Piramal Pharma Ltd · 1 month ago
Manager, Capital Project Operations Delivery
Lexington, KY
Full-time
Onsite
Senior Level
5+ years expPiramal Pharma Solutions is a pharmaceutical research and contract manufacturing company located in Lexington, KY. They are seeking a Manager for Capital Project Operations Delivery to oversee operational initiatives for capital expansion projects, ensuring successful execution and compliance with regulatory standards.
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 representative for approved $80M expansion project
Work closely with Global Engineering team to co-ordinate on shutdowns, raise Change controls, co-ordinate for closure of Change controls and other GMP documents
Collaborate with all cross-functioning departments for documents 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
Co-ordinate for new procedures, GMP documentations
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 strong computer abilities
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/Pharmaceutical (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
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
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
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
Company data provided by crunchbase