What are the responsibilities and job description for the Engineer II, QA position at Thermo Fisher Scientific?
Job Title: Quality Engineer II, Validation
Reports to: Quality Manager
Location: Chelmsford, MA
As part of the Thermo Fisher Scientific team, you'll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world's toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer!
How will you make an impact?
As a member of the validation team, you will be accountable for the validation & qualification of our process equipment, instrumentation and computer systems to ensure they meet our quality system requirements.
What will you do?
- Assess and define assigned validation projects.
- Writing, reviewing, and implementing project validation protocols for standard & customized systems.
- Raise discrepancies and closeout validation documentation.
- Prepare validation summary reports for completed protocols
- Conduct deviation investigations, such as validation failures, equipment and instrument investigations to identify & implement the appropriate corrective actions.
- Act as point of contact and resolve technical issues related to our validation documentation system.
- Support other activities within the Quality Management?System as required?
- Demonstrate and promote the company vision of the 4 I's: Integrity, Intensity, Innovation and involvement
How will you get here?
Education
- BS in engineering or another scientific field.
- Equivalent combinations of education, training, and relevant work experience may be considered
Experience
- 2 years of hands-on validation experience with the development and execution of FAT, SAT, and IQ/OQ protocols.
- Self-motivated and proactive with confirmed time-management skills
- Experience with DeltaV or similar automation system.
- Minimum of 2 years' experience in control systems testing, preferably within the biotech or pharmaceutical sector.
Knowledge, Skills, Abilities
- Good understanding of GAMP, cGMP, GDP, and regulatory requirements for automated systems.
- Computer Systems Validation
- 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
- Knowledge of Quality standards (e.g. ISO 13485) preferred
- Global Systems (e.g.Trackwise, AGILE, E1, SAP, Kneat) preferred
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 (https://jobs.thermofisher.com/global/en/5-reasons-to-work-at-thermo-fisher-scientific) . 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 complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory at Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.
Apply today! http://jobs.thermofisher.com
Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.
Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.
Reports to: Quality Manager
Location: Chelmsford, MA
As part of the Thermo Fisher Scientific team, you'll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world's toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer!
How will you make an impact?
As a member of the validation team, you will be accountable for the validation & qualification of our process equipment, instrumentation and computer systems to ensure they meet our quality system requirements.
What will you do?
- Assess and define assigned validation projects.
- Writing, reviewing, and implementing project validation protocols for standard & customized systems.
- Raise discrepancies and closeout validation documentation.
- Prepare validation summary reports for completed protocols
- Conduct deviation investigations, such as validation failures, equipment and instrument investigations to identify & implement the appropriate corrective actions.
- Act as point of contact and resolve technical issues related to our validation documentation system.
- Support other activities within the Quality Management?System as required?
- Demonstrate and promote the company vision of the 4 I's: Integrity, Intensity, Innovation and involvement
How will you get here?
Education
- BS in engineering or another scientific field.
- Equivalent combinations of education, training, and relevant work experience may be considered
Experience
- 2 years of hands-on validation experience with the development and execution of FAT, SAT, and IQ/OQ protocols.
- Self-motivated and proactive with confirmed time-management skills
- Experience with DeltaV or similar automation system.
- Minimum of 2 years' experience in control systems testing, preferably within the biotech or pharmaceutical sector.
Knowledge, Skills, Abilities
- Good understanding of GAMP, cGMP, GDP, and regulatory requirements for automated systems.
- Computer Systems Validation
- 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
- Knowledge of Quality standards (e.g. ISO 13485) preferred
- Global Systems (e.g.Trackwise, AGILE, E1, SAP, Kneat) preferred
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 (https://jobs.thermofisher.com/global/en/5-reasons-to-work-at-thermo-fisher-scientific) . 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 complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory at Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.
Apply today! http://jobs.thermofisher.com
Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.
Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.
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