Job Description

Fine Chemicals requires the services of a Validation Engineer for our Engineering Department
Job specification: The position requires an individual with demonstrated interpersonal skills, leadership and management ability, assertiveness, and pragmatism. Technically, the position requires a high level of knowledge and skills in the following:

• Demonstrated understanding of chemical process equipment operation/installation/design and maintenance.
• Basic understanding or process control systems.
• Understanding technical specifications and drawings.
• Commissioning and qualification of equipment and systems in a GMP environment.
• OHS Act + Safe working practices and general industrial health and safety.
• Problem Solving, Leadership and General Supervisory Skills.
• Knowledge of cGMPs as applied in an FDA-controlled environment, preferred.

Experience: Experience in validation of equipment and systems within a GMP environment would be advantageous. Min 5 yrs experience in design, installation, commissioning / qualification, operation or maintenance of chemical process plant and equipment.
Personal attributes and qualifications:

• Min National Diploma in Chemical or Mechanical Engineering or BSC Chemistry (or similar)
• High standard of computer literacy and technical report writing.
• An assertive individual with good communication, organisational and interpersonal skills who thrives under pressure.
• Systematic and Analytical by nature.
• Must be of sound health, have own transport.

Principle objectives of the position:

• Responsible for appropriate application of validation and qualification policies and procedures to new and existing equipment, systems, facilities and utilities used in the manufacturing of intermediate and finished active pharmaceutical ingredients (API).
• Ensure validation compliance through coordinating the practical aspects of equipment validation and qualification as it pertains to the manufacturing enviroment, within the required timeframes.
• Maintenance (and generation of) of all validation related documentation and databases including, site master validation plan, various project master validation plans, Engineering Change Controls, ISO 14644 Compliance documents.
• Generation and maintenance of re-validation or re-qualification plans for all process equipment /systems as per the Site Master Validation Plan and associated Modular verification Procedure.
• Assisting with process and equipment related risk assessments.
• Supervising of Validation technicians and Interns as required.

Suitably qualified applicants are invited to submit their CVs online on or before the specified date. Preference will be given to applicants from designated groups in accordance with laws governing employment equity, where such laws are applicable to the Aspen entity that will employ the successful candidate. If you have not heard from the HR department within 30 days of this advert closing, please consider your application unsuccessful.