GMP Operational Readiness & Reliability Engineer

Arcadis; Boston (MA); On-site; USD 120,000 - 180,000; Full time

Job summary

Arcadis seeks an Operational Readiness professional with pharma/biotech GMP experience to support critical Technical Operations and readiness initiatives. You will lead change management, ensure 100% compliance, and collaborate with CQV, project engineering, and operations teams in a regulated environment.

The role focuses on change control, asset onboarding, CMMS data, KPI reporting, and driving reliability through calibration, monitoring, and analysis within the TOSC Department.

Qualifications

• Experience in pharmaceutical/biotech regulated GMP manufacturing.
• Strong change control and documentation practices.
• Experience supporting operational readiness, technical operations, reliability, maintenance, calibration, or asset management.
• Knowledge of CMMS, asset onboarding, asset hierarchy, and maintenance data management.
• Ability to read P&IDs, equipment drawings, and technical documentation.

Responsibilities

• Lead and support change management activities for operational readiness initiatives.
• Develop strategies to support adoption of project or initiative-driven changes.
• Support communication efforts by enabling design, development, delivery, and management of project communications.
• Develop and maintain metrics decks focused on KPIs tracked and shared with stakeholders.
• Promote 100% compliance within Change Control and GMP standards/site procedures.
• Own and manage major change controls for key projects, ensuring timely execution and closure.
• Support deviation and CAPA generation, investigation, and closure activities.
• Support technical operations duties and collaborate within the TOSC Department.
• Evaluate calibration requirements for new equipment in a regulated manufacturing environment.
• Collaborate with CMMS data specialists to onboard assets and build asset hierarchy.
• Advance Reliability Engineering initiatives, including vibration analysis and equipment monitoring.
• Walk down systems with CQV and project engineering to support readiness deliverables.
• Interpret P&IDs and drawings to support readiness and compliance.
• Identify equipment design improvements to reduce downtime and costs.
• Develop Reliability KPIs to improve performance visibility and decision-making.
• Generate and maintain Reliability reports and equipment performance metrics.
• Monitor equipment performance data to identify trends and potential failures.

Skills

Change management

Compliance

Communication

KPI reporting

Reliability engineering

CMMS

Cross-functional collaboration

Education

Bachelor's in Engineering/Life Sciences

Tools

CMMS software

Job description

Arcadis seeks an Operational Readiness professional with pharma/biotech GMP experience to support critical Technical Operations and readiness initiatives. You will lead change management, ensure 100% compliance, and collaborate with CQV, project engineering, and operations teams in a regulated environment.

The role focuses on change control, asset onboarding, CMMS data, KPI reporting, and driving reliability through calibration, monitoring, and analysis within the TOSC Department.