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- Tasks: Lead engineering maintenance and calibration processes in a dynamic pharmaceutical environment.
- Company: Join SERB Pharmaceuticals, a leader in cGMP compliance and innovation.
- Benefits: Competitive salary, comprehensive benefits, and a supportive team culture.
- Other info: Opportunity for career growth in a fast-paced, collaborative setting.
- Why this job: Make a real impact on quality and compliance in the pharmaceutical industry.
- Qualifications: Experience in GMP environments and strong data management skills required.
The predicted salary is between 60000 - 75000 ÂŁ per year.
This position will be responsible for configuring, delivering and validating efficient and effective maintenance and calibration processes at SERB in alignment with best practices in cGMP pharmaceuticals. As Engineering Maintenance Project Lead, your responsibilities will include implementing, validating, and embedding robust engineering maintenance and calibration processes and systems aligned with cGMP and industry best practices. The role acts as the bridge between Engineering, Quality, Production and Digital/IT, ensuring solutions are practical, compliant, and deliver measurable business value.
Key Accountabilities
- Engineering Maintenance & Calibration Data Transformation
- Lead the review, cleansing, enrichment, and standardisation of maintenance and calibration master data, including:
- Equipment and Instrument Master Data
- Functional Location hierarchies
- Task Lists, Maintenance Plans, and Calibration Strategies
- Bills of Material and Spare Parts
- Define and implement data governance principles, ownership, and quality rules to ensure data integrity is maintained post‑project.
- Prepare, validate, and execute data migration from legacy systems and spreadsheets into the target CMMS.
- Develop reconciliation and reporting mechanisms to assure data completeness and accuracy.
- Support the selection and implementation of a CMMS suitable for managing maintenance and calibration across SERB.
- Lead system configuration to align with defined best‑practice maintenance and calibration workflows.
- Own and deliver computer system validation activities, specifically critical User Acceptance Testing (UAT).
- Define and validate calibration workflows, certificates, tolerances, scheduling, escalation rules, and compliance controls.
- Act as business Subject Matter Expert, working closely with IT, system integrators, and vendors.
- Design and document end‑to‑end “To‑Be” maintenance and calibration processes, ensuring alignment with GMP expectations.
- Author or update SOPs, Work Instructions, and system user guides supporting maintenance planning, scheduling, calibration execution, data governance, change control, validation documentation, and governance forums.
- Define and implement maintenance and calibration KPIs, including schedule adherence, calibration compliance, preventive vs. corrective maintenance ratios, backlog health, work order quality, and data quality indicators.
- Use KPI insights to drive continuous improvement opportunities and corrective actions.
- Develop and deliver training materials and sessions for engineers, planners, technicians, and key users.
- Lead User Acceptance Testing (UAT) and business readiness activities.
- Drive change management, ensuring new processes and systems are understood, adopted, and embedded.
- Provide post‑go‑live stabilisation support and handover to BAU teams.
- Manage scope, timelines, risks, and dependencies across the maintenance and calibration workstream.
- Coordinate internal and external resources, including contractors, system integrators, and vendors.
- Provide regular progress updates, status reports, and risk escalations to stakeholders.
- Ensure alignment with SERB policies, Quality Systems, and global standards.
The above duties and responsibilities are not an exhaustive list, and you may be required to undertake any other reasonable duties compatible with your experience and competencies. This description may be varied from time to time to reflect changing business requirements.
To be successful in this role, you should demonstrate:
Essential
- Significant experience in engineering maintenance and calibration within GMP pharmaceutical or regulated manufacturing environments.
- Proven delivery of maintenance data cleansing, standardisation, and migration.
- Hands‑on experience with CMMS implementation and computer system validation (IQ/OQ/PQ/UAT).
- Strong understanding of maintenance planning, calibration compliance, and data governance.
- Ability to translate business needs into clear processes, data models, and system requirements.
- Excellent stakeholder management and communication skills.
