Piramal Pharma Ltd · 1 month ago
Manager, Capital Project Delivery
Lexington, KY
Full-time
Onsite
Mid, Senior Level
5+ years expPiramal 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 sterile injectable facility, requiring a technical understanding of engineering in the pharmaceutical sector.
BiotechnologyConsumer GoodsHealth CareManufacturingPharmaceutical
Responsibilities
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
Qualification
Required
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
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 multiple internal and external stakeholders
Proven success developing and delivering project deliverables for large budget projects
Prior experience leading project teams. Able to demonstrate skill in managing/negotiating key vendor relationships
Previous experience with pharmaceutical processing and all relevant aspects of a facility, including infrastructure, processing equipment, and utilities
Demonstrated proficiency with current Microsoft Office suite especially Microsoft projects and ability to use/understand CAD software helpful
Excellent organizational and planning skills
Demonstrated people leadership and development skills
Strong written, verbal, and interpersonal communication skills
Strong time management skills, including adjustment of work schedule as needed in order to meet project deadlines and commitments
Project management skills for the implementation and management of engineering projects to deliver on time, on budget and meeting specifications, while collaborating with ongoing operations for successful project implementation
Financial acumen for budgeting purposes
Strong knowledge of applicable regulatory requirements, including cGMP, FDA, (MI) OSHA, and EPA
Familiarity with quality systems and experience in validation of equipment/facility validation (URS, F/SAT, DQ, IQ, OQ, PQ, etc.)
Operation Excellence tools – Lean and Six Sigma
Influencing and persuasion skills
Positive attitude with Good analytical skills
Proactivity and innovative out of box thinking is a must
People management and ability to get work done in high pressure situations
Preferred
Additional education and/or training in management is strongly preferred
Company
Piramal Pharma Ltd
Piramal Pharma Limited (PPL) offers a portfolio of differentiated products and services through its 17 global facilities, which include end-to-end development and manufacturing capabilities, and a distribution network in over 100 countries.
10001+ employees
Funding
Current Stage
Late StageRecent News
Business Standard India
2025-12-12
2025-12-12
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