Senior Specialist – Engineering (Documentation & Validation Execution)

PHARMAGEND GLOBAL MEDICAL SERVICES PTE. LTD.; Singapore; On-site; SGD 60,000 - 90,000; Full time

Job summary

PHARMAGEND GLOBAL MEDICAL SERVICES PTE. LTD.

is seeking a qualified documentation specialist to develop and maintain engineering documentation, SOPs, quality standards, and qualification protocols in line with site QMS procedures. The role requires familiarity with cGMP practices for pharmaceutical manufacturing, knowledge of regulatory requirements (HSA, FDA, etc.), and ability to coordinate project documentation for manufacturing, utilities and facilities, while supporting ad-hoc tasks from

Qualifications

• Degree in engineering and minimum of 5 years relevant experience.
• Strong ability to develop and maintain engineering documentation.
• Familiarity with cGMP practices in pharmaceutical manufacturing.

Responsibilities

• Develop SOPs, quality standards and qualification protocols (URS, DQ, IQ, OQ, PQ).
• Follow site QMS procedures to ensure compliant documentation.
• Support engineering operations for site projects (manufacturing, utilities & facilities).
• Coordinate project documentation and handle ad-hoc tasks from supervisor.

Skills

Technical writing

Document control

Education

Engineering degree

Job description

Job Description

1. Personnel shall have good technical writing skills.


2. 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.


3. Personnel shall be familiar with cGMP practices required for pharmaceutical manufacturing industries.


4. Personnel shall be familiar with the regulatory requirements (e.g. HSA, FDA etc.)


5. Personnel shall be able to develop good documents by following PharmaGend applicable guidelines & procedures.


6. Personnel shall be responsible for supporting the engineering operation including site new and retrofit projects related to manufacturing, utilities & facilities.


7. Personnel should have the ability to handle project documentation and coordination.


8. To assist on any ah-hoc duties that been assigned / task by the immediate superior.

Qualification

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