At a Glance
- Tasks: Lead the configuration and validation of lab systems in a biotech environment.
- Company: Join a leading biotech client making waves in digital quality systems.
- Benefits: Enjoy a competitive daily rate and the chance to work on cutting-edge projects.
- Why this job: Be at the forefront of biotech innovation while collaborating with diverse teams.
- Qualifications: 8+ years in lab systems with strong compliance knowledge required.
- Other info: Contract role starting August/September, perfect for experienced professionals.
The predicted salary is between 60000 - 84000 £ per year.
We're hiring a Principal Software Development Engineer on behalf of a leading biotech client to oversee the configuration, validation, and lifecycle support of critical lab systems. This role combines software engineering expertise with architectural ownership across digital quality systems.
Key Responsibilities:
- Lead technical configuration and validation of laboratory and EHS systems in a GxP environment.
- Oversee authoring and review of system lifecycle documents including system configurations, SOPs, risk assessments, and test protocols.
- Act as a digital administrator and technical lead for lab systems, ensuring compliance and system performance.
- Collaborate with lab automation teams to integrate standalone systems with LIMS and SDMS platforms.
- Support system upgrades, enhancements, and end-user support within regulated frameworks.
Required Skills:
- 8+ years of experience supporting and maintaining lab systems in a regulated environment.
- Strong knowledge of system validation lifecycle documentation and compliance frameworks (GAMP, CSV, etc.).
- Experience integrating lab systems (LIMS, SDMS, ELN, LES) and supporting digital transformation projects.
- Ability to lead cross-functional collaboration between IT, validation, and business teams.
- Excellent written and verbal communication, with a compliance-first mindset.
Nice to Have:
- Experience with scripting or development within scientific systems.
- Exposure to lab automation technologies or system interfacing standards.
- Previous leadership or team management experience within digital quality domains.
Principal Software Development Engineer / Data Architect (Biotech) employer: Berkley Group
Contact Detail:
Berkley Group Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Principal Software Development Engineer / Data Architect (Biotech)
✨Tip Number 1
Familiarise yourself with the specific lab systems mentioned in the job description, such as LIMS and SDMS. Understanding their functionalities and how they integrate can give you an edge during discussions.
✨Tip Number 2
Network with professionals in the biotech field, especially those who have experience in GxP environments. Engaging in conversations can provide insights into the role and may even lead to referrals.
✨Tip Number 3
Stay updated on the latest trends and technologies in lab automation and digital transformation. Being knowledgeable about current advancements can demonstrate your commitment to the field during interviews.
✨Tip Number 4
Prepare to discuss your experience with system validation lifecycle documentation. Be ready to share specific examples of how you've ensured compliance and improved system performance in previous roles.
We think you need these skills to ace Principal Software Development Engineer / Data Architect (Biotech)
Some tips for your application 🫡
Tailor Your CV: Make sure your CV highlights relevant experience in software development and data architecture, particularly in biotech or regulated environments. Emphasise your knowledge of system validation and compliance frameworks.
Craft a Compelling Cover Letter: Write a cover letter that showcases your passion for the biotech industry and your specific skills related to lab systems. Mention any relevant projects you've led and how they align with the responsibilities of the role.
Highlight Technical Skills: In your application, clearly outline your technical skills, especially those related to lab systems integration (LIMS, SDMS, etc.) and any experience with scripting or development within scientific systems.
Showcase Leadership Experience: If you have previous leadership or team management experience, make sure to include it in your application. Highlight how you've successfully led cross-functional teams and contributed to digital transformation projects.
How to prepare for a job interview at Berkley Group
✨Showcase Your Technical Expertise
Be prepared to discuss your experience with lab systems and the specific technologies mentioned in the job description. Highlight your knowledge of GxP environments and system validation processes, as this will demonstrate your suitability for the role.
✨Prepare for Scenario-Based Questions
Expect questions that assess your problem-solving skills in real-world situations. Think of examples where you've led cross-functional teams or managed system upgrades, and be ready to explain your approach and the outcomes.
✨Emphasise Compliance and Documentation Skills
Since the role involves significant documentation work, be ready to discuss your experience with lifecycle documents like SOPs and risk assessments. Show that you understand the importance of compliance in a regulated environment.
✨Demonstrate Leadership and Collaboration
Talk about your previous leadership experiences and how you've successfully collaborated with different teams. This is crucial for the role, so provide examples that highlight your ability to lead and communicate effectively across departments.