Reliability & Compliance Engineer

Pfizer - Sandwich, Kent

Posted 766 days ago
  • Experience
    Not Applicable
  • Job function
    Manufacturing, Quality Assurance, Engineering
  • Employment type
    Full-time
  • Industry
    Pharmaceuticals
  • Employer job ID
    968852
  • Job ID
    3563432

This is a preview of the Reliability & Compliance Engineer job at Pfizer. To view the full job listing, join LinkedIn - its free!Join LinkedIn - its free!

About this job

Job description

Role Description

The Reliability and Compliance Engineer is accountable for the overall Engineering and GxP compliance requirements within the Pharmaceutical Sciences business units, and provides the necessary leadership and governance to ensure all statutory and corporate engineering functions are fulfilled.

 

The incumbent will work across all Pharm Sci areas including Active Pharmaceutical Ingredient Manufacture, Liquid Dose Manufacture (sterile), and Solid Dose Manufacture, and will provide the main customer interface between the engineering function and the customer to ensure all engineering and compliance requirements are dealt with effectively. Particular focus for this role will be electrical and/or instrumentation & calibration.

 

The Reliability and Compliance Engineer will also work closely with the internal Maintenance team to ensure an effective reliability strategy is developed that provides optimum equipment availability at minimum cost. The role will also involve effective liaison with external partner organisations, other Pfizer Pharm Sci sites, and other stakeholders as appropriate in order to optimise the overall engineering service provision to the business.

 

Other responsibilities within the role include financial management, people management, contractor management, management of minor capital projects, provision of overall quality oversight for the GPO operations, and facilitating a continuous improvement culture within the GPO organisation.

 

Responsibilities

 

Compliance:

Develop, implement and monitor the necessary systems and procedures to ensure compliance with all regulatory GxP, Calibration, and Statutory requirements.  The responsibilities within this will include:

• Develop, implement and monitor the relevant engineering standards and provide overall leadership and governance for the appropriate engineering discipline

• Ensure audit readiness for FDA/MHRA and other internal or external regulatory authorities, and represent the engineering and maintenance function to the auditors

• Ensure adherence to the change control process, raising appropriate change controls and driving to completion

• Lead quality low risk deviation investigations and calibration non conformances

• Identify and complete corrective and preventive actions

• Ensure compliance with engineering and maintenance training requirements

• Lead the instrument categorization assessment process and develop the necessary calibration schedules

• Approve calibration certificates

• Monitor and report calibration PM compliance and trends of deviations

• Ensure appropriate record retention

• Ensure compliance with all EHS statutory and internal requirements including pressure systems regulations, PUWER regulations, Lifting regulations etc

• Lead EHS incident investigations

 

Customer Service:

Provide the main communications interface between the customer and the Engineering, Maintenance, and laboratory support functions in order to align the engineering support with Pharm Sci priorities.  Responsibilities will include:

• Ensure short and long term maintenance strategy is development and implemented in line with Pharm Sci business objectives

• Hold regular meetings with the customer groups to build effective relationships, understand their business priorities and operational constraints

• Develop appropriate metrics to demonstrate engineering performance to the customer groups, and pursue a continuous improvement culture

• Interpret customer requirements and provide engineering solutions

• Liaise with other Pharm Sci operations and maintenance teams on other Pfizer sites to share best practice on reliability and compliance

• Ensure all engineering activities are undertaken in such a manner to minimize production down time

• Risk management of the engineering operation in relation to staff, skills, contract cover and spares

• Issue management of any major engineering issues related to the facility or services.

 

Maintenance Strategy:

Develop and implement the optimum reliability strategy to ensure maximum equipment availability at minimum cost, whilst also ensuring compliance with all GxP and EHS requirements.  Responsibilities will include:

• Discipline support and governance for electrical, controls and instrumentation systems

• Working closely with the maintenance team and customer representatives, implement the principles of the Pfizer Global Reliability Programme programme to develop optimum equipment reliability

• Carry out RCFA studies to address and resolve repeat failures

• Carry out PMO studies to define optimum maintenance strategy

• Provide engineering and maintenance expertise to troubleshoot complex engineering problems, and act as Subject Matter Expert in a variety of system/equipment types

• Together with the maintenance team, maximize the use of the Pfizer Computerised Maintenance Management System – EAMS - to provide meaningful data and metrics for monitoring and continuously improving engineering effectiveness and efficiency

