Validation Engineer II
4 weeks ago
PACIV is a global leader in industrial automation and process control solutions, serving clients in the life sciences, pharmaceutical, medical device, food & beverage, and utilities sectors, specializing in delivering compliant, high-performance automation systems tailored to regulated environments.We are seeking a detail-oriented and proactive Validation Engineer II for our Indianapolis, IN office to support compliance and efficiency in a regulated environment. This role is responsible for executing and managing periodic reviews of computer systems, and driving resulting action items to completion.. The ideal candidate will collaborate cross-functionally to create, revise, and control technical documents, while also supporting system updates and process improvements.Job ResponsibilitiesExecute Periodic Reviews of all departmental computerized systems supporting Clinical Trials (i.e. Parts Washers, Autoclaves, Filtration Systems, etc.)Create, track, and drive to completion action items for any deficiencies resulting from Periodic Reviews.Update Computer System Validation (CSV) documentation which may include design documents, local policies and procedures, tools, forms, and assessments.Support the development of reporting tools and methods to enhance visibility into periodic review progress and project metrics.Review validation documentation and ensure accuracy and compliance with local department and industry standards.Collaborate with cross-functional teams to ensure outputs of periodic reviews and any other CSV-related project deliverables meet local and regulatory requirements.QualificationsBachelor’s degree in a relevant field (e.g., Life Sciences, Engineering, Technical Writing, or Information Systems)Minimum 8 years proven experience in validation documentation within regulated environments (e.g., pharmaceutical, biotech, or life sciences).Strong understanding of Good Documentation Practices (GDP) and GMP compliance.Experience with TrackWise or similar quality management systems.Ability to collaborate with Subject Matter Experts to develop and revise technical documentation.Excellent attention to detail and organizational skills.Strong communication and stakeholder engagement abilities.Compensation & Benefits HighlightsPACIV offers a competitive salary with a comprehensive benefits package designed to support the well-being and financial future of our employeesGenerous Paid Time Off - Vacation, sick leave, and company-recognized holidays.Healthcare Coverage - PACIV covers 90% of your healthcare premiumHealth Savings Account (HSA) – Bi-monthly company contributions to cover out-of-pocket medical expenses.401(k) Retirement Plan - Company match up to 4% & full vestiture on enrollment datePACIV is an Equal Opportunity Employer. We are committed to creating an inclusive environment for all employees and applicants. All qualified candidates will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, or any other legally protected status.PACIV complies with all applicable federal, state, and local laws regarding non-discrimination and affirmative action. Employment is contingent upon successful completion of background checks and eligibility to work in the United States.
-
Validation Engineer II
7 days ago
Indianapolis, United States PACIV Full timeValidation Engineer II PACIV stands for P rocess A utomation, C ontrols, I nstrumentation, and V alidation. As a global leader in industrial automation, process control solutions and instrumentation, we serve clients in the life sciences, pharmaceutical, medical device, food & beverage, and utilities sectors, specializing in delivering compliant,...
-
Validation Engineer II
4 weeks ago
Indianapolis, United States PACIV Full timePACIV is a global leader in industrial automation and process control solutions, serving clients in the life sciences, pharmaceutical, medical device, food & beverage, and utilities sectors, specializing in delivering compliant, high-performance automation systems tailored to regulated environments.We are seeking a detail-oriented and proactive Validation...
-
Validation Engineer II
4 weeks ago
Indianapolis, United States IPS-Integrated Project Services Full timeJob DescriptionAt IPS, we are global leaders in developing innovative solutions for the consulting, architecture, engineering, project controls, procurement, construction management, and CQV of technically complex facilities, primarily in the life sciences industry. We are looking for a talented CQV Engineer II to join our team at our office located in...
-
Validation Engineer II
2 weeks ago
Indianapolis, United States IPS-Integrated Project Services Full timeJob DescriptionAt IPS, we are global leaders in developing innovative solutions for the consulting, architecture, engineering, project controls, procurement, construction management, and CQV of technically complex facilities, primarily in the life sciences industry. We are looking for a talented CQV Engineer II to join our team at our office located in...
-
Validation Engineer II
5 days ago
Indianapolis, Indiana, United States PACIV Full timePACIVis a global leader in industrial automation and process control solutions, serving clients in the life sciences, pharmaceutical, medical device, food & beverage, and utilities sectors, specializing in delivering compliant, high-performance automation systems tailored to regulated environments.We are seeking a detail-oriented and proactiveValidation...
-
Validation Engineer II
5 days ago
Indianapolis, Indiana, United States PACIV Full timePACIV is a global leader in industrial automation and process control solutions, serving clients in the life sciences, pharmaceutical, medical device, food & beverage, and utilities sectors, specializing in delivering compliant, high-performance automation systems tailored to regulated environments.We are seeking a detail-oriented and proactive Validation...
-
Validation Engineer II
2 weeks ago
Indianapolis, United States Novartis Group Companies Full timeJob Description SummaryAt Advanced Accelerator Applications, a Novartis company, we are committed to leading innovation in nuclear medicine and delivering the next generation of targeted radioligand therapy to cancer patients. We are looking for experienced Manufacturing professionals to help us reach our ambitious goals.The Validation Engineer will execute...
-
Validation Engineer II
4 weeks ago
Indianapolis, IN, United States IPS-Integrated Project Services Full timeJob Description At IPS, we are global leaders in developing innovative solutions for the consulting, architecture, engineering, project controls, procurement, construction management, and CQV of technically complex facilities, primarily in the life sciences industry. We are looking for a talented CQV Engineer II to join our team at our office located in...
-
MV01-080725 Sr Validation Specialist
6 days ago
Indianapolis, United States Validation & Engineering Group, Inc Full timeDepartment: Field - NB Location: Indianapolis, IN START YOUR APPLICATION Validation & Engineering Group, Inc. (V&EG) is a leading services supplier who provides solutions for the Pharmaceutical, Biotechnology, Chemical, Food, and Medical Devices industries in the following areas: Laboratory, Compliance, Computer, Engineering, Project Management, Validation,...
-
Validation Engineer
4 weeks ago
Indianapolis, United States Process Alliance LLC Full timeDirect message the job poster from Process Alliance Were hiring a Validation Engineer to support Computer System Validation (CSV) and system qualification activities in a regulated pharmaceutical environment. This role is ideal for someone with strong documentation skills and experience working with electronic systems, validation deliverables, and change...
