Manager, Capital Project Delivery

Job Overview

Piramal Pharma Solutions, located in Lexington KY, is seeking a qualified Delivery Head – Capital Projects to join our Engineering team. The Manager, Capital Project Delivery, will be responsible for planning and execution of capital project initiatives for Piramal’s Lexington, KY sterile injectable facility. The role will also require a technical understanding of chemistry, process engineering and equipment in a pharmaceutical chemical manufacturing facility.

Business:
Pharma Solutions
Department:
Engineering

Location:

Lexington

• A versatile and resourceful Mechanical/Electrical/Chemical Engineer (or other applicable discipline) with skills of project management and with Specialization in Pharmaceutical Formulations with added knowledge about formulation facilities.
• Shall adhere to all applicable regulatory requirements, including FDA, EPA, OSHA, and related safety, health and environmental procedures, policies and practices, including applicable HR policies.
• Consistent support and practice of all Piramal Pharma Solutions mission, vision, values, and success factors.
• Identify and protect the original technical information as part of the company property.

Reports To:

AVP And Site Head Lexington

• Capital Projects – New Facilities and Equipment
  • Specialization in filling and formulation process including detailed process understanding, process mapping, capacity calculations for complex sterile injectable facilities serving regulated markets.
  • Lexington Site Lead for approved $80M expansion project.
  • Detailed knowledge of high-end integrated projects of isolator-based injectable fill lines with the involvement of the lead equipment manufacturer.
  • Experience with the design and execution of complex injectable, highly potent process equipment, aseptic isolators, clean utilities, black utilities, water systems, HVAC and mechanical execution.
  • Define, evaluate, and prepare engineering standard, scope of work, materials and equipment used.
  • Review of the Process Flow Diagrams (PFD), Piping & Instrumentation Diagrams (P&IDs), Engineering drawings from the design engineering consultants.
  • Take part in Technical & Commercial Bidding Analysis (TBA/CBA) of key process equipment.
  • Project Management, Project budgeting and costing, execution of projects, management of key vendors.
  • Process Engineering, Process Design, Material & Energy Balances equipment Design.
  • Responsible for quality and workmanship of site project deliverables.
  • Verification of construction, technical specs along with review of vendor documents / drawings.
  • Commissioning new facilities, including:
    • IQ, OQ, PQ
    • Debugging facilities, equipment, and systems
    • Supervising installations
    • Troubleshooting
    • Supervising initial start-up
    • Evaluating equipment performance
    • Support planning for additional staffing, training and onboarding in the relevant project timeline.
  • Support development of new process technologies from concept to commercialization.
  • Teamwork skills & Good communication skills
  • Able to manage meetings, take ownership of task, communicate right information, reaching to right solution.
  • Good Engineering skills along with basic computer.
  • Risk‑taking and risk‑justification discussion capability and ready to learn new things by new challenges
• Existing Facilities and Equipment (Plants, Labs, Quality Control, and Safety)
  • Support meeting Key performance Indicators:
    Safety (Loss time and Recordable incidents rate), Right First time and project deliverables on time within budget
  • Promoting operational excellence culture and delivering operational excellence goals.
  • Recommend, justify, and manage processing equipment improvements or upgrades.
  • Troubleshoot facility and equipment problems and implement timely and cost‑effective solutions as needed.
  • Own and led deviation investigations as required.

• Bachelor’s degree in chemical, mechanical, or electrical engineering (or other applicable discipline) is required.
• Minimum five (5) years’ experience of GMP manufacturing and/or Process/Project management and/or pharmaceutical development experience.
• Prior experience and success managing complex projects with…