• Work closely with FS and Procurement to ensure adherence to the asset lifecycle for new equipment purchases and installations in order to meet operational and maintenance/engineering requirements

• Support the development and implementation of high level plan for major shutdowns

 

Financial Management:

Work with the Maintenance Manager to develop and control the maintenance budget, and continuously seek to drive down the costs of delivery of engineering service.  Responsibilities will include:

• Monitor engineering costs at asset level, highlighting high spend areas.  Initiate improvement actions and projects to reduce overall costs

• Develop and implement the minor capex budget, with input from the maintenance team, customer groups, and Facilities Support

• Monitor and challenge where appropriate, the costs of key contractors and suppliers, and work with procurement to leverage high value items and services

• Provide regular reports on progress towards the operational budget, and support the maintenance team in delivering cost savings

 

People Management:

Lead and manage direct reports to provide an effective support function to the GPO organisation.  Liaise closely with the Maintenance Manager and Technicians to ensure optimum use of resources and engage with them to provide coaching and support.  Key responsibilities will include:

• Develop common objectives for the direct reports and maintenance team in line with Pharm Sci objectives

• Define the ongoing technical training requirements for the group, and ensure compliance with the relevant schedules

• Work closely with the Maintenance team to define and monitor training requirements and compliance

• Line management duties & responsibilities

 

Contractor Management:

Manage engineering contractors, suppliers, and service companies so as to ensure a cost effective and compliant service provision by GPO to Pharm Sci.  Responsibilities include:

• Work with Procurement to source the most cost effective suppliers

• Set the standards of service provision for key contractors and service agreements

• Monitor service levels and review contractor/supplier performance in terms of cost, effectiveness and compliance

• Carry out quality audits and competency assessments of key suppliers and contractors

• Manage key contractors and service providers on site to ensure compliance with all regulatory and EHS requirements

 

Project Management:

Work with the maintenance team and customer groups to identify, plan, and implement minor improvement projects.  For major projects, provide the necessary coordination between the project team and operations.  Responsibilities include:

• Provide the necessary justification and analysis in terms of cost, benefits, and risk for projects

• Source appropriate suppliers

• Ensure maintenance requirements are fully catered for including training, spare parts, documentation and PM schedules

• Manage the implementation of minor projects

• Support the validation of new projects from generation or URS through FAT to VSR completion

• Maintain up to date awareness of new technology, equipment and process development, and maintenance techniques and make recommendations for implementation of same

 

Quality Management:

Take overall responsibility for implementation of the relevant GPO Quality Management systems and procedures.  Specific responsibilities include:

• Arrange regular monitoring of adherence of GPO to the applicable GPO Quality Management System procedures and applicable customer Standard Operating Procedures and Standard Operating Instructions

• Oversee GPO’s processes for maintenance, storage and archiving of regulatory records both electronic and paper

• Represent GPO at the relevant site quality forums

 

Continuous Improvement:

Provide the necessary drive and leadership to implement a culture of continuous improvement within the GPO organisation by:

• Support the GPO Lead and Pharm Sci leadership in developing and implementing the overall engineering strategy in alignment with the operational and business strategies

• Provide the necessary training in CI tools and techniques

• Develop metrics in conjunction with customer groups which drive business performance improvement

• Lead and facilitate yellow belt and green belt projects

Desired Skills and Experience

• Significant  industry related experience in API, Solid Dosage or Sterile Manufacturing environments
• Degree qualified in relevant discipline
• Up to date knowledge of cGMP and GLP regulatory requirements
• Subject Matter Expert for systems including critical utilities, FMS, BMS and production equipment
• Continuous Improvement certified and evidence of investigations and improvements implemented
• Good understanding of Process. Mechanical, Electrical and Instrument disciplines
• Knowledge and experience of maintenance and reliability best practice
• Up to date knowledge and experience of EHS legislation

About this company

Pfizer

Pfizer Inc: Working together for a healthier world

 

Founded in 1849, Pfizer is the world's premier biopharmaceutical company taking new approaches to better health.  We discover, develop, manufacture and deliver quality, safe and effective prescription medicines to treat and help prevent disease for both people and animals.  We also partner with healthcare providers, governments and local communities around the world to expand access to our medicines and to provide better quality health care and health system support.  At Pfizer, colleagues in more than 90 countries work every day to help people stay happier and healthier longer and to reduce the human and economic burden of disease worldwide.

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