Senior Specialist, Equipment and Systems Team (12 months fixed term)

This is what you will do:

The Senior Specialist, Equipment and Systems primary focus will be supporting all QC Laboratory equipment and systems Activities.

This will include day to day routine maintenance and calibration activities for QC laboratory equipment, generation, and management of GMP documentation for all laboratory equipment which remain in a validated state in the cGMP Laboratories at ADMF/APICOM.

This individual will be a high functioning, highly adaptable resource for the QC Equipment and Systems team and will conduct activities in alignment with site SOPs and regulatory standards for laboratory equipment qualification and maintenance.

You will be responsible for:

• Daily instrument support
• Planning, executing, and documenting the PM/Cals on laboratory equipment released for use in a cGMP regulatory environment
• Accompanying vendors (as required) to ensure all documentation generated as part routine calibration/requalification is completed in a compliant manner
• Review and approval of PM/Cal validation documentation or reports
• Generation of tag numbers for equipment, introduction, and deactivation of work orders
• Conducting User access reviews on laboratory operating software
• Conducting Periodic review on laboratory operating software
• Ensure Audit readiness at all times
• Support any LEAN and CI lab activities and streamlining workshops
• Generation and resolution of protocol discrepancies, change controls and CAPAs as required.
• Generate SOPs as applicable.
• Ensure QAGs/SLAs are in place for all equipment vendors and contractors.
• Assist in additional duties as directed by the QC Equipment and Systems Manager.

You will need to have:

• Working knowledge QC Lab systems and equipment
• Working knowledge and understanding of current regulatory requirements for cGMP laboratory equipment
• The duties of this role are generally conducted in a lab environment. As is typical of a lab-based role, employees must be able, with or without an accommodation to: lift/carry 15/30 pounds unassisted/assisted; work comfortably in a controlled environment with and around biological, infectious, and hazardous materials; gown/degown PPE; use a computer; engage in communications via phone, video, and electronic messaging; engage in problem solving and non-linear thought, analysis, and dialogue; collaborate with others; maintain general availability during standard business hours.

We would prefer for you to have:

• A minimum of 3 years experience in a similar role
• A degree in chemistry, software, or an engineering related discipline
• Excellent technical competency in relation to instrumentation and equipment validation
• Skilled in organising, planning and priority setting along with strong time management skills
• Works very well in a collaborative manner
• Takes a structured, analytical approach to problem solving
• AI literacy to apply QC-relevant automation and analytics tools appropriately; data interpretation skills to translate AI-generated insights into scientifically sound outputs, and strong digital/compliant judgment to validate outputs, manage data integrity, and ensure GxP/quality requirements are met.

Our mission is to build an inclusive and equitable environment.

We want people to feel they belong at AstraZeneca and Alexion, starting with our recruitment process.

We welcome and consider applications from all qualified candidates, regardless of characteristics.

We offer reasonable adjustments/accommodations to help all candidates to perform at their best.

If you have a need for any adjustments/accommodations, please complete the section in the application form.