Manager, Capital Project Delivery

Business: Pharma Solutions
Department: Engineering
Location: Lexington

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, along with a direct report team consisting of 1 Project Coordinator and in close alignment the Global Engineering Project Team, will be responsible for planning and execution of capital project initiatives for Piramal’s Lexington, KY sterile injectable facility. The role will also have a technical understanding of chemistry, process engineering and equipment in a pharmaceutical chemical manufacturing facility.

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

To perform this position successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill and/or ability 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.

• 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.
  

Education/Experience

• 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.
Additional education and/or training in management is strongly preferred.

Job Competencies

• 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

Job Conditions

The physical demands and work environment described here are representative of those that must be met by a team member to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. If any accommodations are needed, requests should be made to our Human Resources department.

• Physical Demands :
  • Frequent lifting, bending, stooping, squatting, pushing and pulling can be expected.
  • Long periods of standing and walking can be expected in this position.
  • This position may require long periods of sitting, typing, computer entry or looking at a computer.
• Work Environment :
  • Piramal Pharma Solutions is engaged in the business of pharmaceutical research and contract pharmaceutical manufacturing. As such, all PPS staff work in or nearby either chemical/pharmaceutical research or chemical/pharmaceutical manufacturing equipment and processes.
  • Potential limited exposure to hazardous chemicals.
  Personal protective equipment including safety glasses, lab coats, gloves, specialized clothing including laboratory uniform and appropriate shoes may be required in areas associated with this position.
  

Equal Employment Opportunity

Piramal Pharma Solutions is proud to be an Equal Employment Opportunity and Affirmative Action employer. We do not discriminate based upon race, religion, color, national origin, gender (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, gender expression, age, status as a protected veteran, status as an individual with a disability, or other applicable legally protected characteristics.