Job Description

Role Summary

The SRV ER (Science Risk based Validation, Engineer Responsible) is a C&Q (Commissioning & Qualification) role with responsibility for life cycle qualification documentation. This specific role is for Process Equipment in a solid dosage environment. The SRV ER will work with the Equipment Project Lead to ensure the system is commissioned and qualified as expected.  The role is client-side, reporting to the SRV supervisor, and will be accountable for commissioning strategy, schedule, quality, safety, and compliance during the commissioning & qualification lifecycle of the project. Candidates must have minimum 5+ years’ experience in pharma commissioning, proven management of commissioning partners and contractors as well as strong understanding of science and risk-based verification of facilities, utilities and process equipment.

Key Responsibilities

• Develop and own the Commissioning, Qualification & Validation (CQV) activities associated with your project, aligned to project schedule and GMP requirements up to Performance Qualification of all systems and equipment. Act as Client C&Q Lead for the project. Throughout execution; coordinate all commissioning and qualification activities and act as single point of contact for CQV interfaces.
• Plan and lead execution of system commissioning and qualification of equipment in accordance with project schedule and phased release of areas.
• Oversee and coordinate Commissioning Partner and commissioning sub-contractors; manage performance against scope and programme. Commissioning partner responsible for commissioning of utility and facility systems.
• Interface with internal stakeholders including Quality, Manufacturing, Operational Readiness, Engineering, EHS, QC.
• Good knowledge of GMP, validation lifecycle, CSV (computer system validation) fundamentals, and regulatory expectations for qualification documentation
• Provide regular CQV status reporting (commissioning progress, qualification status, open actions, risks) to the Senior Project Manager.
• Own risk management for your project: identify, evaluate and mitigate risks; maintain and report risk registers.
• Collaboration during turnover activities and ensure successful system handover to CQV and Operations including documentation, training and punch list closure.
• Ensure best-practice quality management and documentation for GMP and GEP compliance(CTOP, VTOP, test packs, deviation reports).
• Manage resolution of CQV issues, deviations, and change controls

Essential Requirements

Experience and Education:

• Degree qualification in Engineering, Science, related discipline or relevant experience
• Relevant experience in pharmaceutical and GMP regulated manufacturing environments.

Knowledge:

• Minimum 5+ years’ GMP experience, with demonstrable experience.
• Proven track record of commissioning and qualification involving solid dosage process equipment installation.
• Experience planning and delivering complex commissioning and qualification of systems.
• Excellent stakeholder management and reporting skills; able to present to senior leadership and governance forums.

Desirable Criteria

Key Competencies

• Leadership of client teams
• Strong problem solving and decision-making under programme pressure.
• Strong advocate and understanding of health & safety
• Strong communication skills across various levels of the organisation
• Detailed understanding of commissioning and qualification and best practice.
• Strong documentation discipline and attention to detail; quality-focused.