Hi BusinessPartners,
Hope you are doing great!
Please find below mentioned job description and revert back with the updated resume to lucky@itstrategiesinc.com
Job Title: IT Validation Engineer
Location: MORRIS PLAINS,New Jersey
Duration: 6+ Months
Number Of Positions#3
Additional Notes - Experience in Pharma domain required
Job Description -
Position Summary
Reporting into Technical Director of IT, the Validation Engineer will assure that computerized systems are qualified in a manner that satisfies company policies and regulations established by regulatory agencies such as FDA, EUHA, etc. The Validation Engineer will implement an effective and efficient validation strategy for the CLIENT IT function which will ensure that the scope of validation activities addresses business and compliance needs for all computerized systems at CLIENT. The Validation Engineer will be responsible for the implementation and enforcement of CLIENT IT risk-based computerized system validation (CSV) strategy across all local and enterprise solutions (including, but not restricted to, Document Management Systems (DMS), QMS (Quality Management Systems), Building Management Systems (BMS) and Clinical Data Management Systems (CDM), Process Control Systems (PCS) etc.). This will include advising the Technical Director on compliance with and potential changes to existing procedures, processes and templates as necessary, together with the provision of appropriate training to members of the CLIENT IT function and business users as necessary.
The role holder will manage the qualification of new systems, as well as changes to existing systems, and will work closely with the lead solution architects, the engagement and deployment teams, and the offshore development team(s), to ensure that CSV requirements are met.
This role will take on responsibility for the CSV elements for all systems by updating validation plans, reviewing all validation deliverables, reviewing testing coverage to ensure adequacy, performing system and supplier assessments, managing the change control process, and conducting risk analysis in order to drive and implement process improvements as required.
The Validation Engineer will embed excellence, champion process change and develop a continuous improvement framework across the CSV organization. The role holder will need to influence key stakeholders, engage and develop senior leaders in leading CSV compliance, and ensure that technology is used to support an effective and efficient approach to CSV in order to minimize business disruption.
Key Responsibilities
· Assist the Technical Director in defining the CLIENT IT validation strategy and approach taking into account the relevant GxP requirements (e.g.GAMP5, FDA 21 CFR Part 11, Part 210, 211, 820 etc.) and also other relevant regulatory requirements (e.g. SOx, data privacy/protection, etc.).
· Develop and standardize appropriate procedures to be used in validating computerized systems:
o Develop, review and approve CSV policies, procedures, plans and protocols, and champion their adoption.
o Manage and control validation documentation in collaboration with QA teams.
o Manage, coordinate, and/or perform the development of: Validation and Test plans, specifications (e.g. User Requirements Specification, Functional Specification, etc.) supplier assessment, user acceptance testing, traceability, and compilation of the data and results into final reports.
o Schedule and lead meetings with IT, QA, and end user representatives in order to gain cross functional understanding and consensus on protocol content and protocol execution.
o Lead and/or coordinate investigations into failures to meet acceptance criteria, and determine and implement appropriate resolutions.
· Review proposed changes to validated computerized systems and identify the validation requirements necessary to maintain the system's validation status after execution of the change.
· Assess proposed new computerized systems or software to assess GxP impact and where GxP impact is identified provide guidance on the risk based validation approach for the system, working with key stakeholders to achieve business goals.
· Manage all validation aspects as part of project work, or act as lead for specific validation project resources.
· Manage formal testing of computerized systems including identifying and implementing tools, setup of testing, documentation, approval and delivery.
· Maintain up to date knowledge of evolving regulatory requirements, availability of current/new techniques, and literature regarding compliant computer operations, and act as an information resource for the team and wider business.
Qualifications
Technical Skills
· Familiarity with multiple system types such as ERP and BMS, eQMS, DMS, LIMS etc.
· Good understanding of business requirements, high-level solutions and infrastructure components, combined with CSV system experience.
· Project Definition and initiation experience related to CSV
· Adept at spearheading parallel projects aligned with the IT PMO strategy.
· Deep understanding of business processes and what is needed to effect changes.
· Able to effect win-win solutions among disparate stakeholders.
· Change management skills (stakeholder management, communications strategy and planning, knowledge management, training, etc.).
Team Skills
· Effective people management skills, able to adopt appropriate styles to foster strong team working environments, minimize and manage conflict and cultivate a culture of mutual respect.
· Confident communicator, able to network effectively in a diverse business community.
· Proactive, professional approach undertakes tasks and responds to business requests in a positive and constructive manner.
· Keeps industry and organization knowledge current in order to provide up to date solutions and be best placed to advice on future capabilities.
· Able to balance the financial, quality, people and business needs aspects of solutions.
· Effective in understanding and anticipating business needs, able to manage expectations appropriately and meet business needs in line with organizational capabilities and standards.
· Effective, continuous team communication to promote open, honest information sharing and encourage input from team members on how to improve CSV approaches / team performance.
· Empowering style, encouraging creativity and innovation to delivery of BPO objectives.
Education & Experience
· Degree or equivalent qualification in a relevant discipline combined with significant experience in similar validation role within the life sciences industry and a thorough knowledge and understanding of the GxP regulations and CSV requirements and expectations.
· Demonstrable experience of successfully managing complex validation projects, ideally including experience of successful validation of electronic Quality Management Systems (QMS), Enterprise Resource Planning systems (ERP), etc.
· Excellent organizational skills, with a pro-active, self-motivated approach, able to work effectively with minimum direction, exercise considerable latitude in determining assignment objectives, determine appropriate methods to apply to new assignments, and prioritize and simultaneously manage multiple projects and deadlines, ensuring compliance to global CSV processes at all times.
· Ability to effectively manage a wide range of complex, cross-functional area problems through application of technical skills, ingenuity and creativity.
· Experience of providing guidance and working with the company personnel and contractors.
· Experience of involvement in regulatory inspections and audits, able to guide as a backup contact for the CSV validation program for inspectors during inspections and audits.
· Proficient communicator with excellent written and verbal communication skills. Fluent English language skills (verbal, written, presentation).
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