Validation Engineer

Orion Group Life Sciences are currently recruiting a Validation Engineer on behalf of our Multinational Pharmaceutical Client based in Sligo on an initial 12-Month contract.

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 policies

Supervision Received

• Individual is given authority to carry out their duties without close supervision.
• Reports to Validation Team Leader.
• Goals are reviewed on a regular basis and formal performance reviews are carried out once per year.

Supervision Provided

• No direct reports.
• Provide guidance to functional areas the area of Validation.
• May provide cross training and guidance to new department members.

Qualifications:

• 3rd level qualification in a relevant engineering or scientific discipline.

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.

Influence/Leadership

• Close contact with employees within the plant at all levels.
• Close contact with internal and external auditors, e.g. FDA, HPRA.
• May lead and chair Cross Functional Team meetings.
• Provide technical leadership to functional areas and collaborates with key stakeholders.

Decision Making/Impact

• Expected to provide functional expertise to support daily operations.
• Seeks Managers input when making decisions which affect the area.
• Is a site SME on validation issues and provides guidance on same.
• Decision making within confines of agreed responsibility with Team Leader.

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Our role in supporting diversity and inclusion
As an international workforce business, we are committed to sourcing personnel that reflects the diversity and values of our client base but also that of Orion Group. We welcome the wide range of experiences and viewpoints that potential workers bring to our business and our clients, including those based on nationality, gender, culture, educational and professional backgrounds, race, ethnicity, sexual orientation, gender identity and expression, disability, and age differences, job classification and religion. In our inclusive workplace, regardless of your employment status as staff or contract, everyone is assured the right of equitable, fair and respectful treatment.