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- Tasks: Lead technology transfer for innovative drug processes and ensure compliance with industry standards.
- Company: Piramal Pharma Solutions, a global leader in drug development and manufacturing.
- Benefits: Competitive salary, career growth, and the chance to work in a state-of-the-art facility.
- Why this job: Make a real impact in the pharmaceutical industry while working on cutting-edge bioprocess technologies.
- Qualifications: Experience in GMP biologics manufacturing and strong project management skills.
- Other info: Join a dynamic team focused on innovation and quality in drug development.
The predicted salary is between 36000 - 60000 £ per year.
Piramal Pharma Solutions is a leading global CDMO providing advanced drug development and manufacturing solutions to the pharmaceutical industry. We are continuing our growth with the opening of our new £45 million facility in Grangemouth, and we are seeking a Bioprocess Engineer (MSAT) to support our expanding project portfolio.
In this role, you will be responsible for the technology transfer of both new and existing Antibody Drug Conjugate (ADC) processes from Process Development to Manufacturing, ensuring full compliance with Good Manufacturing Practices (GMP). You will generate all required technical and process documentation and work within the Piramal Quality Management System (QMS) to ensure adherence to company and regulatory standards. You will also lead and manage the implementation of improvements identified through CAPA actions and end-of-campaign reviews.
Key Responsibilities- Prepare GMP batch records for use in manufacturing operations.
- Review, approve, and issue GMP manufacturing documentation.
- Define scale-up criteria from development to manufacturing scale.
- Produce process mass balances and flow diagrams.
- Identify, design, and specify large-scale manufacturing equipment.
- Define materials required for GMP manufacturing.
- Generate quality documentation for raw materials and equipment.
- Initiate, manage, and evaluate change controls within the Piramal QMS.
- Conduct investigations and close CAPAs and deviations.
- Project manage all aspects of process introduction into manufacturing.
- Perform risk assessments in alignment with ICH Q9 guidelines.
- Assess process materials for suitability in manufacturing.
- Proven experience in GMP biologics manufacturing or process development.
- Strong planning and organisational skills, with the ability to influence and engage stakeholders involved in technology transfer.
- Demonstrated project management capability.
- Experience in process scale-up, technology transfer, and manufacturing support.
- Proven track record of meeting project deadlines.
- Strong communication skills, with the ability to work effectively across all levels of the organisation.
- Experience evaluating materials for process suitability.
- Experience writing GMP batch records.
- Experience with commercialisation of biological medicines and process validation.
- Process improvement and process mapping experience.
- Defining, sourcing, and validating large-scale process equipment.
Locations
Bioprocess Engineer (MSAT) in Falkirk, Grangemouth employer: Piramal Pharma Solutions
Contact Detail:
Piramal Pharma Solutions Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Bioprocess Engineer (MSAT) in Falkirk, Grangemouth
✨Tip Number 1
Network like a pro! Reach out to people in the industry, attend events, and connect on LinkedIn. You never know who might have the inside scoop on job openings or can put in a good word for you.
✨Tip Number 2
Prepare for interviews by researching Piramal Pharma Solutions thoroughly. Understand their projects, values, and recent news. This will help you tailor your answers and show that you're genuinely interested in the role.
✨Tip Number 3
Practice your technical skills and be ready to discuss your experience with GMP biologics manufacturing. Be specific about your past projects and how they relate to the Bioprocess Engineer role.
✨Tip Number 4
Don’t forget to apply through our website! It’s the best way to ensure your application gets noticed. Plus, it shows you’re serious about joining our team at Piramal.
We think you need these skills to ace Bioprocess Engineer (MSAT) in Falkirk, Grangemouth
Some tips for your application 🫡
Tailor Your CV: Make sure your CV is tailored to the Bioprocess Engineer role. Highlight your experience in GMP biologics manufacturing and any relevant project management skills. We want to see how your background aligns with our needs!
Craft a Compelling Cover Letter: Your cover letter is your chance to shine! Use it to explain why you're passionate about the role and how your skills can contribute to our team at Piramal Pharma Solutions. Keep it engaging and relevant to the job description.
Showcase Your Technical Skills: Don’t forget to mention your technical expertise, especially in areas like technology transfer and process scale-up. We’re looking for someone who can hit the ground running, so make sure we see that in your application!
Apply Through Our Website: We encourage you to apply directly through our website. It’s the best way to ensure your application gets into the right hands. Plus, it shows us you’re serious about joining our team!
How to prepare for a job interview at Piramal Pharma Solutions
✨Know Your GMP Inside Out
Make sure you brush up on Good Manufacturing Practices (GMP) before your interview. Understand how they apply to bioprocess engineering and be ready to discuss specific examples from your experience that demonstrate your compliance with these standards.
✨Showcase Your Project Management Skills
Prepare to talk about your project management experiences, especially in technology transfer and process scale-up. Have a couple of solid examples ready that highlight your ability to meet deadlines and manage stakeholders effectively.
✨Be Ready for Technical Questions
Expect technical questions related to antibody drug conjugates (ADCs) and the specifics of process documentation. Brush up on your knowledge of process mass balances, flow diagrams, and the equipment used in large-scale manufacturing.
✨Demonstrate Your Problem-Solving Skills
Think of instances where you've identified improvements through CAPA actions or end-of-campaign reviews. Be prepared to discuss how you approached these challenges and what the outcomes were, showcasing your analytical and critical thinking skills.