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.
Role Description
The Reliability and Compliance Engineer is accountable for the overall Engineering and current Good Manufacturing Practice (cGMP) compliance requirements within the Pfizer Sandwich clinical scale manufacturing facilities and laboratories. The role provides the necessary leadership and governance to ensure all statutory and corporate engineering functions are fulfilled.
The successful candidate will work across 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, calibration and instrumentation discipline support and governance.
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 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.
Qualifications (Training, Education & Prior Experience)
Essential:
- 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
- Good understanding of Process. Electrical, Controls and Instrument disciplines
- Knowledge and experience of maintenance and reliability best practice
- Up to date knowledge and experience of EHS legislation
Desirable:
- Chartered Engineer
- Certified in Continuous Improvement and evidence of investigations and improvements implemented
- Subject Matter Expert for systems including critical utilities, FMS, BMS and production equipment