Validation Coordinator

Walker Cole International is supporting a leading pharmaceutical manufacturer in the appointment of a Validation Engineer to support validation and compliance activities across a GMP-regulated manufacturing environment.

This position will focus on delivering validation lifecycle activities across pharmaceutical manufacturing processes, equipment, utilities and computerised systems, ensuring systems and processes remain compliant with regulatory and operational requirements. The successful candidate will work closely with Quality, Engineering, Manufacturing and Automation teams to support ongoing projects and site compliance initiatives.

Key responsibilities:

• Deliver full validation lifecycle activities including Risk Assessments, Validation Plans, URS, IQ/OQ/PQ protocols, Traceability Matrices, Validation Reports and SOPs.
• Support process, equipment, cleaning and computer system validation activities across GMP manufacturing operations.
• Assist with development, maintenance and execution of Site Validation Master Plans (VMPs).
• Perform quality and compliance gap assessments relating to validation and GMP activities.
• Support validation activities across manufacturing equipment, packaging systems, utilities and automated systems.
• Participate in commissioning, qualification and ongoing lifecycle management activities for validated systems and equipment.
• Manage deviations, CAPAs and change controls associated with validation activities.
• Collaborate with QA, Production, Engineering and Automation teams to ensure compliant project delivery and operational readiness.
• Support regulatory inspections and ensure validation documentation remains audit-ready.
• Provide guidance and training on validation principles and compliance requirements where required.

Required experience and skills:

• Proven experience delivering validation activities within GMP-regulated pharmaceutical environments.
• Strong understanding of validation lifecycle methodologies across process, equipment, cleaning and CSV validation.
• Experience writing and executing validation documentation including IQ/OQ/PQ protocols and validation reports.
• Familiarity with GMP, GLP, MHRA, FDA, EMA, ICH and Data Integrity requirements.
• Strong understanding of risk-based validation approaches including FMEA and Risk Assessments.
• Knowledge of computerised systems validation and 21 CFR Part 11 requirements is desirable.
• Experience with HVAC systems, water systems, environmental monitoring or critical utilities is advantageous.
• Understanding of automation and control systems within pharmaceutical manufacturing environments is desirable.
• Experience with validation software systems such as SAP, LIMS or electronic validation platforms is beneficial.
• Strong communication, stakeholder management and problem-solving skills within cross-functional environments.
• Ability to manage validation projects through planning, execution and close-out phases.

Working pattern:
Onsite 

Employment type:
Contract 

Location:
South East, England, United Kingdom

Keywords:
Validation Engineer | GMP | Pharmaceutical | IQ OQ PQ | CSV | Process Validation | Cleaning Validation | Equipment Validation | GAMP 5 | FDA | MHRA | Annex 11 | Data Integrity | HVAC | Utilities | CQV | Compliance | Validation Lifecycle