Description
Skills: Pharma, Serialization, Commissioning and Qulification Packaging equipment, Support, Validation, I/Q, OQ, PQ, GMP
Position: Industrial/IT Automation
Duration: 24 Months
Location: Fegersheim (Close to Strasbourg), France
Job Description
Industrial/IT Automation, Pharma Serialization, Commissioning and Qualification of packaging equipment
Required Skills
Experience of providing Tier-1 support to pharma manufacturing/packaging solutions.
Excellent problem solving and analytical skills
Should be comfortable to work in the shifts and the on-call,
Ability to troubleshoot software/hardware issues and provide timely resolution.
Excellent understanding of Incident and Change management tools and processes
Excellent analytical, organizational, team and project management skills
Excellent written/verbal communication skills
Strong documentation skills - should have experience of writing requirement specifications, design documents, test summary reports etc.
Good understanding of writing and executing validation plans, I/Q, OQ, PQ process
Strong understanding of software development life cycle and maintenance plans
Experience of working in a support role/organization
Understanding of SQL server databases, Sharepoint, Visual Basic
Ability to co-ordinate with cross cultural teams (TCS/Vendor/Customer), close process gaps and provide value improvement ideas.
Understanding of GMP process, GMP systems used in Pharma
Should able to speak French
Desired Skills
Understanding of Pharma Serialization.
Knowledge of Automation control systems, automation software.
Understanding of Systech® Suite of products and vision systems.
Familiarity with pharma packaging processes and packaging equipment custom software
Experience in providing engineering support in pharmaceutical manufacturing and packaging operations
Worked in direct support of and along with the maintenance staff to maintain both complex and simple systems used in packaging operations
Understanding of Packaging line hardware, PLC programming.
Experience of vision inspection systems used in packaging.
Provide Level 1 support to Serialization execution System.
Coordinate with remote teams teams in Automation/software qualification and software validation activities and further provide assistance to Serialization support team to manage serialized lines.
Develop and support a global, repeatable, and logical process to effectively resolve any issues arising from the installation and subsequent operation of Serialization hardware components in packaging operations.
Providing updates to customers regarding ongoing issues.
Maintain and update procedures as required.
Updating Engineering, User requirement and design documents for any change made to Serialization system.
Maintain Spare Parts inventory and communicate effectively on time for any new spare parts requirements.
Formal investigation of support issues, communication with impacted stakeholders, vendor, resolution/closure of the issue, and updating appropriate knowledge management records.
Resource should be quick learner and self-driven; capable of meeting with Business Users and working cross-functionally to define requirements, configure and deploy solutions
Ability to plan and prioritize work effectively to meet defined delivery levels in a customer facing role.