Validation Engineer

at  ORION

Job description

JOB/TECHNICAL SKILLS

• A minimum of 5-10 years’ experience in a cGMP regulated environment.
• A good understanding of regulatory requirements.

COGNITIVE/BUSINESS SKILLS

• Requires a high level of attention to detail and mental concentration, to ensure accuracy and total compliance with procedures at all times.
• Requires proven problem-solving skills and the ability to adapt to new regulatory requirements.
• Requires innovative thinking, where new and untested solutions are proposed, demonstrated and implemented on a regular basis.
• Must be results driven striving to meet all targets and metric standards as set by site/department and division leaders.
• Requires total commitment to quality and maintaining a high standard of work at all times.
• Demonstrates the highest levels of integrity and a strong work ethic at all times
• Strong communication skills both verbal and written are required for the execution of this role.
• Strong interpersonal skills are required.
• Supports the principles of Perfect Performance.

OWNERSHIP AND ACCOUNTABILITY

• The position has a high level of autonomy and individuals are expected to work on their own initiative.
• Adheres to and follows all procedures policies and guidelines ensuring compliance with cGMP and HPRA/FDA regulations and company policies, procedures and guidelines.
• Individual is fully responsible for the co-ordination and closure of projects assigned.
• This position is crucial in identifying systems requiring validation and ensuring that this activity is documented, actioned and resolved.
• This position impacts on product quality and technical performance as well as manufacturing operations.
• Requires an ethos of Right First Time at all times.

Purpose:

• To coordinate the development and maintenance of the company’s validation program in
• compliance with all applicable regulatory and company requirements.
• Co-ordination, implementation and active participation in the site Validation Program

Responsibilities:

• Ensure all Computerized systems are qualified in compliance with Data Integrity policies and regulatory requirements.
• Co-ordination / direction and active participation in the validation of site equipment,facilities, utilities, processes and software in compliance with company policies, FDA, European cGMP and GAMP standards.
• Generation/maintenance of the Validation Master Plans.
• Generation/maintenance of Project Validation Plans.
• Generation of validation plans, protocols and final reports to cGMP standard.
• Review / approval of all protocols and final reports.
• Management of validation change control process.
• Adheres to and supports all EHS & E standards, procedures and policie