As a Validation Engineer you will be responsible for validating/qualifying the systems, equipment and utilities used in the development and clinical manufacture of a range of solid dosage forms.
An individual contributor role that applies technical, control system and engineering knowledge to the design and validation of new equipment, systems and utilities within the solid dose manufacturing area in Sandwich.
The role will also include some safety and management of the full asset lifecycle. You will help to design robust manufacturing solutions and demonstrate systems are running according to necessary specifications and operate within regulations to ensure data integrity and the production of quality products.
Colleagues will work closely with operational and technical teams within the department to validate equipment, utilities and systems. Colleague will be expected to interact with Global Workplace Solutions, Quality Assurance and Environmental Health and Safety to support the manufacture of solid oral dosage forms for clinical supply.
Main duties will include:
- Schedules and executes validations/qualifications per Standard Operating Procedures (SOPs), protocols and regulatory guidelines
- Coordinates and communicates all testing with affected functional groups and evaluates test results
- Executes validation activities to include Change Control initiation, protocol preparation, scheduling, Factory Acceptance Testing, protocol execution, data review and final report generation
- Responsible for completion of fully system lifecycle activities associated with equipment, utilities or facilities from project initiation through to retirement / re-designation
- Participate in development / improvements to the validation program as needed to remain current with cGMPs and industry standards
- Participates on teams assembled to specify, install, validate, troubleshoot and maintain systems and equipment
- Participates in deviation investigations to identify root causes and define corrective and/or preventative actions (CA/PA)
- Participate and present data in Regulatory Agency, Customer, Corporate and Internal audits when necessary
Other duties will include, but are not limited to:
- Provide support for additional focus area: Automation, Facility Support, Process Development, Capital Projects
- Assist in ensuring future equipment meet the technical requirements of the operation
- Contribute to the selection and integration of new equipment and services, ensuring validation, quality requirements and the process capability of the equipment is in line with pre-defined needs
- Support and develop equipment/services robustness and manage the risks and impact of failure
- Manage minor projects which include all operational and financial aspects. Drive quality, safety and continuous improvement related activities
- Deliver training and support to ensure efficient use and deployment of equipment
- Provide immediate troubleshooting and manufacturing support during manufacturing operations
You’re the future. Your ambition, talents, ideas and unique way of looking at the world will help us drive innovation in every part of our business.
We need people with a hugely diverse range of talents. Love science? Join us in our drug development labs, or engineering teams. Want to work on the business side? Get stuck into an Apprenticeship to launch a career in anything from digital marketing to paralegal services.
Pfizer’s apprenticeship scheme, run in partnership with Cogent Skills, offers the best of both worlds. You’ll work with world-leaders in your field, from researchers to business gurus. You’ll study towards a nationally recognised academic or professional qualification. And all the time, you’ll be earning a highly competitive salary.
Looking for an alternative to college or university, where you can earn while you learn, and build experience with a global leader? Find it at Pfizer.
Upon successful completion of the apprenticeship, candidates will be able to apply for further positions.
The apprentice must be able to demonstrate the required attitudes, behaviours and interpersonal skills associated with the professional workplace. The apprentice must be willing to commit an amount of personal time to study. Please ensure you check out travel options to be able to commute to the workplace.
You will be entitled to company benefits including;
- 25.5 Days Holiday entitlement (+ Bank Holidays)
- Opt in pension scheme
- Student discount card (NUS)
- Employee assistance programme
- Dedicated mentor for the duration of your apprenticeship
- Rational, innovative and creative approach to problem solving
- Ability to learn and work with new technologies
- Ability to work collaboratively and effectively within high performing teams as well as independently
- Good report writing and oral communication skills
- Ability to apply learning from prior experience to new situations and problems
- Ability to evaluate information from a broad range of sources
- Communicates with clarity, purpose and efficiently
- Enthusiastic attitude and approach to teamwork with positive influencing and listening skills
- High energy level; hard working; makes things happen
- Demonstrates sound judgement when making decisions
- Self-driven and able to set personal goals which are realistic and challenging
- Change agile, flexible and resilient
To be eligible for this position you will need:
- 5 GCSEs at grades C/4 or above (or equivalent) including maths and English
- Level 3 Engineering Apprenticeship certificate or will have a Level 3 Engineering Qualification (e.g. BTEC) plus 3 years’ experience (or equivalent)
Work-based and knowledge competencies to be delivered in line with the Level 4 Engineering Manufacturing Technician apprenticeship standard.
Training to be provided will be block release with Manufacturing Technology Centre. This will take place through a combination of:
- 1-to-1 tutorials
You will gain transferable core skills and knowledge, as well as skills specific to the working practices of Pfizer. The knowledge qualification will be a Higher National Certificate in Engineering. Training will be part of contracted hours making up the working week.