Job description
Work Your Magic with us!
Ready to explore, break barriers, and discover more? We know you've got big plans - so do we! Our colleagues across the globe love innovating with science and technology to enrich people's lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet. That's why we are always looking for curious minds that see themselves imagining the unimaginable with us.
Your Role:
We have an exciting opportunity for a Validation Engineer to join the team within the Livingston site. As part of the validation team, you will be required to Support, maintain and execute the facility Validation Program to ensure that validation processes and procedures are in compliance with ISO9001; ISO13485; 21 CFR 600; IVDD 98/79/EC and other appropriate regulations and standards. This includes site safety requirements and applicable Good Manufacturing Practices (GMP).
Apply now and become a part of our diverse team!
Ready to explore, break barriers, and discover more? We know you've got big plans - so do we! Our colleagues across the globe love innovating with science and technology to enrich people's lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet. That's why we are always looking for curious minds that see themselves imagining the unimaginable with us.
Your Role:
We have an exciting opportunity for a Validation Engineer to join the team within the Livingston site. As part of the validation team, you will be required to Support, maintain and execute the facility Validation Program to ensure that validation processes and procedures are in compliance with ISO9001; ISO13485; 21 CFR 600; IVDD 98/79/EC and other appropriate regulations and standards. This includes site safety requirements and applicable Good Manufacturing Practices (GMP).
- Write and complete protocols and reports. Ensure compliance with quality standards and regulatory requirements and departmental and organisational objectives.
- Provide validation guidance and expertise for investigation of failures and participate in CAPA, customer complaints and continuous improvement initiatives.
- Support Corporate Initiatives as assigned, participate in cross functional teams to establish validation strategies and objectives to support Business expansion of facilities and processes, throughout the Corporation.
- Write and maintain procedures relating to Corporate and local Validation policy.
- Support the implementation of Validation Key Performance Indicator(s). Monitor trends and initiate Continuous Improvement opportunities. Escalate any out-of-norm matters to department management as applicable.
- Bachelors/Undergraduate Degree in a quality or science related discipline (chemistry, biology, or medical technology preferred).
- Five (5) years' experience in a drug manufacturing, medical device, or biologics industry in Validation, Quality Assurance or GMP manufacturing
- Previous experience should demonstrate expertise in, GMP, FDA regulations, SOP development, as well as an understanding of Validation and Data Integrity Principles.
- Analytical and problem-solving skills, including presentation of results into meaningful reports
- Competent in the use IT technology, such as Microsoft Word, Excel and PowerPoint.
- Good communication skills (written and verbal) with the ability to collaborate and present at all levels and functions of the organization
- Ability to work well within a team while being accountable for own actions and actively contribute to validation team objectives.
Apply now and become a part of our diverse team!
Merck KGaA
www.merckgroup.com
Darmstadt, Germany
Belén Garijo
$10+ billion (USD)
10000+ Employees
Company - Public
Biotech & Pharmaceuticals
1668