Project Manager Indiana

About the role

The Project Manager (PM) is responsible for overall management of scope, schedule, and budget on CAPEX and cGMP-compliance projects to FDA & EU regulated Advanced Therapeutic industries. This role is responsible for planning and overseeing projects to ensure they are completed in a timely fashion and within budget, managing project delivery by closely aligning with client stakeholders and advocating for their project success.

Responsibilities

• Lead business process mapping sessions with site stakeholders to create roadmaps to CAPEX project solutions for personnel, equipment, facility, data, and quality.
• Manages Architect/Engineer, Design-Build, Design-Assist, General Contractor and Commissioning and Qualification teams throughout project execution.
• Directs construction administration processes with engineer of record including RFI’s, submittals, change orders, field observations, punch lists, turnover packages, and closeout documentation.
• Predicts, plans and resolves common design decisions that balance operational, quality, regulatory, schedule, budget, and constructability considerations.
• Responsible for overall scope, schedule, budget and risk management against contracts.
• Leads formal design review workshops at Conceptual, Basis of Design, 30%, 60%, 90%, IFC, and construction phases.
• Leads the process, tracking and controls for generation of project management documentation.
• Manages the successful execution of projects using cGMPnow standard tools and templates, client procedures and industry best practices to the agreed upon scope, schedule, budget and technical quality.
• Oversees design packages and specifications, RFPs, design review, vendor/contractor selection, constructability reviews, approval of submittals, and preparation and oversight of validation and regulatory submissions.
• Maintains project budgets and schedules for trends/compliance to budget and prepare periodic reports.
• Coordinates reviews and checking of engineering deliverables.
• Coordinates the efforts of engineering support groups and external resources such as vendors, consultants and contractors.
• Conducts project meetings with user group and project stakeholders.
• Prepares detailed project cost estimates and schedules.
• Supports project closeout activities including punch list management, turnover documentation review, as-built documentation verification, and lessons learned sessions.
• Supports the generation of draft proposals in response to client RFPs for PM review.
• Authors proposals for small to medium sized projects (<$1M).
• Leads team efforts to develop large proposals ($1M+).
• Verifies proposal alignment to cGMPnow Business Plan and brand.
• Documents status of proposals in the proprietary cGMPnow RFP Log system.
• Supports the generation of draft proposals in response to client RFPs for PM review.
• Authors proposals for small to medium sized projects (<$1M).
• Leads team efforts to develop large proposals ($1M+).
• Verifies proposal alignment to cGMPnow Business Plan and brand.
• Documents status of proposals in the proprietary cGMPnow RFP Log system.
• Supports the generation of draft proposals in response to client RFPs for PM review.
• Authors proposals for small to medium sized projects (<$1M).
• Leads team efforts to develop large proposals ($1M+).
• Verifies proposal alignment to cGMPnow Business Plan and brand.
• Documents status of proposals in the proprietary cGMPnow RFP Log system.
• Supports the generation of draft proposals in response to client RFPs for PM review.
• Authors proposals for small to medium sized projects (<$1M).
• Leads team efforts to develop large proposals ($1M+).
• Verifies proposal alignment to cGMPnow Business Plan and brand.
• Documents status of proposals in the proprietary cGMPnow RFP Log system.
• Supports the generation of draft proposals in response to client RFPs for PM review.
• Authors proposals for small to medium sized projects (<$1M).
• Leads team efforts to develop large proposals ($1M+).
• Verifies proposal alignment to cGMPnow Business Plan and brand.
• Documents status of proposals in the proprietary cGMPnow RFP Log system.
• Supports the generation of draft proposals in response to client RFPs for PM review.
• Authors proposals for small to medium sized projects (<$1M).
• Leads team efforts to develop large proposals ($1M+).
• Verifies proposal alignment to cGMPnow Business Plan and brand.
• Documents status of proposals in the proprietary cGMPnow RFP Log system.
• Supports the generation of draft proposals in response to client RFPs for PM review.
• Authors proposals for small to medium sized projects (<$1M).
• Leads team efforts to develop large proposals ($1M+).
• Verifies proposal alignment to cGMPnow Business Plan and brand.
• Documents status of proposals in the proprietary cGMPnow RFP Log system.
• Supports the generation of draft proposals in response to client RFPs for PM review.
• Authors proposals for small to medium sized projects (<$1M).
• Leads team efforts to develop large proposals ($1M+).
• Verifies proposal alignment to cGMPnow Business Plan and brand.
• Documents status of proposals in the proprietary cGMPnow RFP Log system.
• Supports the generation of draft proposals in response to client RFPs for PM review.
• Authors proposals for small to medium sized projects (<$1M).
• Leads team efforts to develop large proposals ($1M+).
• Verifies proposal alignment to cGMPnow Business Plan and brand.
• Documents status of proposals in the proprietary cGMPnow RFP Log system.
