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- Tasks: Lead and support manufacturing operations in the pharmaceutical industry.
- Company: Join a world-class company delivering high-quality medicines globally.
- Benefits: Enjoy a culture of innovation and continuous improvement with opportunities for growth.
- Why this job: Make a real impact on health outcomes while working with cutting-edge technology.
- Qualifications: Requires a level 8 qualification in engineering or science and 3 years of relevant experience.
- Other info: Experience with FDA/EU regulations and project management skills are essential.
The predicted salary is between 36000 - 60000 £ per year.
Manufacturing Process Specialist
Skills, Experience, Qualifications, If you have the right match for this opportunity, then make sure to apply today.
Team Horizon is seeking a Manufacturing Process Specialist for a client in Sligo to support Pharmaceutical Operations and provide technical leadership and direction for the manufacturing department across several areas including formulation, aseptic filling process, isolator technology and representation at various regulatory audits.
Why you should apply:
* This is an excellent opportunity to join a world class manufacturing operation, with an outstanding track record of reliably delivering high-quality medicines to patients around the world suffering serious illnesses.
* There is a strong culture of continuous improvement and innovation within the company to strive for solutions that improve health outcomes and dramatically improve people’s lives.
* Our client is developing the capability to produce all its medicines, helping to ensure continuity of supply of our medicines as they expand internationally.
What you will be doing:
* On site ownership of manufacturing equipment, process knowledge and technology
* Sourcing and procuring process equipment including technical oversight of procurement process.
* Provide technical support for the Manufacturing Process and Equipment Collaborate with technical groups and experts across the network, ensuring consistency of technical approach and technical standards to strive for best-in-class performance.
* Design and implement technical studies and programs as appropriate to support investigations and product improvements.
* Develop knowledge of new pharmaceutical manufacturing processes as required in line with company business objectives.
* Identify and project manage continuous improvement projects. Collaborate closely with all leaders to monitor and where necessary implement improvement initiatives in line with continuous improvement philosophy.
* Continuously drive to improve processes for improved performance and cost reduction wherever possible.
* Establish/confirm specifications for process parameters, process controls and equipment effectiveness.
* Establish and maintain statistical process control systems in collaboration with Manufacturing and Quality functions.
* Monitor and analyse process data during the manufacturing of drug product.
* Oversight of planning, executing, and reporting for all process related aspects of technology transfer projects.
* Support the introduction of new products and process to site, working alongside all functions.
* Lead teams on identifying root cause and corrective actions for process deviations using best practice problem solving and continuous improvement methodologies in collaboration with other functions.
* Assuming accountability for risk assessments, including hazards, for the health and safety of company employees and visitors.
* Develop and modify procedures as needed to support the manufacturing operation.
* Participate in process, equipment, and facilities validations efforts and projects implementations.
* Consult with operations, quality, and S&T to ensure equipment and process performance is maximized.
* Adhere to all relevant policies relating to Quality & Safety.
* Ensure successful external inspections, and Division and Corporate audits.
* Supervision of external contractors.
What you need to apply:
* A relevant third level qualification in science, engineering, or technical discipline. Master’s or PhD in engineering, chemical or process engineering would be an advantage.
* Minimum of 3 years’ experience in pharmaceutical process engineering, with relevant experience of batch processing, technical transfers, scale-up, commissioning and validation in a cGMP pharmaceutical or Biologics industry
* Demonstrated project management skills, including the ability to deliver projects on schedule, within budget, and meeting the predefined quality requirements
* Previous experience in lyophilization and sterilization operations is preferable
Manufacturing Process Specialist employer: Team Horizon
Contact Detail:
Team Horizon Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Manufacturing Process Specialist
✨Tip Number 1
Familiarize yourself with the latest trends and technologies in pharmaceutical manufacturing, especially in aseptic filling processes and isolator technology. This knowledge will not only help you stand out during interviews but also demonstrate your commitment to continuous improvement.
✨Tip Number 2
Network with professionals in the pharmaceutical industry, particularly those who have experience in process validation and cGMP environments. Engaging with these experts can provide valuable insights and potentially lead to referrals for the Manufacturing Process Specialist position.
✨Tip Number 3
Prepare to discuss specific examples of your past experiences with technical writing and project management. Highlighting your achievements in leading investigations and managing projects will showcase your ability to meet the demands of this role.
✨Tip Number 4
Stay updated on FDA and EU regulations related to manufacturing and process engineering. Being knowledgeable about these quality systems will not only enhance your application but also prepare you for discussions during the interview process.
We think you need these skills to ace Manufacturing Process Specialist
Some tips for your application 🫡
Understand the Role: Make sure you fully understand the responsibilities and requirements of the Manufacturing Process Specialist position. Highlight your relevant experience in pharmaceutical process engineering, technical writing, and project management in your application.
Tailor Your CV: Customize your CV to reflect the specific skills and experiences that align with the job description. Emphasize your qualifications in engineering or science, as well as your experience with cGMP processes and regulatory compliance.
Craft a Strong Cover Letter: Write a compelling cover letter that showcases your passion for the pharmaceutical industry and your commitment to continuous improvement. Mention specific examples of how you've contributed to process improvements or led investigations in previous roles.
Highlight Technical Expertise: In your application, be sure to detail your technical expertise in formulation, aseptic filling processes, and isolator technology. Provide examples of how you've successfully managed equipment and process knowledge in past positions.
How to prepare for a job interview at Team Horizon
✨Showcase Your Technical Expertise
As a Manufacturing Process Specialist, you'll need to demonstrate your deep understanding of formulation, aseptic filling processes, and isolator technology. Be prepared to discuss specific examples from your past experiences where you successfully applied this knowledge.
✨Highlight Continuous Improvement Projects
The company values a culture of continuous improvement. Share instances where you've identified process inefficiencies and implemented solutions that led to enhanced performance or cost reduction. This will show your proactive approach and alignment with their values.
✨Prepare for Regulatory Discussions
Since you'll represent the team at regulatory audits, it's crucial to be familiar with FDA and EU regulations related to manufacturing. Brush up on your knowledge of quality systems and be ready to discuss how you've navigated compliance in previous roles.
✨Demonstrate Project Management Skills
With a focus on delivering projects on schedule and within budget, be ready to talk about your project management experience. Use specific examples to illustrate how you've successfully managed timelines, resources, and quality requirements in past projects.
