We're currently on the lookout for Validation Engineers for the Pharmaceutical Industry.
Candidates should possess the following skillset :
- Developing and executing validation protocols for new processes, equipment, and systems, including installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ).
- Reviewing and approving validation documentation, including validation plans, protocols, reports, and standard operating procedures (SOPs).
- Conducting risk assessments and developing mitigation strategies to minimize risks associated with validation activities.
- Collaborating with cross-functional teams, including Engineering, Quality Assurance, and Production, to ensure validation activities are aligned with project timelines and requirements.
- Conducting equipment and process performance studies, including data analysis and interpretation.
- Troubleshooting and resolving validation issues and deviations, ensuring compliance with regulatory guidelines and company standards.
- Providing technical support and guidance to production teams to ensure adherence to validated processes and procedures.
- Conducting periodic reviews and revalidation of processes, equipment, and systems to ensure continued compliance and efficiency.
- Keeping up-to-date with industry regulations, guidelines, and best practices related to validation activities.
- Participating in internal and external audits and inspections, providing validation-related documentation and supporting evidence.
Candidates should also possess the following qualifications :
- Bachelor's degree in Engineering, Pharmacy, or a related field.
- Strong knowledge of pharmaceutical manufacturing processes, equipment, and systems.
- Prior experiences in Bio/API plants in the pharmaceutical industry.
- Familiarity with regulatory guidelines and standards relevant to pharmaceutical validation (e.g. GMP)
- Excellent analytical and problem-solving skills, with the ability to interpret data and identify root causes of issues.
- Strong attention to detail and organizational skills to manage multiple validation projects simultaneously.
- Effective communication and interpersonal skills to collaborate with cross-functional teams and stakeholders.
- Proficiency in validation tools and software, as well as Microsoft Office Suite.
- Knowledge of statistical analysis and validation software is a plus.
- Prior experience working in a regulated industry, such as pharmaceuticals, biotechnology, or medical devices, is preferred.
- Certification in validation or quality-related disciplines, such as Six Sigma or Quality Engineering, is advantageous.
