Operation Engineer (1 year contract) | BioPharma | West

GMP TECHNOLOGIES (S) PTE LTD; Singapore; On-site; SGD 60,000 - 80,000; Full time

Job summary

A leading biotech company in Singapore seeks a skilled validation engineer to develop and validate processes, ensuring compliance and efficiency in production. The ideal candidate has 3-5 years of experience in a regulated environment, strong knowledge of cleaning validation, and excellent technical writing skills. This is an outstanding opportunity to contribute to impactful projects.

Qualifications

• Min. 3-5 years of experience in a regulated manufacturing environment.
• Direct, hands-on experience in New Product Introduction or Process Validation.
• Familiarity with cGMP standards and compliance practices.

Responsibilities

• Develop and validate buffer and media preparation processes.
• Establish and execute equipment cleaning validation protocols.
• Support new assembly and manufacturing process introductions.
• Create validation protocols and reports in alignment with project requirements.
• Collaborate with production supervisors to monitor validation activities.
• Ensure timely completion and proper documentation.

Skills

New Product Introduction (NPI)

Process Validation

Cleaning Validation principles

Regulatory guidelines

Technical writing

Communication

Leadership abilities

Education

Bachelor's degree in Chemical Engineering or related

Job description

Jobscope:

• Develop and validate buffer and media preparation processes, ensuring smooth process transfer to production.
• Establish and execute equipment cleaning validation protocols to meet operational and quality standards.
• Support new assembly and manufacturing process introductions, ensuring readiness and compliance.
• Create validation protocols and reports in alignment with project requirements and timelines.
• Collaborate closely with production supervisors to plan, execute, and monitor validation activities.
• Ensure timely completion and proper documentation of protocols, reports, and related records.
• Contribute to continuous improvement in operations efficiency and process reliability.

Requirements:

• Bachelors degree in Chemical Engineering, Biomedical Engineering, Biotechnology, or a related field.
• Min. 3-5 years of experience in a regulated manufacturing environment (Biotech, Pharma, or Medical Device).
• Direct, hands-on experience in New Product Introduction (NPI) or Process Validation.
• Strong knowledge of Cleaning Validation principles and regulatory guidelines (e.g., residue limits, analytical testing).
• Familiarity with cGMP standards and compliance practices.
• Excellent technical writing skills for drafting validation protocols and reports.
• Strong communication, teamwork, and leadership abilities to guide cross-functional validation teams.

To apply, please visit www.gmprecruit.com

To learn more about this opportunity, please contact Fiona Koh; [e-mail]

We regret that only shortlisted candidates will be notified.

GMP Technologies (S) Pte Ltd | EA Licence: 11C3793 | EA Personnel: Fiona Koh| Registration No: R11092398

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e2i is the empowering network for workers and employers seeking employment and employability solutions. e2i serves as a bridge between workers and employers, connecting with workers to offer job security through job-matching, career guidance and skills upgrading services, and partnering employers to address their manpower needs through recruitment, training, and job redesign solutions. e2i is a tripartite initiative of the National Trades Union Congress set up to support nation-wide manpower and skills upgrading initiatives.

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