Operational Readiness 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 is seeking an Operational Readiness professional with pharmaceutical or biotechnology industry experience to support critical Technical Operations and operational readiness initiatives. This role will focus on change management, compliance, asset onboarding, reliability engineering, CMMS support, and cross-functional collaboration with CQV, project engineering, and technical operations teams in a regulated GMP environment.

• Apply a structured methodology to lead and support change management activities for operational readiness initiatives.
• Leverage change management processes, tools, and best practices to develop strategies that support adoption of project or initiative-driven changes.
• Support communication efforts by enabling the design, development, delivery, and management of key project and operational communications.
• Develop and maintain metrics decks focused on key performance indicators that are tracked, reviewed, and disseminated to stakeholders.
• Promote a culture of 100% compliance within the Change Control program and support adherence to GMP standards and site procedures.
• Own and manage major change controls for key critical projects, ensuring timely execution, documentation, and closure.
• Support deviation and CAPA generation, management, investigation support, and closure activities as needed.
• Support technical operations duties as assigned and work collaboratively as a team player within the TOSC Department.
• Evaluate calibration requirements for new equipment and instrumentation within a regulated pharmaceutical manufacturing environment.
• Collaborate with CMMS data specialists to ensure assets are accurately onboarded into CMMS and support the buildout of asset hierarchy.
• Help establish and build Reliability Engineering initiatives, including programs such as vibration analysis and equipment performance monitoring.
• Work closely with CQV and project engineering teams to walk down systems, review drawings, and support operational readiness deliverables.
• Interpret and apply system P&IDs, equipment drawings, and technical documentation to support readiness, reliability, and compliance activities.
• Identify equipment design improvements that minimize unplanned downtime and optimize cost effectiveness.
• Develop and advance Reliability Engineering KPIs to improve equipment reliability, performance visibility, and decision-making.
• Generate, manage, and maintain Reliability Engineering reports and equipment performance metrics.
• Monitor equipment performance data to identify trends, analyze potential failures, and support proactive reliability strategies.

Qualifications & Experience:

• Experience working in the pharmaceutical, biotechnology, life sciences, or other regulated GMP manufacturing environment.
• Strong understanding of change control, deviation, CAPA, compliance, and documentation practices within a regulated environment.
• Experience supporting operational readiness, technical operations, reliability engineering, maintenance, calibration, or asset management programs.
• Working knowledge of CMMS systems, asset onboarding, asset hierarchy, equipment records, and maintenance data management.
• Ability to read and interpret P&IDs, equipment drawings, system documentation, and technical engineering deliverables.
• Experience collaborating with CQV, project engineering, maintenance, manufacturing, quality, and technical operations stakeholders.
• Strong communication, organization, and stakeholder-management skills with the ability to support project communications and KPI reporting.
• Bachelor's Degree in Engineering, Life Sciences, or a related technical discipline preferred.
• Ability to provide legal US work authorization documents required. Will consider US domestic travelers and relocation.