Process Validation Engineer - MSAT / Biopharma

Amaris Consulting; Singapore; On-site; SGD 80,000 - 120,000; Full time

Job summary

Amaris Consulting is seeking a professional to support technology transfer for drug substance manufacturing in Singapore. The ideal candidate will have strong experience in GMP manufacturing, tech transfer, and process validation.

Responsibilities include driving scale-up activities from lab to commercial production, collaborating with cross-functional teams, and ensuring compliance with GMP standards. Candidates should have a degree in engineering or life sciences and demonstrate strong problem-solving skills.

Qualifications

• Experience in commercial-scale GMP manufacturing (biologics drug substance).
• Strong background in tech transfer and process validation.
• Hands-on experience with chromatography and filtration processes.
• Strong understanding of both manufacturing and quality perspectives.
• Experience in lab-to-commercial scale-up.
• Fluent English; additional languages are a plus.

Responsibilities

• Support and execute technology transfer for drug substance manufacturing.
• Drive scale-up activities from lab to commercial production.
• Collaborate with cross-functional teams to ensure smooth implementation.
• Develop and optimize processes for routine operations.
• Provide technical guidance to site teams.
• Lead validation activities including cleaning and risk assessments.

Skills

Tech transfer

Process validation

Chromatography

Filtration processes

Problem-solving

Stakeholder collaboration

Education

Degree in engineering, life sciences, or related field

Job description

Responsibilities

• Support and execute technology transfer for drug substance manufacturing
• Drive scale‑up activities from lab to commercial production
• Collaborate with cross‑functional teams to ensure smooth implementation
• Develop and optimize processes including purification, homogenisation, and cleaning processes for routine operations
• Provide technical guidance to site teams
• Lead and support validation activities including cleaning validation, water mixing validation, and risk assessments (e.g. extractables & leachables – E&L)
• Ensure compliance with GMP and regulatory standards
• Prepare and review validation protocols, reports, and technical documentation
• Support integration of single‑use systems and new manufacturing equipment

About You

• Experience in commercial‑scale GMP manufacturing (biologics drug substance)
• Strong background in tech transfer and process validation
• Hands‑on experience with chromatography and filtration processes
• Strong understanding of both manufacturing and quality perspectives
• Experience in lab‑to‑commercial scale‑up
• Academic background: degree in engineering, life sciences, or related field
• Fluent English. Additional languages are a plus.
• You demonstrate strong problem‑solving and stakeholder collaboration skills

Amaris Consulting is proud to be an equal‑opportunity workplace. We are committed to promoting diversity within the workforce and creating an inclusive working environment. For this purpose, we welcome applications from all qualified candidates regardless of gender, sexual orientation, race, ethnicity, beliefs, age, marital status, disability, or other characteristics.