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6 days ago
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Validation Engineer


Salary band: $10k - $15k
Location: North America, United States, New Jersey
Job type: Permanent
Contact: Scientific Search
Category: Engineer
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Job Description:

Validation Engineer (5 mo. contract) Essential Duties & Responsibilities As a part of the company validation team, the individual will be involved with qualification of a new facility.Work collaboratively to develop and execute validation protocols, such as IQ/OQ/PQ in accordance with the validation master plan.Write and execute validation protocols and comprehensive final reports including thorough resolution of protocol deviations or non?conformances.Responsible for technical review of validation protocols, reports, user requirements, and assessment of change controls and incident reports.Responsible for revising or creating SOPs and work instructions.Ensure validation efforts are in compliance with both company quality assurance standards and applicable government regulations, such as FDA and ISO requirementsAssess process changes for possible revalidation requirements in accordance with the quality management systemEstablish and maintain good rapport with both internal and external customers, while driving solutions to meet business needs. Develop and maintain a strong spirit of partnershipCollaborate with stakeholders to summarize validation results in final reportsAssist in documenting and resolving deviations encountered during execution of validation activitiesSupport the change management process for automation system validationMay assist in the development of contracts and procedures to ensure compliance to applicable regulatory requirementsExperience with process control applications is desirable, including knowledge of historians, manufacturing executions systems, SCADAs, PLCs, and Emerson DeltaV distributed control systems. Desired Skills and ExperienceBachelors degree in Engineering or Science3?7 years' experience in FDA related manufacturing or process operationsKnowledge of FDA regulations and GMPsFamiliar with facilities and equipment, utilities, calibration, IQ, OQ, PQ, and development of SOPs. Familiarity with air separation process a plus.Knowledge and understanding of FDA regulations, 21 CFR Part 11 requirements and cGMPs. Experience with cGMP application to medical gases and air separation a plus.Familiarity with many aspects of validation is expected.Experience with Process and Automated Equipment ValidationExperience conducting root cause analysis, gap analysis, and risk assessments. HACCP familiarity a plus.Experience in writing and executing protocols for process validation and computer controlled systems validation.Working knowledge of validation test instruments and equipment.Excellent oral and written communication skillsExcellent organizational and time management skillsStrong decision making and creative problem solving skillsAbility to develop, organize, and manage multiple tasksAbility to plan and manage own workProficient in Microsoft Word, Excel, Power Point and Project. In addition to the above technical competencies, ideal candidates will have a commitment to delivering quality documents and service excellence. Candidates must be results?oriented, able to make decisions, and able to prioritize work per business needs. Strong communication, organization, and time management skills are necessary as well as teamwork, leadership, and the ability to maintain constructive relationships with personnel from various disciplines at all levels in the organization. The successful candidate should demonstrate integrity, reliability, dedication, adaptability, innovation, and self?motivation.

Company Description:

Since 1983, Scientific Search has been placing technical, management, and executive level professionals. We have been named one of the fastest growing, privately held companies in South Jersey by the Philadelphia Business Journal six times, and one of the prestigious Philadelphia 100 companies on four occasions including this past year. We are also a member of the nationally recognized Inc. 5000. In 2015, we were recognized as one of the best places to work in NJ.
Job Description:

Validation Engineer (5 mo. contract) Essential Duties & Responsibilities As a part of the company validation team, the individual will be involved with qualification of a new facility.Work collaboratively to develop and execute validation protocols, such as IQ/OQ/PQ in accordance with the validation master plan.Write and execute validation protocols and comprehensive final reports including thorough resolution of protocol deviations or non?conformances.Responsible for technical review of validation protocols, reports, user requirements, and assessment of change controls and incident reports.Responsible for revising or creating SOPs and work instructions.Ensure validation efforts are in compliance with both company quality assurance standards and applicable government regulations, such as FDA and ISO requirementsAssess process changes for possible revalidation requirements in accordance with the quality management systemEstablish and maintain good rapport with both internal and external customers, while driving solutions to meet business needs. Develop and maintain a strong spirit of partnershipCollaborate with stakeholders to summarize validation results in final reportsAssist in documenting and resolving deviations encountered during execution of validation activitiesSupport the change management process for automation system validationMay assist in the development of contracts and procedures to ensure compliance to applicable regulatory requirementsExperience with process control applications is desirable, including knowledge of historians, manufacturing executions systems, SCADAs, PLCs, and Emerson DeltaV distributed control systems. Desired Skills and ExperienceBachelors degree in Engineering or Science3?7 years' experience in FDA related manufacturing or process operationsKnowledge of FDA regulations and GMPsFamiliar with facilities and equipment, utilities, calibration, IQ, OQ, PQ, and development of SOPs. Familiarity with air separation process a plus.Knowledge and understanding of FDA regulations, 21 CFR Part 11 requirements and cGMPs. Experience with cGMP application to medical gases and air separation a plus.Familiarity with many aspects of validation is expected.Experience with Process and Automated Equipment ValidationExperience conducting root cause analysis, gap analysis, and risk assessments. HACCP familiarity a plus.Experience in writing and executing protocols for process validation and computer controlled systems validation.Working knowledge of validation test instruments and equipment.Excellent oral and written communication skillsExcellent organizational and time management skillsStrong decision making and creative problem solving skillsAbility to develop, organize, and manage multiple tasksAbility to plan and manage own workProficient in Microsoft Word, Excel, Power Point and Project. In addition to the above technical competencies, ideal candidates will have a commitment to delivering quality documents and service excellence. Candidates must be results?oriented, able to make decisions, and able to prioritize work per business needs. Strong communication, organization, and time management skills are necessary as well as teamwork, leadership, and the ability to maintain constructive relationships with personnel from various disciplines at all levels in the organization. The successful candidate should demonstrate integrity, reliability, dedication, adaptability, innovation, and self?motivation.

Company Description:

Since 1983, Scientific Search has been placing technical, management, and executive level professionals. We have been named one of the fastest growing, privately held companies in South Jersey by the Philadelphia Business Journal six times, and one of the prestigious Philadelphia 100 companies on four occasions including this past year. We are also a member of the nationally recognized Inc. 5000. In 2015, we were recognized as one of the best places to work in NJ.

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