Job Summary
Description:
The CSV Engineer GAHM IT is a member of one or more project teams and support those teams to achieve the relevant qualification and validation goals.
Responsibilities:
• Writing, review, and approval of validation documentation
• Maintain accurate validation documentation
• Train other staff members on the correct use of computerized systems in line with protocols and regulations
Qualifications
Required:
• Bachelor's degree in business, information systems or related discipline, or equivalent and extensive related project experience.
• Experienced with GxP regulated environment
• Eager to participate in integration and management of Manufacturing Systems
• Able to work with moderate direction
• Ability to adapt to rapidly changing technology and apply it to business needs.
• Able to think out of the box on situation dependent issues;
• Organizational savvy; leveraging social network to escape hierarchy. Adept at managing diverse relationships across expertise, geography and culture.
• Open and receptive to listening, and discerning pain points; Embraces new ideas, evidence and fosters a collaborative atmosphere
• Excellent written communication skills, fluent in English
Preferred:
• Automation domain knowledge (ISA 95 level 2/3)
• Experience with Systems Development Lifecycle Methodology (SDLC)
Key Responsibilities
2. To develop and guide the team members in enhancing their technical capabilities and increasing productivity
3. To ensure process compliance in the assigned module| and participate in technical discussions/review as a technical consultant for feasibility study (technical alternatives, best packages, supporting architecture best practices, technical risks, breakdown into components, estimations).
4. To prepare and submit status reports for minimizing exposure and risks on the project or closure of escalations.