Job Description:
Our client is a world leader in the Biopharmaceutical and Biotechnology sector.
The role requires the candidate to author operating procedures / SOPs for various utility and process equipment associated with a new Pharmaceutical facility within specified project timelines.
Responsibilities and tasks include but are not limited to:
- Develop and author validation plans
- Maintain standard language and documentation structure / layout which allows for consistent execution of documents
- Reviewing of project documentation; Technical Specification and Functional Specification for automated and manual equipment
- Liaise with client end user groups to validate specification of equipment and utilities
- Providing engineering expertise and drive technical decisions as an active member of the team
Education and Experience
- Candidate must possess at least a Bachelor’s Degree in Engineering or Science
- Minimum 2 to 5 years’ relevant industry work experience in a cGMP environment
- Technical writing experience and / or experience with chemical API processes and procedures is preferred
- Ability to write technical procedures that are reflective of manufacturing operations/practices
- Possesses sound analytical problem-solving and documentation skills
- Must have the ability to review equipment manuals and develop operational procedures
- Complies with company policies, procedures, regulations
- Excellent written and oral communication skills in English
- Takes initiative with minimal supervision
- A structured and organised person
