About company
Life, it is the underlying purpose of everything we do at Pfizer. A purpose that defines our R & D strategy of discovering and developing innovative products that improve the quality of life. The worlds number one healthcare company, we have an annual turnover exceeding US $ 54 Billion and an annual global R & D spend of over US $ 7 Billion. Our key focus areas for growth include major therapeutic segments covering Cardiovascular, CNS, Oncology and Ophthalmology. We have a formula for success no other pharmaceutical company can duplicate our people, a team of professionals who take pride in their work and subscribe to our core values.
Job description
Equipment Maintenance:
- Ensure Equipment is maintained in good condition and minimize downtime.
- Coordinate with user to plan preventive maintenance and calibration program.
- To do health check of the maintenance & calibration program adhering CMMS program schedules
- Trending equipment failures / breakdowns and propose corrective actions.
- Carrying out modifications for improvement of the machine/ equipment performance
- Study & review operations, to contribute substantially for energy conversation & productivity improvements.
- To guide the team during breakdowns, trouble shooting and rectifying the basic causes in shortest possible time and also ensuring the data is captured in CMMS.
- To take all possible steps to ensure that all safety instructions and measures are strictly followed.
- Ensure all the team performing operation and maintenance of equipment / instrument are trained on relevant procedures.
- Ensure the activities being carried out in the Engineering are in line with the approved procedures.
- To coordinate with production for carrying out performance Verifications of various systems periodically.
- To ensure upkeep of plant & building w.r.t GMP standards & to carry out special tasks assigned from time to time.
- To study & review standby facilities for critical sub-assemblies and addition of capital equipment on long term basis for smooth operation
- Supporting for the required reliability initiatives at Site
- Manage multiple projects and ongoing work activities within the division typically involving cross-functional representatives.
- Lead and provide technical engineering oversight to develop project execution plans, and associated engineering studies for equipment component installation etc.
- Support programs and systems with procedures and training while ensuring compliance with all regulatory and company requirements.
- Ensure that all work is performed in accordance with Standard Operating Procedures (SOPs), Current Good Manufacturing Practices (cGMP), safety procedures, quality standards, Occupational Safety and Health Administration (OSHA) standards, other regulatory agency standards, and good maintenance practices.
- Develop and establish strategies and methods that improve preventive maintenance processes and procedures resulting in enhanced equipment performance.
- Perform equipment evaluations to determine and justify new equipment, equipment replacement and incorporate into capital plan.
- Facilitate and participate in equipment-based Root Cause Failure Analysis (RCFA) investigations.
- Provide governance of maintenance planning and scheduling across the Operating Units.
- Foster teamwork and encourage colleague development, provide salary planning recommendations as well as change management.
Equipment Qualification:
- Updating of drawings w.r.t changes in plant layout.
- Review new concepts, communicate with vendors for new requirements and preparation and review of URS for new equipment.
- Execute FAT activity applicable to the new equipment.
- Coordination of any additional activities with Cross functional teams on behalf of Engineering
- Ensure all the Engineering equipment/ Instruments / systems are qualified and maintained as per the Schedule of Calibration, Preventive Maintenance & Periodic Re-Qualification.
- Review and approve FAT, SAT, IQ, OQ, IOQ, PQ, PRQ & PV protocols.
- Review and approval of engineering drawings and layouts.
Project Management:
- Supporting for new/expansion/improvement projects
- To identify continuous improvement initiatives (process improvement, energy efficiency, etc.) and ensuring to implement them.
- Carrying out modifications for improvement of the machine/ equipment performance.
People Management:
- Engage and inspire the team on performance expectations and coach the team to meet those expectations using Coaching Skill principles.
- Focus on Safety and GMP Compliance as operational priorities and as performance measures that should be included in metrics.
- Know the processes and procedures, including the principles and practices of good data management (ALCOA), and be able to guide, advise and coach the team.
- Be accountable for the Good Data Management and Data integrity understanding and performance of the team.
- Effectively monitor the actions of the team. Ensure an active daily presence in the GMP work area to observe the work activity and practices.
- Note: any compliance deviations noted must be investigated in accordance with Site Standard Operating Procedures. Be available to the direct reports for real time escalations of any concerns or support needs.
- Be observant, investigate and report actions or behaviors that may negatively impact the desired outcome of the GMP process or activity.
- Lead and support continuous improvement efforts, where applicable.
- Be a role model to support a positive compliance culture.
- Review the content of all Leader Led Conversations and, on an annual basis, conduct two Leader Led Conversations with the teams aimed at fostering a culture that supports compliance with procedures, including good data management.
- Be vigilant for potential actions or behaviors that could result in breaches of GMP compliance or Data Integrity principles.
Reporting:
- To prepare monthly reports, annual expense statements etc.
- To prepare departmental budget and control the expenses within approved/ sanctioned limits.
- Prepare and review Management Information System (MIS) reports of the Engineering.
Documentation/Compliance:
- Change controls management.
- Support Investigations, identify root causes and suggest CAPAs.
- Develop procedures to comply with guidelines.
- Review and approval of respective documents.
- Implement cGMP and ensure compliance with laid down SOPs, Quality Systems, Safety Systems at all stages of activity.
- Extending required support during Walkthroughs, Internal Audits & Regulatory Audits
- Ensure all relevant Procedures like Standard Operating Procedures & Testing Procedures and other procedures are in place and being followed.
- Ensuring on time closure of change control and CAPA action items
- Drive Audit preparations readiness.
- Initiating and approving required purchase requisitions in Purchasing System
Staff Management:
- Reviewing performance of team members
- Ensuring development of team through Individual Development Plans (IDP)
- Guiding and coaching the team
Environmental Health and Safety:
- Participate in and take responsibility for workplace environment, health and safety at the level required for this position, following the guidelines in the company Environmental, Health and Safety Management System Manual.
- Ensuring that health and safety guidelines are followed.
- Conducting Safety Walkthroughs
Qualifications
Must-Have
- Graduate Engineer in Mechanical / Electronics and Instrumentation Engineering / Electrical and Electronics Engineering
- 15+ years of demonstrated experience.
- Knowledge of and ability to apply Process Safety Management elements.
- Knowledge of Enterprise Asset Management Solution or other CMMS applications required.
- Thorough knowledge and understanding of cGMP (current Good Manufacturing Practices), Food and Drug Administration, other regulations and current pharmaceutical industry standards.
- Strong people management experience, communication and leadership skills
- Ability to shift priorities according to changes in departmental/facility needs and be open to different ideas/approaches.
EducationUG: - B.Tech/B.E. in Mechanica