Process Engineer (Manufacturing)

Job Summary

You will join the Manufacturing Engineering team where you will responsible for the qualification and improvement activities of BPC (Bio Product Chambers) manufacturing equipment and processes in support of the BPC production teams.

What will you do?

• Use engineering tools and methods such as DOE, FMEA, SPC and statistical analysis.
• Technical writing including engineering protocols and reports for standard and customised systems (URS, FAT, IQ, OQ, PV).
• Development and implementation of procedures to cGMP Standards (FCD, WID, SOP).
• Develop, lead and implement engineering projects to achieve performance metrics, budgets and timelines.
• Lead and/or assist in the specification, design, fabrication and qualification of manufacturing equipment to improve processes.
• Conduct investigations into validation/process failures & complaints in order to identify & implement the appropriate corrective actions using Trackwise Quality Management System.
• Tackle technical issues and implement corrective actions.
• Visit sister sites globally to learn/share standard methodology - less than 5% of year travel.

How will you get here?

Education:

• Mechanical/Process/Manufacturing Engineering Degree or equivalent experience in engineering or another scientific field.

Experience:

• Previous hands-on validation experience with the development and execution of FAT, SAT, and IQ/OQ protocols.
• Prior experience within the Pharmaceutical industry is an advantage.
• Experience working within a regulated industry/environment is essential.
• Leading/assisting qualification project executions and close out.
• Self-motivated, proactive, and capable of adhering to project timelines
• Writing, reviewing, and implementing of project URS, FAT, IQ/OQ, DoE & PV protocols.

Knowledge, Skills, Abilities:

• Proficient in Solidworks or AutoCAD is essential.
• Attention to detail and ability to identify and remediate issues found during testing.
• Highly effective verbal and written skills, including technical authorship.
• Proficient in Microsoft Office, particularly Microsoft Word and Excel
• Understanding of cGMP for all paperwork required.

Benefits we offer:

In addition to a competitive base salary and holiday package you will be eligible for an annual bonus, Private Health Insurance, Life Insurance, Pension Plan, as well as tailored benefits to suit your needs through our Flexible Benefits Package.

About us

When you’re part of Thermo Fisher Scientific, you’ll do challenging work, and join a team that values performance, quality and innovation. As part of a successful, growing global organization you will be encouraged to perform at your best. With revenues of more than $40 billion and the largest investment in R&D in the industry, we give our people the resources and chances to create significant contributions to the world.

Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve sophisticated scientific challenges, drive technological innovation and support patients in need. #StartYourStory at Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, colour, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.