Manager, Capital Project Delivery

Job Overview

Piramal Pharma Solutions, located in Lexington KY, is seeking a qualified Operation Delivery Head - Capital Projects. The Manager, Capital Project Operation Delivery, will develop a direct‑report team and work in close alignment with the Global Engineering Project Team. The position is responsible for planning and execution of operational initiatives that enable the successful execution of the capital expansion project for Piramal’s Lexington, KY sterile injectable facility.

The role requires a technical understanding of chemistry, process engineering and equipment in a pharmaceutical chemical manufacturing facility along with strong leadership skills.

Business:
Pharma Solutions

Department:
Engineering

Location:

Lexington

This position provides opportunities to work on a variety of challenging and rewarding projects with diverse technologies and job responsibilities. The successful candidate will lead commissioning and qualification of project roles, exercise and further develop well‑rounded skills in process and engineering project management, and interact directly with internal stakeholders and coordinate resources to execute technically complex projects, with broad responsibility for managing stakeholder relationships and project performance.

• A versatile and resourceful Mechanical/Electrical/Chemical Engineer/Pharmaceutical (or other applicable discipline) with project management skills and specialization in pharmaceutical formulations with added knowledge about formulation facilities.
• Adherence 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.
• Identification and protection of the original technical information as part of company property.

Reports To:

AVP and Site Head Lexington

• Capital Projects – New Facilities and Equipment
  • Specialization in filling and formulation process with detailed process understanding, process mapping, capacity calculations for complex sterile injectable facilities serving regulated markets.
  • Lexington site representative for approved $80M expansion project.
  • Work closely with Global Engineering team to coordinate shutdowns, raise and close change controls and other GMP documents.
  • Collaborate with cross‑functioning departments for document pre‑approvals, execution and post‑approvals required for qualification.
  • Support manufacturing activities for new equipment and facility expansions, including large‑scale expansion projects.
  • Assist in review and implementation of approved manufacturing procedures, batch records, and SOPs.
  • Support commissioning, start‑up and routine operation of manufacturing equipment, including: equipment and system troubleshooting; supervision/support of installation and start‑up activities; performance evaluation and optimization.
  • Participate in equipment qualification and validation activities: URS support, FAT/SAT participation; IQ, OQ, PQ execution support.
  • Collaborate with Engineering and Quality teams during technology transfer and process scale‑up activities.
  • Support development and implementation of new manufacturing technologies from concept to commercialization.
  • Coordinate with internal teams and external vendors to resolve manufacturing and equipment‑related issues.
  • Maintain accurate and compliant manufacturing documentation and logs.
  • Coordinate for new procedures and GMP documentation.
  • Commissioning new facilities, including IQ, OQ, PQ, debugging facilities, equipment and systems, supervising installations, troubleshooting, supervising initial start‑up, evaluating equipment performance, and supporting planning for additional staffing, training and onboarding.
  • Support development of new process technologies from concept to commercialization.
  • Teamwork skills and good communication skills.
  • Able to manage meetings, take ownership of tasks, communicate right information, and reach the right solution.
  • Good engineering skills with strong computer…