Operations Superintendent

Job Overview

Requirements

• Shall adhere to all applicable regulatory requirements, including FDA, EPA, OSHA, and related safety, health and environmental procedures, policies and practices.
• Consistent support and practice of all Piramal Pharma Solutions mission, vision, and values.
• Identify and protect the original technical information as part of the company property.
  

Key Responsibilities

• Has Direct reports: Manufacturing/Packaging Supervisors and Operators.
• Accountable of Supervisors and Operation Operators. This includes midyear reviews and performance appraisal.
• Direct oversight of the manufacturing and packaging process.
• Collaborate with cross-functional teams (supply chain, tech service, quality, operational excellence, etc.) to provide support, implement best practices, and drive continuous improvement culture.
• Build effective relationships, influence, and motivate operations units to ensure their wholehearted commitment to the achievement of “First Time Right” in the overall process.
• Identify training needs and organize training interventions (with the assistance of QA) to meet quality standards.
• Closely monitor the completion of operator training assessments.
• Responsible for closely monitoring the disciplinary program for operator errors and to promote proper coaching and counselling.
• Closely monitor overtime and manage resources accordingly.
• Identify opportunities for re-structuring the operations teams based on skills. Ensure right people are placed at the right job.
• Work closely with production trainer to communicate lessons learned, developing work instructions for critical systems and operations.
• Identify areas to improve safety, quality, delivery, and cost.
• Actively GEMBA to promote a quality culture and ensure current Good Manufacturing and Environmental, Health and Safety Practices are being adhered to. Drive safety and quality culture.
• Lead and write deviations/risk assessments/investigations, with the input from all key stakeholders by applying various root cause analysis tools (i.e., 5 Whys, Fishbone diagram, FMEA, HEAR, etc.) to resolve the problem, ensure successful and timely resolutions and prevent future recurrences.
• Along with the team member(s), formulate appropriate CAPAs as necessary in support of the deviations/risk assessments/investigations and work with the appropriate team members to drive these to a timely completion.
• Collaborate to write and revise any existing SOP’s, batch records, and/or cleaning records with minimal oversight in collaboration with operations and technology transfer.
• Provide training and process support to production areas, which includes training on operations of equipment and oversight of the key processing steps during the manufacturing process.
• Participate in safety and HAZOP reviews as needed for facilities and process.
• Assist in identifying trends that are associated with non-conformances and present preventive actions to proactively reduce the number of deviations/corrections in Operations.
• Participate in project scale-up as part of the transfer team for the scale-up.
• Report and drive key performance indicators: Safety (Loss time and Recordable incidents rate), Right First time and manufacturing milestone to meet customer OTIF
• Participate in the implementation of continuous improvement initiatives as they relate to operations and quality activities.
• Schedule, manage, troubleshoot, and supervise production per GMP requirements in the plant.
• Assist in scheduling WO, placing work orders, tracking WO, Co-ordination with external vendors for any work associated with equipment in collaboration with Facilities and Maintenance (FM).
• Assist in developing spares for all the manufacturing equipment as a part of business continuity plan in collaboration with FM.
• Actively inspect integrity of the equipment through routine monitoring and assigning area owners.
• Ensuring the site is audit ready by promoting housekeeping and performing routine audits.
• Assist in commissioning new facilities, including:
• Debugging facilities, equipment, and systems
• Supervising installations
• Troubleshooting
• Perform other related assignments and projects as required
  

Key Interactions

• Operators, Process Leads, Technology Transfer, Pilot Plant, Production and Quality Trainer and Production Supervisor, Operations director.
• Quality Control and Assurance, Warehouse, Engineering and Maintenance functions
• Site and Regional Leadership
• External vendors and consultants
  

Education/Experience

• Minimum Bachelor of Science degree or commiserate industry experience
• Minimum of 5 years’ experience in a leadership role in manufacturing. Knowledge of relevant GMP regulations and pharmaceutical guidance’s required to ensure site compliance.
  

Job Competencies

• Good knowledge of CGMP requirements and ICH guidelines
• Knowledge of pharmaceutical manufacturing equipment, technology, and systems
• Excellent organizational and planning skills
• Focus on execution
• High attention to detail
• Strong communication skills, written, verbal, and interpersonal
• Demonstrated experience in successfully leading and closing GMP risk assessments, investigations, and deviations
• Strong software application skills including word processing, Excel spreadsheets, PowerPoint presentations, and Smartsheets
  

Critical Attributes

• EHS and Quality Focus, RFT
• Passionately Reliable
• Rapid Responsiveness
• Innovative Efficiency
• Teamwork
• Detail Orientation
• Strategic planner
• Execution / Delivery oriented
  

• Job Identification 9159
• Job Category Manufacturing
• Posting Date 08/21/2025, 01:56 PM
• Job Schedule Full time
• Locations USA-650 Cathill Road, Sellersville, PA, 18960, US