Desirable
- Experience with SAP PM / S/4HANA, IBM MAXIMO or similar enterprise maintenance systems.
- Experience in implementing or managing calibration systems (e.g., cloud‑based CMS).
- Knowledge of GAMP, GMP Annex 11, and data integrity principles.
- Background in process transformation or continuous improvement.
- Experience defining and implementing maintenance KPIs and dashboards.
Personal Attributes
- Structured, detail‑oriented, and data‑driven.
- Able to work autonomously while influencing across functions.
- Pragmatic problem solver with a continuous improvement mindset.
- Comfortable operating in a fast‑paced, regulated project environment.
SERB Pharmaceuticals is an equal opportunity employer. We offer competitive compensation & benefit packages, challenging opportunities and a culture of working together in a supportive way built on our strong foundation of values.
Engineering Maintenance Project Lead employer: Thyroxine SERB
Contact Detail:
Thyroxine SERB Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Engineering Maintenance Project Lead
✨Tip Number 1
Network like a pro! Reach out to your connections in the industry, attend relevant events, and engage with professionals on platforms like LinkedIn. We all know that sometimes it’s not just what you know, but who you know that can help you land that dream job.
✨Tip Number 2
Prepare for interviews by researching the company and its culture. Understand their values and how they align with your own. We want you to walk into that interview feeling confident and ready to show them why you’re the perfect fit for the Engineering Maintenance Project Lead role.
✨Tip Number 3
Practice makes perfect! Conduct mock interviews with friends or mentors to refine your answers and get comfortable discussing your experience. We believe that the more you practice, the more natural it will feel when you’re in front of the real interview panel.
✨Tip Number 4
Don’t forget to follow up after your interviews! A simple thank-you email can go a long way in leaving a positive impression. We recommend expressing your appreciation for the opportunity and reiterating your enthusiasm for the role. It shows you’re genuinely interested!
We think you need these skills to ace Engineering Maintenance Project Lead
Some tips for your application 🫡
Tailor Your Application: Make sure to customise your CV and cover letter to highlight your experience in engineering maintenance and calibration, especially within GMP environments. We want to see how your skills align with the key accountabilities listed in the job description.
Showcase Your Achievements: Don’t just list your responsibilities; share specific examples of how you’ve successfully implemented maintenance processes or systems in the past. We love seeing measurable outcomes that demonstrate your impact!
Be Clear and Concise: Keep your application straightforward and to the point. Use clear language to describe your experiences and avoid jargon unless it’s relevant to the role. We appreciate clarity as much as you do!
Apply Through Our Website: We encourage you to submit your application directly through our website. It’s the best way for us to receive your details and ensures you’re considered for the role. Plus, it’s super easy!
How to prepare for a job interview at Thyroxine SERB
✨Know Your Data Inside Out
As an Engineering Maintenance Project Lead, you'll be dealing with a lot of data. Make sure you understand the key concepts around maintenance and calibration data transformation. Brush up on your experience with data cleansing, standardisation, and migration processes, as these will likely come up in your interview.
✨Familiarise Yourself with CMMS
Get to grips with Computerised Maintenance Management Systems (CMMS) before your interview. Be ready to discuss your hands-on experience with CMMS implementation and computer system validation. Highlight any specific systems you've worked with, like SAP PM or IBM MAXIMO, as this could set you apart from other candidates.
✨Showcase Your Stakeholder Management Skills
This role requires excellent communication and stakeholder management skills. Prepare examples of how you've successfully managed relationships across different functions in previous roles. Think about times when you had to influence others or coordinate with various teams to achieve a common goal.
✨Demonstrate Your Continuous Improvement Mindset
The company values a continuous improvement mindset, so be ready to share examples of how you've driven improvements in past projects. Discuss any KPIs you've defined and how you've used data insights to implement changes. This will show that you're not just about maintaining the status quo but are proactive in seeking better solutions.