Senior Manager - Equipment Maintenance

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

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
• Coordination of Spare Parts management
• Supporting for the required reliability initiatives at Site

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

Cultural Attributes

• Conduct himself/herself in line with the Pfizer Values; Courage, Equity, Excellence & Joy

Statutory Obligations

• Conduct himself/herself in line with relevant legislation pertaining to workplace health and safety, discrimination, harassment and bullying.

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

Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.