At a Glance
- Tasks: Lead cleaning validation and manage technical operations projects in a dynamic environment.
- Company: Join Organon, a global healthcare leader focused on women's health.
- Benefits: Inclusive workplace with opportunities for professional growth and development.
- Other info: Collaborative culture with a commitment to diversity and inclusion.
- Why this job: Make a real impact on health solutions that improve lives every day.
- Qualifications: Experience in cleaning validation and a degree in Science or Engineering.
The predicted salary is between 50000 - 65000 £ per year.
This job is with Organon, an inclusive employer. Organon is hiring a Senior Process Engineer/Scientist to join our world class manufacturing site in Cramlington, Northumberland. In this role, you will be responsible for the management and execution of Technical Operations projects which can include technical transfers, new equipment, supplier item qualification, cleaning and continuous improvement initiatives.
The successful candidate will provide leadership, governance, and technical expertise to ensure that projects or activities impacting Technical Operations are delivered safely, compliantly and in line with required timelines and budget.
Role Responsibilities- Lead the site Cleaning Validation Program, including development, execution and lifecycle management of cleaning validation and cleaning verification activities for manufacturing and packaging equipment.
- Manage complex investigations and follow up issues arising from deviations, establishing assignable causes for atypical events and propose appropriate actions to improve process capability.
- Develop strategies for validation activities on site, provide technical manufacturing assistance with the preparation of validation protocols and oversee in-process validation sampling.
- Lead site compliance with the standards in policies, procedures, guidelines and SOPs and comment / author as appropriate.
- Coordinates/Mentors/Implements training of other members of the Technical Services group and educating other areas on the roles and responsibilities of Technical Services.
- Lead Operational Excellence activities - continuous improvement, systems robustness with use of appropriate LSS tools and innovative mindset.
- Significant experience in cleaning validation within a GMP pharmaceutical manufacturing environment.
- Demonstrable knowledge of regulatory expectations relating to cleaning validation, including EU GMP Annex 15, PIC/S guidance, FDA guidance and risk based approaches to setting cleaning limits.
- Demonstrable experience in Pharmaceutical manufacturing, preferably in a process support environment.
- Degree in Science or Engineering Discipline or equivalent.
- Proven ability to communicate, influence and work effectively in both individual and cross functional environment.
- Effective time management and organisation skill to aid prioritisation, resource allocation and meet project deadlines.
- Proven logical, analytical approach to problem solving with high complexity with good root cause analysis to develop new systems and ways of working, utilising Lean Six Sigma principals.
Senior Process Engineer/Scientist in Northumberland employer: Organon
At Organon, we pride ourselves on being an exceptional employer, offering a dynamic work culture that fosters collaboration and innovation. Our Cramlington site not only provides competitive benefits and opportunities for professional growth but also encourages employees to take ownership of their roles in ensuring the highest quality standards in pharmaceutical manufacturing. Join us to be part of a team that values your contributions and supports your career development in a meaningful way.
StudySmarter Expert Advice🤫
We think this is how you could land Senior Process Engineer/Scientist in Northumberland
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Get involved with organisations such as the Royal Pharmaceutical Society or your local pharmaceutical professionals' network. Being an active member can boost your credibility and may even lead to job referrals in top organisations like Organon.
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We think you need these skills to ace Senior Process Engineer/Scientist in Northumberland
Some tips for your application 🫡
Showcase Your Relevant Experience:When applying for a role in the pharmaceutical industry, it's crucial to highlight any relevant experience you have. Whether that's internships, lab work, or even related coursework, make sure to weave this into your CV and cover letter. We want to see how your background aligns with the role you're applying for at Organon!
Emphasise Your Understanding of Regulations:The pharmaceutical industry is heavily regulated, so it's important to indicate your familiarity with industry standards and regulations. In your cover letter, mention any training or certifications you've received that are relevant, or discuss projects where you’ve navigated compliance. This will show Organon that you're not just a fit for the job but also a safety-conscious candidate!
Tailor Your CV to Be Result-Driven:Craft your CV to highlight quantifiable achievements, especially if you have previous roles in pharmaceuticals or related fields. Use metrics to demonstrate your impact, such as improved processing times or successful project completions while working on trials. This analytical approach will resonate well with hiring managers at Organon!
Convey Your Passion for the Industry:In your cover letter, express why you are passionate about working in the pharmaceutical sector. Whether it’s your desire to contribute to groundbreaking drug research or improve patient outcomes, let it shine through! At Organon, we value candidates who are truly enthusiastic about their work—you might just stand out from the crowd.
How to prepare for a job interview at Organon
✨Understand the Science
Make sure you brush up on key pharmaceutical concepts and recent developments in the industry. You might get asked some technical questions during the interview at Organon that show your grasp of drug development processes or regulatory requirements, so be ready to discuss them clearly.
✨Showcase Relevant Experience
If you have any hands-on experience or internships in a laboratory setting, be sure to highlight these in your responses. Think about the projects you worked on, the methodologies you used, and the impact you made. It's all about telling a story that connects your background to the role you're applying for.
✨Know Their Products
Take some time to familiarise yourself with Organon’s product range and recent breakthroughs. Understanding their portfolio not only shows your enthusiasm for the role but also allows you to ask insightful questions that demonstrate your interest in actively contributing to their projects.
✨Be Ready for Regulatory Scenarios
In a full-time pharmaceutical role, understanding the regulatory landscape is crucial. Prepare for situational questions that may test your problem-solving skills concerning compliance and safety standards. You could be asked how you'd handle a hypothetical issue regarding a drug’s market release, so think through your approach.
