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Pharmaceutical Project Manager

Job in Indianapolis, Hamilton County, Indiana, 46262, USA
Listing for: YDU JC Air Cond & Ref Inc.- Dubai
Full Time position
Listed on 2026-08-05
Job specializations:
  • Business
    Regulatory Compliance Specialist
Salary/Wage Range or Industry Benchmark: 90500 - 135000 USD Yearly USD 90500.00 135000.00 YEAR
Job Description & How to Apply Below
Location: Indianapolis

Job Summary

This role is the day-to-day project lead for validated environment and laboratory construction projects (e.g., clean rooms, biosafety cabinets, containment suites, biocontainment labs, and related utilities) across a campus. The Project Manager reports to the Project Executive and partners with Engineering, QA/Validation, Delivery, Sponsors, and regional leadership to deliver projects within a validated-state framework, focusing on operational excellence, compliance, and both tactical and financial performance.

Responsibilities
  • Plan, execute, monitor, and close validated environment projects across multiple sites, ensuring IQ/OQ/PQ, equipment qualification, data integrity, and regulatory expectations are met.
  • Serve as the on-site/day-to-day project lead, coordinating owners, architects, engineers, QA/Validation, contractors, and vendors to achieve project objectives within validated-state constraints.
  • Collaborate with the Project Executive to define and maintain project scope, schedule, and budget baselines; monitor progress and report deviations.
  • Drive project schedule with a sense of urgency while not compromising quality.
  • Develop and implement validation strategies and documentation (validation plans, commissioning/qualification activities, and related records) aligned with corporate validation policy.
  • Identify, assess, and mitigate project-level risks that could impact deliverables, schedules, budgets, data integrity, or compliance; escalate as needed with proposed remedies.
  • Track and report project performance to the Project Executive, including schedule status, budget, risk, QA/validation progress, and regulatory readiness.
  • Manage and appropriately document change orders, project delays, procurement, and contract administration for assigned projects; ensure alignment with validated baselines and contract requirements.
  • Update all logs on at least a weekly basis.
  • Manage all documentation as per standards in Solution Navigator.
  • Ensure robust documentation controls that meet contract, QA, and regulatory standards (validation protocols, IQ/OQ/PQ records, SOP alignment, QA approvals) and support regulatory inspections.
  • Seek opportunities to improve validation workflows, data integrity practices, and delivery quality to enhance client satisfaction.
  • Maintain relationships with sponsors and stakeholders; act as a trusted advisor on validated-environment delivery and compliance at the project level.
  • Manage vendor and subcontractor performance for assigned projects, selecting qualified partners and ensuring alignment with timelines and objectives.
  • Manage project finances at the assignment level, including budgeting, forecasting, progress billings, and payables, ensuring alignment with project baselines.
  • Prepare the project team for regulatory inspections and audits through thorough documentation and traceability.
  • Foster a safe, compliant, and collaborative project environment; provide guidance to junior team members as needed.
Qualifications Required
  • Bachelor’s degree in construction, civil, mechanical, electrical engineering, construction management, business management, architecture, or a related field.
  • 5–10 years of direct project management experience on large capital projects, including regulated or validated settings (typical project sizes in the $5–$20M range; portfolio responsibility not required).
  • Demonstrated success delivering complex, multi-site projects in validated environments (GMP/GLP/ISO 17025) within labs, biopharma, pharmaceutical manufacturing, medical devices, healthcare, or related sectors.
  • Understanding of contract language, project accounting, and basic portfolio management as they apply to validated environments.
  • Strong executive communication skills; ability to present to senior leadership and diverse stakeholder groups; capable of influencing across functional boundaries.
  • Ability to lead and coordinate cross-functional teams (owners, architects, engineers, QA/Validation, contractors) in regulated contexts.
  • Proficiency with standard project management tools (Primavera P6, MS Project) and reporting platforms; advanced skills in MS Office with the ability to create executive-level…
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