal, negotiation, and organizational skills.
• Ability to work independently and make informed decisions.
• Proficiency in digital tools and project management.
• Experience working with US-based teams is a plus.

Responsibilities

• Develop, review, approve, and execute transport validation plans, protocols, risk assessments, and reports.
• Review and approve CMO-generated qualification and validation protocols, data, and reports.
• Provide onsite or remote support during CMO study execution.
• Assess validation impacts from change controls, deviations, audit findings, and CAPAs.
• Support lifecycle management for CMO-manufactured products.
• Act as a Quality validation SME for regulatory submissions and Health Authority queries.
• Ensure compliance with worldwide regulatory requirements and corporate standards.
• Participate in internal and external audits as a validation quality SME.
• Contribute to Communities of Practice (COP) focused on FUE, Process Validation, and related areas.

Skills

Validation lifecycle

Risk-based qualification

Equipment qualification

GMP/GDP knowledge

English communication

Project management

Cross-functional collaboration

Independent decision making

US team collaboration

Job description

Join a high-impact role where your validation expertise will support regulatory success, product quality, and patient safety.

R&D Partners is seeking a Manufacturing Validation Lead to oversee validation activities for transport and CMO-manufactured products. This role involves lifecycle management, ensuring compliance with GMP/GDP standards, and acting as a Quality validation SME for regulatory submissions, audits, and inspections. The position requires cross-functional collaboration and participation in product core teams, with a focus on Facilities, Utilities, and Equipment (FUE), Process Validation, Control Strategy, and Comparability.

Please note that to be considered for this role you must have the right to work in this location.

Responsibilities:

• Develop, review, approve, and execute transport validation plans, protocols, risk assessments, and reports.
• Review and approve CMO-generated qualification and validation protocols, data, and reports.
• Provide onsite or remote support during CMO study execution.
• Assess validation impacts from change controls, deviations, audit findings, and CAPAs.
• Support lifecycle management for CMO-manufactured products.
• Act as a Quality validation SME for regulatory submissions and Health Authority queries.
• Ensure compliance with worldwide regulatory requirements and corporate standards.
• Participate in internal and external audits as a validation quality SME.
• Contribute to Communities of Practice (COP) focused on FUE, Process Validation, and related areas.

Key Skills and Requirements:

• Expertise in validation lifecycle approaches and risk-based qualifications.
• In-depth experience in equipment qualification, requalification, and shipping validation.
• Strong knowledge of cGMP, ISO13485, and MDSAP standards.
• Excellent oral and written communication skills in English, with attention to detail.
• Strong interpersonal, negotiation, and organizational skills.
• Ability to work independently and make informed decisions.
• Proficiency in digital tools and project management.
• Experience working with US-based teams is a plus.

Accountabilities:

• Implement standardized processes and tools at the local level.
• Act as the “Voice of the Customer” within the COP.
• Share best practices and propose process improvements for simplification and harmonization.
• Ensure timely completion of validation activities in collaboration with cross-functional teams.

Salary:

• €450.00 – €550.00/Day

For more information, please contact Grant Van Schalkwyk.