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- Tasks: Join us as a Bioprocess Engineer to support cutting-edge drug manufacturing projects.
- Company: Piramal Pharma Solutions is a global leader in advanced drug development and manufacturing.
- Benefits: Enjoy competitive pay, career growth opportunities, and a dynamic work environment.
- Why this job: Be part of a revolutionary team making a real impact in the pharmaceutical industry.
- Qualifications: Experience in GMP biologics manufacturing and strong project management skills are essential.
- Other info: This role is based in our new £45 million facility in Grangemouth.
The predicted salary is between 36000 - 60000 £ per year.
Piramal Pharma Solutions is a leading global CDMO of advanced drug development and manufacturing solutions to the pharmaceutical industry. We are expanding with our new 45 million pound facility in Grangemouth and have a need for a Bioprocess Engineer (MSAT) to support our projects.
Responsible for the technology transfer of both new and repeat Antibody Drug Conjugate (ADC) processes from Process Development to Manufacturing in compliance with Good Manufacturing Practices (GMP), including generation of all required process and technical documentation. Work compliantly within Piramal Quality Management System (QMS) to ensure processes meet company and regulatory requirements. Lead and manage implementation of improvement actions identified through CAPA actions and end of campaign lessons learned.
Key Roles/Responsibilities:- Prepare GMP batch records for use in GMP manufacturing processes.
- Review, approve, and issue manufacturing documentation.
- Determine scale-up criteria from development to manufacturing scale.
- Generate process mass balances and flow diagrams.
- Identify, design and define large scale manufacturing equipment.
- Define materials for use in a GMP manufacturing environment.
- Generate quality documentation for raw materials and equipment.
- Work within the Piramal quality system to initiate, manage and evaluate requests for change.
- Perform investigations, close CAPA’s and deviations.
- Project manage all aspects of the introduction of processes to manufacturing.
- Perform risk assessments in alignment with ICH 9Q.
- Evaluate process materials for suitability for use in manufacturing.
- Proven GMP Biologics manufacturing or process development experience.
- Strong planning and organization skills to influence and gain support from key stakeholders that collaborate to deliver technical transfer projects.
- Strong project management skills.
- Process scale-up, transfer and manufacturing support.
- A proven track record to meet project deadlines.
- Ability to communicate with vast cross sections of people at all levels of the business.
- Evaluation of materials for process suitability.
- Writing GMP batch records.
- Commercialisation of biological medicines and process validation.
- Experience of process improvement and process mapping.
- Definition, sourcing, and validation of large-scale process equipment.
Bioprocess Engineer (MSAT) employer: Career Wallet
Contact Detail:
Career Wallet Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Bioprocess Engineer (MSAT)
✨Tip Number 1
Familiarise yourself with Good Manufacturing Practices (GMP) and the specific regulations that apply to bioprocess engineering. Understanding these guidelines will not only help you in interviews but also demonstrate your commitment to compliance and quality.
✨Tip Number 2
Network with professionals in the biopharmaceutical industry, especially those who have experience in technology transfer and process development. Attend relevant conferences or webinars to make connections and learn about the latest trends and challenges in the field.
✨Tip Number 3
Prepare to discuss specific projects where you've successfully managed process scale-up or improvement actions. Be ready to share examples of how you’ve navigated challenges and collaborated with cross-functional teams to achieve project goals.
✨Tip Number 4
Research Piramal Pharma Solutions and their recent projects, particularly the new facility in Grangemouth. Understanding their operations and values will allow you to tailor your conversations and show genuine interest in contributing to their success.
We think you need these skills to ace Bioprocess Engineer (MSAT)
Some tips for your application 🫡
Understand the Role: Take time to thoroughly read the job description for the Bioprocess Engineer (MSAT) position at Piramal Pharma Solutions. Understand the key responsibilities and essential experience required, so you can tailor your application accordingly.
Highlight Relevant Experience: In your CV and cover letter, emphasise your proven GMP biologics manufacturing or process development experience. Be specific about your project management skills and any relevant achievements that demonstrate your ability to meet project deadlines.
Showcase Technical Skills: Make sure to include any technical skills related to process scale-up, technology transfer, and the generation of GMP batch records. Mention any experience with quality documentation and risk assessments, as these are crucial for the role.
Craft a Strong Cover Letter: Write a compelling cover letter that connects your background to the specific needs of Piramal Pharma Solutions. Discuss how your skills align with their requirements and express your enthusiasm for contributing to their new facility in Grangemouth.
How to prepare for a job interview at Career Wallet
✨Understand GMP and QMS
Make sure you have a solid grasp of Good Manufacturing Practices (GMP) and the Quality Management System (QMS) used by Piramal Pharma Solutions. Be prepared to discuss how your previous experience aligns with these standards, as they are crucial for the role.
✨Showcase Your Project Management Skills
Highlight your project management experience, especially in technical transfer projects. Be ready to provide examples of how you've successfully managed timelines, resources, and stakeholder communication in past roles.
✨Prepare for Technical Questions
Expect to answer technical questions related to bioprocess engineering, such as scale-up criteria and process mass balances. Brush up on your knowledge of Antibody Drug Conjugates (ADCs) and be ready to discuss relevant processes you've worked on.
✨Demonstrate Problem-Solving Abilities
Be prepared to discuss how you've handled challenges in previous roles, particularly in relation to CAPA actions and process improvements. Use specific examples to illustrate your problem-solving skills and your ability to learn from past experiences.
