Senior Specialist - Engineering (Documentation & Validation Execution)

PHARMAGEND GLOBAL MEDICAL SERVICES PTE. LTD.; Singapore; On-site; SGD 70,000 - 100,000; Full time

Job summary

PHARMAGEND GLOBAL MEDICAL SERVICES PTE. LTD. is seeking a qualified engineering professional in Singapore to develop and manage comprehensive documentation for site operations, including SOPs, quality standards, and qualification protocols.

The role requires familiarity with cGMP practices and regulatory expectations such as HSA and FDA. The ideal candidate will support engineering operations for manufacturing, utilities and facilities, coordinate project documentation, and handle ad-hoc tasks

Qualifications

• Good technical writing skills.
• Experience drafting SOPs, quality standards and qualification protocols (URS, DQ, IQ, OQ, PQ).
• Familiar with cGMP practices and regulatory requirements (e.g., HSA, FDA).

Responsibilities

• Develop and maintain engineering documentation for site, following QMS procedures.
• Support engineering operations for manufacturing, utilities and facilities projects (new and retrofit).
• Coordinate and manage project documentation.
• Assist with ad-hoc duties as assigned by supervisor.

Skills

Technical writing

Education

Engineering degree

Job description

Job Description

• Personnel shall have good technical writing skills.
• Personnel shall be responsible for the development of engineering documentation like SOPs, quality standards, qualification protocols (e.g. URS, DQ, IQ, OQ, PQ etc.) for site with following of site QMS procedures.
• Personnel shall be familiar with cGMP practices required for pharmaceutical manufacturing industries.
• Personnel shall be familiar with the regulatory requirements (e.g. HSA, FDA etc.)
• Personnel shall be able to develop good documents by following PharmaGend applicable guidelines & procedures.
• Personnel shall be responsible for supporting the engineering operation including site new and retrofit projects related to manufacturing, utilities & facilities.
• Personnel should have the ability to handle project documentation and coordination.
• To assist on any ah-hoc duties that been assigned / task by the immediate superior.

Qualification

• Degree in Engineering with a minimum of 5 years of relevant experience.