Validation Specialist

Validation Specialist

Maidstone Full-Time 36000 - 60000 £ / year (est.) No home office possible
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At a Glance

  • Tasks: Coordinate and execute validation of facilities, processes, and equipment in a dynamic pharma environment.
  • Company: Join a leading life science organisation making a real impact in the biopharma sector.
  • Benefits: Enjoy a permanent role with opportunities for professional growth and development.
  • Why this job: Be part of a critical team ensuring compliance and quality in life-saving products.
  • Qualifications: Degree in Chemistry, Biology, Engineering or related fields; knowledge of cGMP is essential.
  • Other info: Ideal for self-motivated individuals who thrive in fast-paced, responsible roles.

The predicted salary is between 36000 - 60000 £ per year.

Our client is a leading life science organisation. At present, they are seeking a Validation Specialist on a permanent basis at their site in the South East, UK.

Responsibilities:

  • To co-ordinate and execute the validation and re-qualification of facilities, processes, equipment, and Computer Systems (including cleaning validation) where required, to meet the site operations business needs.

Deliverables:

  • Ensure review and update of validation procedures (Policies, Master plans, SOP’s etc.) for equipment and facilities.
  • Establish and maintain Validation Plans as applicable.
  • Prepare, execute and report validation protocol including cleaning validation in accordance with EU GMP.
  • Perform qualification and requalification temperature mapping activities of storage locations, i.e. refrigerators, freezers and incubators.
  • Perform qualification studies on other equipment and processes.
  • Establish and maintain the re-qualification schedule for validated equipment.
  • Liaise with Engineering, Quality Assurance and User Departments to ensure that validation is conducted in a timely manner according to the Validation Plan and with minimal disruption to production.
  • Attend meetings, both internal and external, representing the department in a professional manner.
  • Participate in audits by customers and regulatory authorities.
  • Ensure that safe working methods and practices are adopted at all times and in accordance with Company policy for the safety of the postholder and others within the working environment.
  • Be responsible for housekeeping, tidiness and general cleanliness of all areas in which the post holder is working.

Education / Experience:

  • Degree level, preferably in Chemistry, Biology, Engineering or Related Subjects.
  • Knowledge of cGMP.
  • Understanding of ISO 9001 and ISO13485 Quality Systems.

Key Skills:

  • General understanding of IQ, OQ, PQ, PV.
  • Temperature mapping.
  • Cleaning Validation.
  • Data Integrity.
  • Water system validation.
  • HVAC system validation.
  • Ability to author and execute validation reports.
  • Ability to write validation related procedures.
  • Understanding of calibration principles.
  • Ability to challenge systems to ensure that they are slick and value adding as well as being compliant.
  • Use of Microsoft Word, PowerPoint and Excel.

It is important that the post holder is self-motivated and can manage multiple tasks. The role carries a high degree of responsibility and has a critical impact on the operation of cGMP related processes.

Training:

  • Understanding of ISO 9001 and ISO 13485 Quality System.
  • Knowledge of cGMP.

Validation Specialist employer: Adepto Technical Recruitment Ltd

As a leading life science organisation, our company offers Validation Specialists an exceptional work environment in the South East, UK, where innovation meets compliance. We pride ourselves on fostering a collaborative culture that prioritises employee growth through continuous training and development opportunities, ensuring that our team members are equipped to excel in their roles. With a commitment to safety and quality, we provide a supportive atmosphere that values each individual's contributions while maintaining high standards in the pharmaceutical industry.
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Contact Detail:

Adepto Technical Recruitment Ltd Recruiting Team

StudySmarter Expert Advice 🤫

We think this is how you could land Validation Specialist

✨Tip Number 1

Familiarise yourself with the latest EU GMP guidelines and ISO standards relevant to validation. This knowledge will not only help you in interviews but also demonstrate your commitment to staying updated in the field.

✨Tip Number 2

Network with professionals in the pharma and biopharma sectors. Attend industry conferences or webinars where you can meet potential colleagues and learn more about the specific challenges they face in validation roles.

✨Tip Number 3

Prepare to discuss specific examples of your experience with IQ, OQ, PQ, and PV during interviews. Having concrete instances ready will showcase your practical knowledge and problem-solving skills.

✨Tip Number 4

Demonstrate your ability to manage multiple tasks by sharing examples of how you've successfully prioritised and executed projects in previous roles. This will highlight your organisational skills, which are crucial for a Validation Specialist.

We think you need these skills to ace Validation Specialist

Validation Protocol Preparation
Cleaning Validation
Temperature Mapping
Qualification and Requalification Studies
Knowledge of cGMP
Understanding of ISO 9001 and ISO 13485
Data Integrity Management
Ability to Author Validation Reports
Procedure Writing Skills
Calibration Principles Understanding
Microsoft Word Proficiency
Microsoft PowerPoint Proficiency
Microsoft Excel Proficiency
Project Coordination
Attention to Detail
Self-Motivation
Multi-tasking Ability
Professional Communication Skills

Some tips for your application 🫡

Tailor Your CV: Make sure your CV highlights relevant experience and skills that align with the responsibilities of a Validation Specialist. Emphasise your knowledge of cGMP, ISO standards, and any specific validation processes you've worked on.

Craft a Strong Cover Letter: Write a cover letter that clearly outlines your motivation for applying to this role. Mention how your background in Chemistry, Biology, or Engineering makes you a suitable candidate, and provide examples of your experience with validation protocols.

Highlight Key Skills: In your application, specifically mention your abilities related to IQ, OQ, PQ, PV, and temperature mapping. Use bullet points to make these stand out, as they are crucial for the role.

Proofread Your Application: Before submitting, carefully proofread your CV and cover letter for any spelling or grammatical errors. A polished application reflects your attention to detail, which is essential for a Validation Specialist.

How to prepare for a job interview at Adepto Technical Recruitment Ltd

✨Know Your Validation Standards

Familiarise yourself with cGMP, ISO 9001, and ISO 13485 standards. Be prepared to discuss how these regulations impact validation processes and how you have applied them in previous roles.

✨Demonstrate Technical Knowledge

Be ready to explain the concepts of IQ, OQ, PQ, and PV. Provide examples of how you've executed validation protocols and handled temperature mapping activities in your past experiences.

✨Showcase Your Communication Skills

Since the role involves liaising with various departments, practice articulating your thoughts clearly. Prepare to discuss how you would represent the validation department in meetings and audits.

✨Highlight Your Problem-Solving Abilities

Think of instances where you challenged existing systems to improve efficiency while maintaining compliance. Be ready to share these examples to demonstrate your proactive approach to validation.

Validation Specialist
Adepto Technical Recruitment Ltd
Location: Maidstone
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