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Position: Equipment Technology Manager –Formulation

Location: Vizag, Andhra Pradesh, India

Job Description:

ROLE SUMMARY

  • Provide Formulation equipment engineering subject matter expertise for Pfizer’s state-of-the-art, large scale injectable facility located in Vizag, India
  • The Formulation equipment engineer is responsible for providing engineering technical and equipment qualification support to the operating unit ensuring that the equipment is running as intended and that all equipment issues are resolved to support the manufacture and timely disposition of the product
  • This role focuses on leading and resolving technical issues within the Operations Unit, implementation of CAPAs and equipment improvements, support generation of product impact assessments, providing routine technical support and troubleshooting, investigation closeout, and maintaining the qualification status of the physical plant and equipment.

  • The Formulation Equipment Engineer is responsible for Project Management/ execution of assigned projects (short duration), which includes the management of internal company resources (assets financial and personnel), external Engineering and vendors as part of the execution of projects. The direct management responsibility includes all support activities and functions necessary to ensure successful completion of project objectives
  • The Formulation Equipment Engineer is responsible for providing technical expertise during audits and also to present/ defend engineering systems, applicable change controls, investigations, and equipment qualification packages to the regulatory agencies if required.
  • Support development of a world-class sterile injectable manufacturing site at Vizag by providing Formulation Equipment Engineering and Technology expertise
  • The scope of equipment includes solution preparation, filtration, dispensing, Cleaning in place.

ROLE RESPONSIBILITIES

  • Ensure all equipment installed is safe, effective, and in compliance with industry standards.
  • Ensure all company and site engineering policies and procedures are adhered to.
  • Provide technical support in periodically reviewing Preventive/Predictive Maintenance programs, in collaboration with the maintenance manager, to improve the operational reliability of the equipment
  • Lead major investigations into equipment and/or process failures and implement equipment CAPA and performance improvements.
  • Review and approve documentation for cGMP validation, requalification, and periodic review of systems, equipment & manufacturing processes, including validation plans, risk assessments, protocols, and reports to maintain the equipment in a validated state.
  • Ensure all equipment installed is safe, effective, and in compliance with industry standards.

  • Ensure all company and site engineering policies and procedures are adhered to.
  • Provide technical support in periodically reviewing Preventive/Predictive Maintenance programs, in collaboration with the maintenance manager, to improve the operational reliability of the equipment
  • Lead major investigations into equipment and/or process failures and implement equipment CAPA and performance improvements.
  • Review and approve documentation for cGMP validation, requalification, and periodic review of systems, equipment & manufacturing processes, including validation plans, risk assessments, protocols, and reports to maintain the equipment in a validated state.
  • Write product/process impact assessments in support of investigation closures
  • Provide routine equipment technical support and troubleshooting for resolution of manufacturing issues
  • Work with the Maintenance and operation managers to develop competency improvement projects and tasks to up-skill the Manufacturing and Technician teams.

  • Support assessing training requirements of the Maintenance and Manufacturing operators and develop, in collaboration with the OEMs as required, appropriate, and tailored training plan. Provide technical training on process and equipment in collaboration with OEMs, as required.
  • Own the relationship with key vendors for the assigned equipment through this relationship speed up troubleshooting and fault finding responsiveness, improve equipment and spares availability through the equipment lifecycle
  • Own the equipment drawings, P&IDs and act as the primary link into the Automation team for the assigned equipment sets
  • Capacity and Reliability improvement projects delivered on time, within the cost, and meet the specifications/requirements of the Operating Unit.
  • Undertake continuous improvement projects to improve the performance or output of the assigned equipment: Identify equipment improvement and develop these into project scopes, this may also include progressing to funding approvals.
  • Work with the Reliability Engineer to get source data on equipment performance with a view to driving system improvements

  • Review all documents in relation to all improvements and upgrades.
  • Own and implement Change Controls and assigned CMTs
  • Provide technical expertise during audits and also to present/ defend engineering systems, applicable change controls, investigations, and equipment requalification packages to the regulatory agencies if required.
  • Lead/ represent Visual Inspection Equipment engineering on short-duration project teams where responsibilities would include SME technical oversight and the management and resolution of technical issues or changes arising throughout the project lifecycle whilst ensuring overall project objectives of scope, cost and schedule are adhered to.
  • Work to implement a culture of Right-First Time through partnerships with Operations and other Engineering functions
  • Support the design and selection of process & ancillary equipment

Desired Skills:

  • Knowledge and understanding of the US cGMP (21 CFR Parts 210, 211)
  • Understanding of the local safety and environmental regulations
  • Understanding of electronic batch records and electronic signatures (21CFR Part 11)
  • Ability to communicate with site & corporate global functions
  • Well versed with industry best practices and guidelines such as those with ISPE, PDA, ASME, etc.

PHYSICAL/MENTAL REQUIREMENTS

  • Ability to prioritize & manage a variety of activities at the same time
  • Good understanding of customer expectations and deliverables.

NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

  • Ability to visit the site during shifts, to provide technical help during any equipment emergency
  • Adhere to safe work practices, for example, cleanroom gowning.

ORGANIZATIONAL RELATIONSHIPS

  • Investigation & CAPA manager (tracks and manages the investigations, CAPAs; coordinate with other cross functions)

    Interactions with this position: (a) this position leads investigations within boundaries of responsibility i.e. TS Block, supports the Investigation lead for coordination with other cross functions

  • Automation & Instrumentation lead (owns administration of automation systems, and manage instrumentation SMEs)

    Interactions with this position: (a) this position manages the shift engineers who perform calibration, the shift engineers interact with SMEs (b) this position liaisons with automation & instrument SMEs for investigations & CAPAs identification

  • Plant Engineering lead (leads the maintenance and calibration of infrastructure inside TS Block, owns reliability program)

    Interactions with this position: (a) this position liaisons for complex troubleshooting, for thorough investigations and root-cause-analysis, CAPAs identification

  • Engineering PMO (program management for all engineering related activities)

    Interactions with this position: (a) this position liaisons with PMO to plan equipment downtime, shutdowns for facility & equipment maintenance, for implementation of capital projects and CAPAs

  • Capital Projects lead (manage the site capital program)

    Interactions with this position: (a) this position liaisons with capital projects lead for review of the maintenance and calibration requirements of new systems and equipment for capital projects

Responsible to coordinate with Global functions:

Equipment Engineering SMEs, Process Engineering SMEs, Automation SMEs.

RESOURCES MANAGED

Financial Accountability

Support generation of site capital budget by proposing appropriate technology solutions

Supervision

This position shall indirectly influence all decisions related to technology solutions and engineering technical topics.

As the team grows, junior engineers may be hired to report to this position.

Qualification: B.E/B.Tech (Mech/Chem/Elecr/Instrumentations) ,Advanced Degree Masters or Ph.D. Preferred, Knowledge of Equipment Qualification

Experience: 5-10 Years in Fill Finish (Injectables)

Salary: Negotiable

Contact Details:

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