Senior Specialist Engineering (Documentation & Validation Execution)

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.