Validation Engineer 23 views

Purpose:

A pharmaceutical manufacturing company is seeking a Validation Engineer who has 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

Key Job Outputs:

• 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 environment, 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
• Complete all records and reports timeously and accurately as described in the relevant SOP’s, protocols and associated documentation
• Comply with GMP requirements as outlined by company SOP’s and written instructions in all tasks and activities
• Ensure that products are stored according to the required SOP’s and documentation
• Ensure all sections within department maintain compliance to company GMP standards
• Carry out any duty or requirement imposed on the company by the OHS Act and in accordance with your specific SHE appointment
• Report any unsafe or unhealthy situations to SHE representative or Line Manager
• Report any incident to the SHE representative or Line Manager which may affect your health or cause injury
• Ensure all sections within department maintain compliance to company OHSE standards

Core Competencies:

• 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
• 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

Qualifications:

• Min National Diploma in Chemical or Mechanical Engineering or BSC Chemistry (or similar)

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
• Knowledge of cGMPs as applied in an FDA-controlled environment, preferred

Salary:   Market related

Should you not hear from us within 2 weeks, kindly consider your application as unsuccessful.

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