- Singapore
ANTAES ASIA PTE. LTD. Hiring! Full Time Manufacturing Engineer (Deviations) in , Earn up to SGD 6,000 - Ricebowl
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Job Description:
Contribute to Life Science projects for Antaes Asia clients
Lead complex technical investigations into manufacturing deviations, non-conformances, and environmental excursions.
Utilize structured Root Cause Analysis (RCA) tools (e.g., Fishbone, 5 Whys, FMEA) to identify underlying triggers.
Author comprehensive investigation reports that withstand rigorous internal and external regulatory audits (FDA,EMA, etc.).
Perform impact assessments on product quality, safety, and efficacy.
Design and implement Corrective and Preventive Actions (CAPAs) to eliminate recurrence of deviations.
Monitor the effectiveness of implemented CAPAs through data-driven metrics.
Identify trends in manufacturing data to proactively suggest process improvements and "Right First Time" (RFT) initiatives.
Provide real-time engineering floor support to troubleshoot equipment malfunctions or process drift.
Collaborate with Quality Assurance (QA) and Production teams to ensure all activities align with Standard Operating Procedures (SOPs).
Participate in the drafting and revision of SOPs, Batch Records, and Validation protocols.
Contribute to the promotion of Antaes services on top of assistance provided to clients
Job Requirements:
Bachelor degree in Science, Chemical Engineering, Mechanical Engineering, Manufacturing Engineering, Biotechnology, or related Life Science
2 years’ experience in Engineering, pharmaceutical industry
Proven track record in managing the full lifecycle of a deviation
Deep understanding of 21 CFR Part 210/211 and Annex 11/15
Adherence to safety protocols and global regulatory compliance
Candidate must be highly motivated, be able to work independently as well as in a team and have good organizational and oral and written communication skills
Created in 2007 in Switzerland, Antaes is a consulting company, specialized in Information Systems and Organization.
Antaes is operating in Singapore since 2016 to initially accompany customers of the Financial Services industry. Our Financial Services team is a diverse consulting team, many recruited from the industry, combining in-depth knowledge of our clients’ businesses, technology, and consulting disciplines. We are providing our financial industry clients with Business Management & Information Systems services.
At Antaes Asia, we help our customers with:
Buidling on the same approach and thanks to expertise gained at the group level, Antaes Asia is now also active in other industries such as TelCo, Shipping, LifeSciences...
Contribute to Life Science projects for Antaes Asia clients
Lead complex technical investigations into manufacturing deviations, non-conformances, and environmental excursions.
Utilize structured Root Cause Analysis (RCA) tools (e.g., Fishbone, 5 Whys, FMEA) to identify underlying triggers.
Author comprehensive investigation reports that withstand rigorous internal and external regulatory audits (FDA,EMA, etc.).
Perform impact assessments on product quality, safety, and efficacy.
Design and implement Corrective and Preventive Actions (CAPAs) to eliminate recurrence of deviations.
Monitor the effectiveness of implemented CAPAs through data-driven metrics.
Identify trends in manufacturing data to proactively suggest process improvements and "Right First Time" (RFT) initiatives.
Provide real-time engineering floor support to troubleshoot equipment malfunctions or process drift.
Collaborate with Quality Assurance (QA) and Production teams to ensure all activities align with Standard Operating Procedures (SOPs).
Participate in the drafting and revision of SOPs, Batch Records, and Validation protocols.
Contribute to the promotion of Antaes services on top of assistance provided to clients
Job Requirements:
Bachelor degree in Science, Chemical Engineering, Mechanical Engineering, Manufacturing Engineering, Biotechnology, or related Life Science
2 years’ experience in Engineering, pharmaceutical industry
Proven track record in managing the full lifecycle of a deviation
Deep understanding of 21 CFR Part 210/211 and Annex 11/15
Adherence to safety protocols and global regulatory compliance
Candidate must be highly motivated, be able to work independently as well as in a team and have good organizational and oral and written communication skills
Created in 2007 in Switzerland, Antaes is a consulting company, specialized in Information Systems and Organization.
Antaes is operating in Singapore since 2016 to initially accompany customers of the Financial Services industry. Our Financial Services team is a diverse consulting team, many recruited from the industry, combining in-depth knowledge of our clients’ businesses, technology, and consulting disciplines. We are providing our financial industry clients with Business Management & Information Systems services.
At Antaes Asia, we help our customers with:
- Business and IT Model transformation
- Legal & compliance
- Enhancement of client experience
- IT engineering
Buidling on the same approach and thanks to expertise gained at the group level, Antaes Asia is now also active in other industries such as TelCo, Shipping, LifeSciences...
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