Manager, Capital Project Operations Delivery

Job Description

Business: Pharma Solutions
Department: Engineering
Location: Lexington

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 the Global Engineering Project Team. The position will be responsible for planning and execution of the operational initiatives which will enable successful execution of the capital expansion project 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 along with strong leadership skills.

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 commissioning and qualification of project roles with opportunities to exercise and further develop well-rounded skills in process and engineering project management. 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/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.

Reporting Structure

Reports To: AVP And Site Head Lexington

Key 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.

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

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 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.