i-Pharm GxP
Specialist in US Contract and Project Delivery | Life Science GxP
A leading life sciences organization in Indiana is seeking an experienced Instrumentation and Controls Project Manager to support the delivery of complex GMP capital projects. This is a W2 contract role, initially 12 months, with extension subject to performance and project demand.
Responsibilities
Lead the planning, execution, and delivery of I&C scope across large scale life sciences capital projects.
Manage I&C activities through design, procurement, installation, commissioning, and handover within a GMP regulated environment.
Act as the primary interface between engineering, automation, validation, construction, and external vendors for all I&C related scope.
Oversee I&C contractors and system integrators to ensure schedule, cost, and quality targets are achieved.
Ensure compliance with GMP, GAMP 5, and internal engineering standards throughout the project lifecycle.
Support commissioning and qualification activities, including review and approval of I&C documentation and test protocols.
Identify project risks and implement mitigation strategies related to instrumentation, controls, and automation systems.
Provide regular progress updates to senior stakeholders and project leadership.
Experience Required
Proven experience as an I&C Project Manager delivering projects in the life sciences or pharmaceutical manufacturing sector.
Strong background in instrumentation, PLCs, DCS, and process control systems within GMP facilities.
Demonstrated experience managing vendors, system integrators, and multidisciplinary project teams.
Solid understanding of commissioning, qualification, and validation requirements for regulated manufacturing environments.
Experience supporting capital projects from concept through execution and handover.
Strong communication, stakeholder management, and problem solving skills.
Ability to work on site in Indiana for the duration of the contract.
Seniority Level
Mid‑Senior level
Employment Type
Contract
Job Function
Manufacturing and Quality Assurance
Industries
Pharmaceutical Manufacturing and Biotechnology Research
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Responsibilities
Lead the planning, execution, and delivery of I&C scope across large scale life sciences capital projects.
Manage I&C activities through design, procurement, installation, commissioning, and handover within a GMP regulated environment.
Act as the primary interface between engineering, automation, validation, construction, and external vendors for all I&C related scope.
Oversee I&C contractors and system integrators to ensure schedule, cost, and quality targets are achieved.
Ensure compliance with GMP, GAMP 5, and internal engineering standards throughout the project lifecycle.
Support commissioning and qualification activities, including review and approval of I&C documentation and test protocols.
Identify project risks and implement mitigation strategies related to instrumentation, controls, and automation systems.
Provide regular progress updates to senior stakeholders and project leadership.
Experience Required
Proven experience as an I&C Project Manager delivering projects in the life sciences or pharmaceutical manufacturing sector.
Strong background in instrumentation, PLCs, DCS, and process control systems within GMP facilities.
Demonstrated experience managing vendors, system integrators, and multidisciplinary project teams.
Solid understanding of commissioning, qualification, and validation requirements for regulated manufacturing environments.
Experience supporting capital projects from concept through execution and handover.
Strong communication, stakeholder management, and problem solving skills.
Ability to work on site in Indiana for the duration of the contract.
Seniority Level
Mid‑Senior level
Employment Type
Contract
Job Function
Manufacturing and Quality Assurance
Industries
Pharmaceutical Manufacturing and Biotechnology Research
#J-18808-Ljbffr