Validation Engineer
SoTalent
About the role
About
Our client is seeking a Validation Engineer to support compliance and quality within a regulated manufacturing setting. This position focuses on ensuring that systems, equipment, and processes meet stringent industry and regulatory requirements. It’s a hands-on role suited to someone with experience in validation within GMP-regulated environments.
Key Responsibilities
- Develop and implement validation strategies, including protocols, risk assessments, and qualification plans
- Serve as a subject matter expert on validation, advising cross-functional teams and supporting operational decision-making
- Lead or contribute to validation activities tied to change controls, capital projects, and ongoing compliance initiatives
- Collaborate with departments such as Engineering, Manufacturing, Quality, IT, and Supply Chain to manage priorities and improve efficiency
- Execute validation tasks independently, occasionally taking ownership of projects within the validation function
- Respond to equipment qualification requests and ensure timely delivery of validation support
- Promote a culture focused on quality, compliance, and continuous improvement
- Stay informed on relevant regulatory standards and ensure ongoing adherence
- Participate in audits and inspections, representing validation processes when required
- Oversee qualification of laboratory and production equipment, including analytical tools and monitoring systems
- Apply risk-based approaches to improve validation timelines without compromising quality
- Identify and implement opportunities to enhance validation processes and operational efficiency
- Support training initiatives to strengthen team capability in validation practices
Skills and Experience
- Degree in engineering, life sciences, or a related STEM discipline
- At least 2 years of experience in commissioning, qualification, and validation within regulated industries
- Strong understanding of GMP and associated frameworks (e.g., data integrity, computer system validation, and regulatory guidelines)
- Practical experience with equipment, facility, and utility qualification processes
- Familiarity with deviation management, investigations, and corrective/preventive actions is advantageous
- Knowledge of validation lifecycle documentation, from initial requirements through to final qualification and system retirement
- Strong organisational, communication, and technical writing skills
- Experience using electronic systems for managing quality and validation documentation is beneficial
- Ability to represent technical work confidently to internal stakeholders and external auditors
- Background in pharmaceutical or biopharmaceutical environments preferred
Working Style
This role suits someone detail-oriented with a proactive mindset, capable of working both independently and collaboratively. A willingness to learn, support colleagues, and continuously improve processes is highly valued.
Rewards and Benefits
The position offers a competitive salary along with potential performance-based incentives. A comprehensive benefits package is provided, which may include healthcare coverage, financial protection plans, wellbeing programs, and retirement savings options.
Employees may also benefit from flexible time-off policies, paid holidays, and additional leave options depending on eligibility. Work-life balance is supported through various initiatives, including flexible scheduling and wellbeing resources.
Skills
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