At a Glance
- Tasks: Support validation activities and ensure compliance with regulations at the Pirbright Site.
- Company: Join a leading pharmaceutical company focused on quality and innovation.
- Benefits: Competitive salary, career development opportunities, and a collaborative work environment.
- Other info: Dynamic role with opportunities for growth and learning in a regulated environment.
- Why this job: Make a real impact in the pharmaceutical industry while ensuring product quality and safety.
- Qualifications: Bachelor’s degree in relevant field and experience in Quality Assurance or Validation.
The predicted salary is between 40000 - 50000 € per year.
To support validation activities at the Pirbright Site, the Validation Execution Specialist will generate and/or revise validation documentation for utilities, facilities, processes, and equipment, ensuring delivery of commitments in line with timelines and internal/external validation regulations.
Tasks & Responsibilities
- Responsible for the successful delivery of the validation and qualification activities according to the Site Validation Master Plan (SVMP) for the Pirbright Site.
- Coordinate and support Validation activities for utilities and facilities revalidation (Water systems, Gases, HVAC, TCUs, SIP, Sterilisers, etc).
- Ensure HVAC validation activities are coordinated efficiently to maintain classified rooms/zones (A,B,C,D) in compliance and according to contamination control strategy of the site (from both physical and microbiological point of view).
- Manage external parties supporting validation activities.
- Review validation data packs, generate certificates, raise deviations, and support investigation, as required.
- Responsible for providing support for the successful delivery of the Validation activities for systems, processes and procedures.
- Support Process validation activities for new products by writing, reviewing or approving validation documents.
- Support Computerised systems and Spreadsheets validation.
- Support cross‑functional teams to establish protocols for miscellaneous validation activities such as Gowning qualification and disinfectant validation.
- Generation, review and/or approval of Validation documentation (Validation Plan, Protocols, Reports, Impact assessment, Risk assessment, URS, IQ, OQ, PQ, RA, Traceability Matrix, Periodic Reviews, etc) for the validation/qualification, when applicable.
- Ensure validation related activities are captured into change controls and new projects.
- Support change/project owners to identify validation needs.
- Act as a validation SME for new projects and change controls as appropriate.
- Support and provide guidance to validation contractors, end users, engineers in the delivery of validation documentation ensuring that a consistent and best‑practice approach is adopted with regards to generation of validation documentation.
- Review documentation such as SAT, FAT, Commissioning, Decommissioning Documents.
- Interpret and apply regulation/policies/corporate and local procedures during cross‑functional meetings building a culture of quality and validation compliance ensuring the fulfilment of the cGMP requirements.
- Guide and influence teams on GxP compliance.
- Support colleagues to resolve issues, risk assessment, periodic reviews, investigations, etc to support CAPA, change controls, deviations and other quality systems.
- Guide colleagues/QMS records owners to deliver compliant, regulatory‑acceptable records and documentation within the regulated areas.
- Act as the Validation member / validation SME of different forums such as Water committee, change control committee, QMR, etc.
- Actively support audit preparations and act as SME for validation, qualification, contamination control, classified room validation audit topics as needed.
Requirements
- Bachelor’s degree in Sciences, Engineering, Microbiology, or related field, or formal validation qualification.
- Significant experience in Quality Assurance/Manufacturing in a pharmaceutical company.
- Good knowledge & experience in Validation.
- Excellent knowledge of MS Office Suite.
- Excellent written and verbal communication skills; experience authoring technical documentation.
- In‑depth knowledge of the regulated pharmaceutical industry and compliance expectations (VMD, FDA, Eudralex Annex 1).
- Good understanding of industry guidelines (ISPE, PDA, ISO, HTM).
- Good understanding of GxP water systems, HVAC systems, pharmaceutical gases, etc.
- Experience in Biologicals beneficial.
- Experience in Sterile Manufacturing beneficial.
- Ability to work collaboratively across functions.
- A Disclosure and Barring Service (DBS) check will be required for the successful candidate.
- Any offer of employment will be subject to satisfactory DBS certificate.
Validation Execution Specialist employer: Boehringer Ingelheim
At the Pirbright Site, we pride ourselves on fostering a collaborative and innovative work culture that empowers our employees to excel in their roles. As a Validation Execution Specialist, you will benefit from comprehensive training and development opportunities, ensuring your professional growth while contributing to vital validation activities in a state-of-the-art facility. Our commitment to quality and compliance, combined with a supportive team environment, makes us an exceptional employer for those seeking meaningful and rewarding careers in the pharmaceutical industry.
StudySmarter Expert Advice🤫
We think this is how you could land Validation Execution Specialist
✨Tip Number 1
Network like a pro! Reach out to people in the industry, especially those who work at the Pirbright Site or similar companies. A friendly chat can open doors and give you insider info that could help you stand out.
✨Tip Number 2
Prepare for interviews by brushing up on your knowledge of validation processes and regulations. Be ready to discuss how your experience aligns with the role of Validation Execution Specialist. We want to see your passion for compliance and quality!
✨Tip Number 3
Showcase your skills! Bring examples of your previous validation documentation or projects to the interview. This will demonstrate your hands-on experience and understanding of the validation lifecycle, making you a strong candidate.
✨Tip Number 4
Don’t forget to apply through our website! It’s the best way to ensure your application gets noticed. Plus, we love seeing candidates who take the initiative to connect directly with us.
We think you need these skills to ace Validation Execution Specialist
Some tips for your application 🫡
Tailor Your Application:Make sure to customise your CV and cover letter for the Validation Execution Specialist role. Highlight your relevant experience in validation and quality assurance, and don’t forget to mention any specific projects that align with the job description.
Show Off Your Skills:We want to see your excellent written communication skills in action! When you write your application, use clear and concise language to demonstrate your ability to author technical documentation. This is key for the role!
Be Specific About Your Experience:When discussing your past roles, be specific about your experience with validation activities, especially in regulated environments. Mention any familiarity with GxP compliance and how you've contributed to maintaining quality standards.
Apply Through Our Website:Don’t forget to apply through our website! It’s the best way for us to receive your application and ensures you’re considered for the role. We can’t wait to see what you bring to the table!
How to prepare for a job interview at Boehringer Ingelheim
✨Know Your Validation Stuff
Make sure you brush up on your knowledge of validation processes, especially in the pharmaceutical industry. Familiarise yourself with terms like IQ, OQ, PQ, and GxP compliance. Being able to discuss these confidently will show that you're serious about the role.
✨Showcase Your Documentation Skills
Since the role involves generating and reviewing validation documentation, be prepared to talk about your experience with technical writing. Bring examples of documents you've authored or reviewed, and be ready to explain how you ensure compliance with regulations.
✨Collaboration is Key
This position requires working with cross-functional teams, so highlight your teamwork skills. Think of specific examples where you've successfully collaborated with others to achieve a common goal, especially in validation or quality assurance contexts.
✨Prepare for Scenario Questions
Expect questions that ask how you would handle specific validation challenges or compliance issues. Prepare by thinking through potential scenarios related to HVAC validation or change controls, and outline your approach to resolving them effectively.
