job description
Join Elitez Group as a Validation Engineer and play a pivotal role in ensuring the highest standards of compliance and quality in pharmaceutical and biopharmaceutical facilities. Based in the vibrant regions of Bali, this position offers a unique opportunity to work in a dynamic environment while contributing to critical validation processes that uphold global regulatory standards.
As a Validation Engineer, you will be responsible for executing Commissioning, Qualification, and Validation (CQV) activities, ensuring adherence to Good Manufacturing Practices (GMP) and other regulatory requirements. Your expertise will directly impact the safety, efficacy, and compliance of life-saving pharmaceutical products.
This role is ideal for professionals passionate about quality assurance, regulatory compliance, and continuous improvement in the healthcare sector. If you thrive in a detail-oriented, fast-paced environment and are eager to advance your career in validation engineering, we invite you to apply.
Responsibility
- Execute and oversee Commissioning, Qualification, and Validation (CQV) activities for pharmaceutical and biopharmaceutical facilities.
- Ensure compliance with GMP, FDA, EMA, and other regulatory standards throughout the validation lifecycle.
- Develop, review, and approve validation protocols, reports, and documentation.
- Collaborate with cross-functional teams, including engineering, quality assurance, and production, to ensure seamless validation processes.
- Identify and mitigate risks associated with validation activities, ensuring timely resolution of deviations.
- Conduct gap analyses and implement corrective actions to maintain compliance with evolving regulatory requirements.
- Provide training and guidance to team members on validation best practices and regulatory expectations.
- Support audits and inspections by regulatory authorities, ensuring readiness and compliance at all times.
Qualifications
- Bachelor’s degree in Pharmaceutical Sciences, Chemical Engineering, Biochemistry, or a related field.
- Minimum of 3-5 years of experience in validation engineering within the pharmaceutical or biopharmaceutical industry.
- In-depth knowledge of GMP, FDA 21 CFR Part 11, EU GMP, and ICH guidelines.
- Proven experience in developing and executing validation protocols (IQ, OQ, PQ) and risk assessments.
- Strong analytical and problem-solving skills with a keen attention to detail.
- Excellent communication and interpersonal skills to collaborate effectively with multidisciplinary teams.
- Certification in validation or quality assurance (e.g., ASQ, ISPE) is a plus.
- Ability to work independently and manage multiple projects in a fast-paced environment.