Employment type: Full time and onsite rolePosition OverviewThe QC Laboratory project portfolio is established to improve the reliability, compliance, safety, and operational
efficiency of pharmaceutical laboratory areas. The projects are focused on replacing obsolete laboratory
equipment, upgrading or replacing critical laboratory infrastructure, improving HVAC performance, supporting
laboratory gases and fume hood systems, enhancing monitoring capabilities, and implementing facility re-layout
improvements. These initiatives are intended to maintain laboratory readiness, reduce operational risk, support
regulatory compliance, and ensure that QC laboratory operations can continue supporting product testing, release, and
business supply continuity..
Key Responsibilities- Manage QC laboratory capital projects from concept through commissioning, start-up, qualification support,
turnover, and close-out. - Develop detailed project execution plans, schedules, cost estimates, and resource plans.
- Ensure project objectives are delivered on time, within scope, budget, and quality standards.
- Apply approved project management methodologies, phase-gate processes, and design standards.
- Define and control project scope, ensuring alignment with approved business cases.
- Track and control project budgets, commitments, forecasts, and expenditures.
- Monitor project schedules, identify critical path risks, and implement recovery plans as needed.
- Lead change control processes for scope, cost, and schedule variations.
- Lead the development of conceptual, preliminary, and detailed designs with A/E firms for laboratory equipment
replacement, infrastructure upgrades, HVAC, gases, fume hoods, monitoring systems, and laboratory re
layout improvements. - Coordinate Engineering, QC Laboratory Operations, Quality, EHS, BI Sourcing, Maintenance, construction,
commissioning, and qualification support activities. - Review and approve design deliverables, technical specifications, and construction plans.
- Ensure constructability, operability, and maintainability are incorporated into project designs.
- Support laboratory equipment selection, installation, commissioning, documentation, and turnover to QC
Laboratory Operations. - Support procurement activities including bid evaluations, contract awards, and execution strategies.
- Manage A/E firms, engineering consultants, contractors, and suppliers.
- Ensure contractors meet safety, quality, schedule, and contractual obligations.
- Review contractor progress, invoices, claims, and change orders.
- Enforce site safety standards and promote a strong safety culture throughout the project lifecycle.
- Ensure compliance with internal policies, regulatory requirements, and industry standards.
- Maintain accurate project documentation and audit readiness.
- Identify, assess, and mitigate project-level risks and dependencies.
- Proactively resolve technical, schedule, cost, and execution challenges.
- Escalate critical risks and issues to stakeholders with recommended mitigation actions.
- Communicate project status, milestones, risks, and decisions to Local Engineering leadership.
- Prepare and maintain project dashboards, KPIs, and progress reports.
- Coordinate with BIAH's PMO for project document development
Required Qualifications- BS in Engineering
- Minimum of ten years of experience managing laboratory pharmaceutical capital projects.
- Bilingual: English/Spanish
- Traveling 15% is required (Domestic and International)
- Professional Engineering license for PR - preferable.
