Validation Engineer (CQV, Temperature Mapping)

ALWAYSHIRED PTE. LTD.; Singapore; On-site; SGD 50,000 - 75,000; Full time

Job summary

A leading company in Singapore is seeking a professional for equipment qualification roles, responsible for preparing deliverables, monitoring vendors, and ensuring compliance with GxP requirements. A Bachelor’s degree in a related field and relevant experience is essential, while fresh graduates may be considered for junior roles. The ideal candidate should have knowledge of GMP environments and computerized system requirements.

Qualifications

• Minimum 2 years of relevant experience in pharma or medical devices.
• Fresh graduates with relevant internships may apply for Junior role.
• Understanding of computerized systems in compliance with 21 CFR Part 11.

Responsibilities

• Prepare equipment qualification deliverables including URS and risk assessments.
• Execute equipment qualification activities such as temperature mapping.
• Monitor and support equipment vendors during commissioning and qualification.

Skills

Temperature mapping

Data integrity assessments

Document control activities

Pharmaceutical industry regulations

GMP environment

Education

Bachelor’s degree in Life Sciences or Engineering

Tools

VLMS platforms (e.g., Kneat)

Laboratory and process equipment

Job description

Responsibilities

• Prepare equipment qualification deliverables including URS, risk assessments, data integrity assessments, specifications, CQ/IOQ protocols, and RTMs.
• Execute equipment qualification activities such as temperature mapping for controlled temperature units and IOQ for laboratory and process equipment.
• Monitor and support equipment vendors during commissioning, qualification, calibration, and maintenance activities.
• Author data integrity documentation, such as Data Integrity Assessments, EREST assessments, and audit trail reviews for computerized systems.
• Perform document control activities, including change control and management of qualification documents.
• Draft, revise, and review SOPs, forms, and operational or maintenance documentation in compliance with GxP requirements.

Requirements

• Bachelor’s degree in Life Sciences, Engineering, or related discipline.
• Minimum 2 years of relevant experience in pharmaceutical, medical device, or other regulated industries.
• Fresh graduates with relevant internships may be considered for a Junior role.
• Experience working with manufacturing or laboratory equipment in a GMP environment.
• Understanding of computerized system requirements in the pharmaceutical industry (e.g., 21 CFR Part 11, Annex 11).
• Preferably experienced in temperature mapping for controlled temperature systems (e.g., incubators, fridges, freezers, autoclaves, warehouses).
• Advantageous if familiar with lab and process equipment such as process tanks, FIT machines, ViCell, spectrophotometers, pH/conductivity meters, and osmometers.
• Experience with VLMS platforms such as Kneat is a strong plus.

Interested candidates please apply online or send your latest CV to [e-mail]

AlwaysHired Pte Ltd

Reg No: R1549345

EA: 24C2293

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