Junior QC & Validation Engineer in St Helens

Sina Medical Glass, Ltd. is a UK-based start-up with an international team. Our mission is to ensure the production and ready supply of top-quality primary packaging (glass vials and cartridges) within the UK and internationally. We are building our quality management infrastructure from the ground up and are looking for driven individuals who want to grow with us and make a real impact in the pharmaceutical supply chain.

Role Overview

This is primarily a documentation and QMS role, with QC laboratory testing and validation support being equally important responsibilities. Your day-to-day focus will be writing and managing controlled documents such as SOPs, Work Instructions, forms, and quality records, supporting the build-out of our electronic QMS (eQMS), and performing hands-on physical and dimensional testing in the laboratory. When needed, you will also support equipment qualification and validation activities alongside the Deputy Quality Manager, helping to prepare and maintain validation protocols and reports. This role suits someone from a GMP-regulated background ideally within medical glass, pharmaceutical, or medical device industries who writes clearly, works methodically, and is ready to get stuck in at a start-up where the systems are still being built.

Key Responsibilities

• Technical Writing & Document Control — Primary Focus
  • Author, review, and maintain controlled documents including SOPs, Work Instructions (WIs), forms, templates, and quality records.
  • Support the build-out and day-to-day management of our eQMS, ensuring documents are structured, version-controlled, and audit-ready.
  • Ensure all documentation aligns with ISO 9001, ISO 15378, and GMP requirements.
  • Manage document lifecycle drafting, review cycles, approval, issuance, and archiving in line with document control procedures.
  • Support the development and rollout of training materials linked to new or revised documents.
• QC Laboratory & Product Testing – Primary Focus
  • Perform physical and dimensional testing on vials, cartridges, and glass tubing to defined specifications.
  • Conduct visual inspection of finished product in line with acceptance criteria.
  • Test to relevant standards including USP and applicable ASTM methods.
  • Record and trend test results and raise non-conformances where required.
  • Maintain lab equipment calibration records and testing logs.
• Validation & Equipment Qualification — Supporting Role
  • Assist in the preparation and formatting of IQ/OQ/PQ qualification protocols and summary reports under the direction of the Deputy Quality Manager.
  • Maintain and organise validation documentation within the eQMS.
  • Support scheduling and coordination of qualification activities with operations and equipment suppliers.
  • Help track open validation actions and ensure documentation is completed and closed in a timely manner.
• Quality Assurance Support
  • Assist with internal audit preparation, including document retrieval and evidence collation.
  • Support CAPA, non-conformance, and change control processes by maintaining records and tracking actions to closure.
  • Contribute to quality metrics and data trending reports.

Qualifications

• 2–3 years of experience in a Quality, documentation, or quality systems role within a GMP-regulated industry (medical glass, pharmaceutical, medical device, or primary packaging manufacturing preferred).
• Demonstrable technical writing skills; candidate must be able to independently produce clear, structured, audit-ready GMP documents (SOPs, WIs, forms, templates).
• Experience working within a document control system or eQMS platform.
• Working knowledge of ISO 9001 and GMP principles; familiarity with highly regulated manufacturing environments (e.g., ISO 15378, ISO 13485) is a bonus.
• Understanding of validation concepts (IQ/OQ/PQ/IOPQ/IOQ). Validation leadership experience is not required, but experience supporting validation process is necessary.
• Knowledge of USP and applicable ASTM standards.
• Degree (BSc or equivalent) in a relevant field: chemistry, pharmaceutical sciences, engineering, life sciences, or similar.
• Organised, detail-oriented, and comfortable building processes in an evolving environment.

Desirable Qualifications

• Direct experience in glass manufacturing or primary pharmaceutical packaging.
• Experience with eQMS administration (system setup, user management, workflow configuration).
• Experience supporting regulatory submissions or inspections.
• Familiarity with ISO 14971 (risk management).

This role reports to the Deputy Quality Manager.

Please submit your CV and a brief cover letter explaining your validation and technical writing experience. In your cover letter, please provide a brief example of a GMP document you have written from scratch (SOP, WI, or similar), describe any hands-on laboratory testing experience, and outline any exposure to validation or qualification activities.