Carry out data analysis of test results to determine process performance and ... Finite Element Analysis interpretation.
Job Description Job Title : Job Id : Target Openings : Locations :
Mechanical Engineer - Industrialisation/Manufacture - Cambridge 1009571 1 United Kingdom-Cambridge
Organizational Marketing Statement 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 people. 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. Right now, we are seeking highly qualified candidates to fill the position: Mechanical Engineer - Industrialisation/Manufacture - Cambridge Job Focus 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 people. 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. Right now, we are seeking highly qualified candidates to fill the position: Mechanical Engineer - Industrialisation/Manufacture - Cambridge Capable mechanical engineer required to provide manufacturing support in the medical sector. Working as part of the team managing the development of drug delivery devices, the role focusses on manufacturing, assembly and test equipment. In addition it includes tasks from all stages of device development from Design for Manufacture through to validation. The role requires a combination of planning and assessment skills to predict (and mitigate) potential problems in the long-term, and trouble-shooting to investigate and resolve short-term issues. This is what you can look forward to: • Support the design and development of manufacturing processes for drug delivery devices assembly, labelling and packaging - within timelines and budgets
• Produce and approve requirement specifications for external suppliers (UK and abroad) • Analyse supplier equipment designs • Assess Design for Manufacture and Design for Assembly with internal and external design teams • Risk management assessment and mitigation, including creation of pFMEA. • Support supplier design reviews • Carry out data analysis of test results to determine process performance and acceptability • Carry out root cause analysis of manufacturing issues • Support Factory and Site Acceptance testing, including drafting or reviewing validation plans and testing protocols and setting or approving acceptance criteria. • Support capital equipment acquisitions ranging from bench top to fully automated commercial scale machines • Oversee Qualification activities for device related processes in Pfizer manufacturing group What you offer: Essential • Machine automation and automated assembly • Equipment Design Review and Validation • Testing and acceptance criteria • Risk Management • Task Management • Writing clear reports, documents and presentations • Understanding of quality management systems including GAMP • Tolerance Analysis • Structural Analysis • Finite Element Analysis interpretation Desirable • Process Capability Analysis (predictive and actual) • Knowledge of Fatigue Analysis • Knowledge of Material Selection and Compatibility • In Process Checks: sensor selection and signal processing • Knowledge of CFR21 Part 11 Machine Data Handling • Injection moulding Education and Experience • Degree or higher in Mechanical Engineering or equivalent • strong industrial experience in industrialisation /manufacturing, preferably within the medical industry. Experience of medical device assembly would be a benefit Person • Practical, analytical, pragmatic
• Capable of both working in a team and leading own independent work through to a conclusion • Communicates well with internal and external team members. Articulates ideas and concepts clearly to all levels and technical abilities • Able to learn and understand new concepts quickly • Capable of seeing the wider implications of technical decisions Location: Cambridge Equal Employment Opportunity Pfizer's aim is to provide equality of opportunity in the recruitment process by avoiding discrimination on the grounds of: age, disability, gender reassignment, race, religion or belief, sex, sexual orientation, marriage & civil partnership, pregnancy & maternity, political persuasion or trade union membership. At Pfizer we are creating an organisation and promoting a culture that respects each individual's unique character and life experiences, and reflects the diversity of our customers and markets. We will achieve this through fostering and sustaining an environment in which every colleague feels valued and supported, thus enabling superior business results. In addition to competitive salaries and customized benefits packages, we offer a supportive and diverse culture and unparalleled career development opportunities. Closing date: 17/03/2015 To apply please visit www.pfizercareers.com and search for JobID: 1009571 Role Description Capable mechanical engineer required to provide manufacturing support in the medical sector. Working as part of the team managing the development of drug delivery devices, the role focusses on manufacturing, assembly and test equipment. In addition it includes tasks from all stages of device development from Design for Manufacture through to validation. The role requires a combination of planning and assessment skills to predict (and mitigate) potential problems in the long-term, and trouble-shooting to investigate and resolve short-term issues. Responsibilities This is what you can look forward to: • Support the design and development of manufacturing processes for drug delivery devices assembly, labelling and packaging - within timelines and budgets • Produce and approve requirement specifications for external suppliers (UK and abroad) • Analyse supplier equipment designs • Assess Design for Manufacture and Design for Assembly with internal and external design teams • Risk management assessment and mitigation, including creation of pFMEA.
• Support supplier design reviews • Carry out data analysis of test results to determine process performance and acceptability • Carry out root cause analysis of manufacturing issues • Support Factory and Site Acceptance testing, including drafting or reviewing validation plans and testing protocols and setting or approving acceptance criteria. • Support capital equipment acquisitions ranging from bench top to fully automated commercial scale machines • Oversee Qualification activities for device related processes in Pfizer manufacturing group Qualifications What you offer: Essential • Machine automation and automated assembly • Equipment Design Review and Validation • Testing and acceptance criteria • Risk Management • Task Management • Writing clear reports, documents and presentations • Understanding of quality management systems including GAMP • Tolerance Analysis • Structural Analysis • Finite Element Analysis interpretation Desirable • Process Capability Analysis (predictive and actual) • Knowledge of Fatigue Analysis • Knowledge of Material Selection and Compatibility • In Process Checks: sensor selection and signal processing • Knowledge of CFR21 Part 11 Machine Data Handling • Injection moulding Education and Experience • Degree or higher in Mechanical Engineering or equivalent • At least 5 years industrial experience in industrialisation /manufacturing, preferably within the medical industry. Experience of medical device assembly would be a benefit Person • Practical, analytical, pragmatic • Capable of both working in a team and leading own independent work through to a conclusion • Communicates well with internal and external team members. Articulates ideas and concepts clearly to all levels and technical abilities
• Able to learn and understand new concepts quickly • Capable of seeing the wider implications of technical decisions Location: Cambridge