• Supports the generation of draft proposals in response to client RFPs for PM review.
• Authors proposals for small to medium sized projects (<$1M).
• Leads team efforts to develop large proposals ($1M+).
• Verifies proposal alignment to cGMPnow Business Plan and brand.
• Documents status of proposals in the proprietary cGMPnow RFP Log system.
• Supports the generation of draft proposals in response to client RFPs for PM review.
• Authors proposals for small to medium sized projects (<$1M).
• Leads team efforts to develop large proposals ($1M+).
• Verifies proposal alignment to cGMPnow Business Plan and brand.
• Documents status of proposals in the proprietary cGMPnow RFP Log system.
• Supports the generation of draft proposals in response to client RFPs for PM review.
• Authors proposals for small to medium sized projects (<$1M).
• Leads team efforts to develop large proposals ($1M+).
• Verifies proposal alignment to cGMPnow Business Plan and brand.
• Documents status of proposals in the proprietary cGMPnow RFP Log system.
• Supports the generation of draft proposals in response to client RFPs for PM review.
• Authors proposals for small to medium sized projects (<$1M).
• Leads team efforts to develop large proposals ($1M+).
• Verifies proposal alignment to cGMPnow Business Plan and brand.
• Documents status of proposals in the proprietary cGMPnow RFP Log system.
• Supports the generation of draft proposals in response to client RFPs for PM review.
• Authors proposals for small to medium sized projects (<$1M).
• Leads team efforts to develop large proposals ($1M+).
• Verifies proposal alignment to cGMPnow Business Plan and brand.
• Documents status of proposals in the proprietary cGMPnow RFP Log system.
• Supports the generation of draft proposals in response to client RFPs for PM review.
• Authors proposals for small to medium sized projects (<$1M).
• Leads team efforts to develop large proposals ($1M+).
• Verifies proposal alignment to cGMPnow Business Plan and brand.
• Documents status of proposals in the proprietary cGMPnow RFP Log system.
• Supports the generation of draft proposals in response to client RFPs for PM review.
• Authors proposals for small to medium sized projects (<$1M).
• Leads team efforts to develop large proposals ($1M+).
• Verifies proposal alignment to cGMPnow Business Plan and brand.
• Documents status of proposals in the proprietary cGMPnow RFP Log system.
• Supports the generation of draft proposals in response to client RFPs for PM review.
• Authors proposals for small to medium sized projects (<$1M).
• Leads team efforts to develop large proposals ($1M+).
• Verifies proposal alignment to cGMPnow Business Plan and brand.
• Documents status of proposals in the proprietary cGMPnow RFP Log system.
• Supports the generation of draft proposals in response to client RFPs for PM review.
• Authors proposals for small to medium sized projects (<$1M).
• Leads team efforts to develop large proposals ($1M+).
• Verifies proposal alignment to cGMPnow Business Plan and brand.
• Documents status of proposals in the proprietary cGMPnow RFP Log system.
• Supports the generation of draft proposals in response to client RFPs for PM review.
• Authors proposals for small to medium sized projects (<$1M).
• Leads team efforts to develop large proposals ($1M+).
• Verifies proposal alignment to cGMPnow Business Plan and brand.
• Documents status of proposals in the proprietary cGMPnow RFP Log system.
• Supports the generation of draft proposals in response to client RFPs for PM review.
• Authors proposals for small to medium sized projects (<$1M).
• Leads team efforts to develop large proposals ($1M+).
• Verifies proposal alignment to cGMPnow Business Plan and brand.
• Documents status of proposals in the proprietary cGMPnow RFP Log system.
• Supports the generation of draft proposals in response to client RFPs for PM review.
• Authors proposals for small to medium sized projects (<$1M).
• Leads team efforts to develop large proposals ($1M+).
• Verifies proposal alignment to cGMPnow Business Plan and brand.
• Documents status of proposals in the proprietary cGMPnow RFP Log system.
• Supports the generation of draft proposals in response to client RFPs for PM review.
• Authors proposals for small to medium sized projects (<$1M).
• Leads team efforts to develop large proposals ($1M+).
• Verifies proposal alignment to cGMPnow Business Plan and brand.
• Documents status of proposals in the proprietary cGMPnow RFP Log system.
• Supports the generation of draft proposals in response to client RFPs for PM review.
• Authors proposals for small to medium sized projects (<$1M).
• Leads team efforts to develop large proposals ($1M+).
• Verifies proposal alignment to cGMPnow Business Plan and brand.
• Documents status of proposals in the proprietary cGMPnow RFP Log system.
• Supports the generation of draft proposals in response to client RFPs for PM review.
• Authors proposals for small to medium sized projects (<$1M).
• Leads team efforts to develop large proposals ($1M+).
• Verifies proposal alignment to cGMPnow Business Plan and brand.
• Documents status of proposals in the proprietary cGMPnow RFP Log system.
• Supports the generation of draft proposals in response to client RFPs for PM review.
• Authors proposals for small to medium sized projects (<$1M).
• Leads team efforts to develop large proposals ($1M+).
• Verifies proposal alignment to cGMPnow Business Plan and brand.
• Documents status of proposals in the proprietary cGMPnow RFP Log system.
• Supports the generation of draft proposals in response to client RFPs for PM review