Job Details
Job Description
Purpose of Job
As a Technical Services Engineer Apprentice, you will work within the Validation team as part of the Technical Services function to support GMP manufacturing activities and help maintain compliance with validation programmes.
This role is designed to provide structured training and hands-on experience in both equipment/system validation and process validation, supporting the lifecycle of validation activities in a regulated manufacturing environment.
Major Activities
- Support the execution of validation and qualification activities for equipment, systems, and manufacturing processes across Engineering, Manufacturing, and Quality Control departments.
- Support system owners in the development of User Requirement Specifications (URS) and Design Qualification (DQ) documentation, applying a risk-based approach where appropriate.
- Assist in the preparation, review, and execution of validation documentation, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) protocols, Validation and summary reports, Standard Operating Procedures (SOPs).
- Aid in reviewing externally generated validation documentation under supervision.
- Support process validation activities in line with regulatory expectations, including GMP and ICH Q8–Q12 guidelines.
- Work alongside Validation Specialists and Process Validation personnel to support Process validation activities, Technology transfer and New Product Introduction (NPI), as well as process improvements.
- Assist with deviation investigations, CAPAs, and change control activities related to validation work.
- Help maintain the validated state by supporting requalification and periodic review activities.
- Collaborate with cross-functional teams (Engineering, QA, QC, Manufacturing) to ensure timely completion of validation activities and documentation.
- Provide support during audits and inspections by preparing and organising validation documentation.
- Assist with Computer System Validation (CSV) and GAMP-related activities where required.
- Responsible for ensuring that own work complies with GMP, Data Integrity and Good Documentation Practice (GDP) and is undertaken in accordance with applicable procedures.
- Responsible for ensuring that own training is undertaken in a timely and GMP compliant manner before the task is undertaken.
- Responsible for ensuring that any GMP documentation e.g. (but not limited to) Issues, CAPAs, Change Controls, BMRs & audit/inspection actions, within own area of responsibility, is closed timely and in a Right First Time (RFT) state.
Qualifications and Skills
- Minimum of 5 GCSEs (or equivalent) including Maths, English, and a Science subject.
- A-levels (or equivalent) in a STEM-related subject. (e.g., Biology, Chemistry, Engineering, or Physics), or completion of a relevant Level 3 qualification (e.g., BTEC in Engineering or Applied Science)
- Eligibility to undertake the Science Industry Process Plant Engineer (SIPPE) Level 6 apprenticeship.
- An interest in or prior exposure to pharmaceutical, biotechnology, or regulated manufacturing environments would be desirable.
- Strong interest in engineering principles, manufacturing processes, and process optimisation.
- Ability to follow technical procedures accurately with a high level of attention to detail.
- Analytical thinking and problem-solving skills, with an interest in understanding how systems and processes operate.
- Good written and verbal communication skills, including the ability to document technical information clearly.
- Ability to plan, prioritise, and manage time effectively across multiple tasks.
- Proactive and willing to learn, with a commitment to continuous development.
- Basic IT skills (e.g., Microsoft Office) and ability to learn digital and data systems.
- Ability to work collaboratively within cross-functional teams. (Engineering, QA, QC, Manufacturing)
How to apply
To apply for this role and to find out more, please click on the apply button. Please note that applications may close before the application deadline, so apply early to avoid disappointment.
Job Details
About Advanced Therapies Apprenticeship Community (ATAC)
ATAC works with apprentices, employers and training providers to support industry-focused apprenticeships in advanced therapies, complex medicines and wider medicines manufacturing.
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About Advanced Therapies Apprenticeship Community (ATAC)
ATAC works with apprentices, employers and training providers to support industry-focused apprenticeships in advanced therapies, complex medicines and wider medicines manufacturing.
View Company Profile