SUMMARY:
Our client, a Global manufacturing concern, is in search of a qualified Engineer to co-ordinate projects of a technical nature aimed at:
- Developing new products/processes from conception through to realisation.
- Modifying existing products to improve quality, fitness for use and generate cost savings.
POSITION INFO:
Job Objective:
- Execute process and product in line with regulatory requirements and contribute to the Device Master Record (DMR) by compilation of product development and manufacturing documentation.
- Equipment qualification.
- Establish product ageing regimes and analyse data generated from these stability trials.
Minimum Job Requirements:- Bachelor’s Degree Industrial/Process Engineering.
- Min 3 to 5 years working experience in a production environment pref. within a medical / pharmaceutical environment.
The Job:
Reporting to the Initiative Manager:
- Plan and co-ordinate trials in accordance with business requirements:
- Production trials on new or existing products/packaging in the factories.
- Process or product validations on new or existing products/packaging in the factories.
- Co-ordinate assigned projects in accordance with company policies/regulatory requirements.
- Compile and execute qualification protocols and reports (SLIA, IQ/OQ).
- Execute performance qualification.
- Establish/compile stability protocols/report.
- Create new versions R&D technical and manufacturing documents (DIOS, UOUP, DMR, IPRS, PMCC, etc,).
- Compile cost estimates and feasibility studies of projects/products.
Competencies:- Accuracy of work (documentation, cost estimates).
- Meeting project deadlines.
- Proficiency in Microsoft packages, specifically Excel, Word, PowerPoint.
- Excellent problem-solving skills.
- Excellent verbal and written communication skills.
- Must be innovative.
- Must be able to work under pressure.
- Must be a team player and collaborative.
- Show commitment to the task at hand.
- Courage to innovate.
NB! This job is now closed. You can apply for other jobs by uploading your CV.
