Validation Engineering
$87.1k - $94.6kCAI
CAI is a professional services company established in 1996 that has grown year over year to nearly 800 people worldwide. For mission-critical and regulated industries that need to deliver critical solutions in high-stakes environments, we provide accelerated operational readiness and unparalleled performance at the highest standard through our rigorous approach, field-tested processes, and elite expertise developed over 30 years.We act with integrity- We serve each other- We serve society- We work for our futureAt CAI, we believe in a relentless dedication to excellence, pushing boundaries and surpassing expectations. We are bold in our thinking and creative in our approach. Key ResponsibilitiesCQV Execution & Safety- Perform Commissioning, Qualification, and Validation (CQV) activities with a strong focus on safety- Deliver C&Q activities in alignment with project schedules- Track and report progress of CQV effortsDocumentation & Compliance- Support the generation and review of C&Q procedures for client projects- Review and revise qualification-related documents, including SOPs, master plans, and execution plans- Assist with CQV review and qualification of equipment designProject Planning & Coordination- Support planning of commissioning spares and consumables- Allocate project resources for efficient execution- Coordinate support and logistics during CQV executionTesting & Vendor Management- Support execution of design reviews, equipment shakedown, commissioning, FATs, IQ, OQ, and PQ activities- Coordinate with project contractors and equipment vendors to execute required testingQualifications and Experience- Bachelor's degree (BS/BA) in Engineering, Chemistry, or Life Sciences (relevant experience can substitute for education)- 3+ years of related experience in the Pharmaceutical/Life Sciences industry- Essential experience in a GMP (Good Manufacturing Practice) environment- Outstanding oral and written communication skills- Strong problem-solving abilities- Customer-focused mindset- Willingness and flexibility to travel throughout the U.S. and potentially internationallyCritical CompetenciesInfluence Strategy- Evaluates and pursues opportunities based on organizational strategy- Identifies innovative solutions with strategic impact- Anticipates emerging customer and market needsSatisfy the Customer- Understands and anticipates client needs- Develops solutions that exceed expectations- Actively follows up to ensure satisfaction and loyaltyPlan for Success- Aligns business strategies with actionable plans- Allocates resources effectively- Anticipates risks and builds contingency plansPursue Execution- Prioritizes initiatives to ensure goal achievement- Holds self and team accountable- Proactively removes obstaclesTailor Communication- Communicates clearly, concisely, and professionally- Adjusts messaging to suit audience- Explains technical concepts across all levelsBuild Partnerships- Builds strong networks across teams and disciplines- Promotes collaboration and removes silos- Involves stakeholders in decision-makingInfluence Others- Builds support through sound reasoning- Gains buy-in from decision makers- Encourages innovation and better outcomesDevelop Self and Others- Continuously develops relationship and leadership skills- Acts with integrity and models company values- Seeks out breakthrough opportunities$87,100 - $94,600 a year average base salary range - not including benefits, and potential overtime and/or Cost of Living Adjustment.we are proud to employ veterans and promote diversity and inclusion in our workplace. Diversity is a strength for our global company. We pledge that CAI will be operated in a way that is fair and equitable to all – our employees, our customers, and the broader society.
$104k - $115.5k
...Job Summary Validation Engineer II is expected to execute validation and qualification activities for pharmaceutical manufacturing systems in compliance with cGMP requirements, industry standards, and standard operating procedures under guidance from Manager. Area...SuggestedWork at officeFlexible hours$72.8k - $80.1k
...workDirect small teams in document development and/or executionQualifications and Experience- Bachelor's degree in a science or engineering field (or equivalent experience)- 2–4 years' experience in commissioning and qualification in a regulated industry- Familiarity with...SuggestedWorldwide- ...Validation Engineer5 to 10 years' experience100% medical domain, medical implantsIQ, OQ, PQ, equipment qualification, process qualification in medical device manufacturingUnderstanding risk managementComplete document assessmentsNo licenses requiredWrite IQ, OQ, PQ protocols...Suggested
- ...related to system start up, commissioning, qualification, and validation. They will work towards ensuring compliance and quality... ...cycle development and PQ. Qualifications: Experience in Engineering, Commissioning, Qualification, and Validation processes Knowledge...SuggestedFull time
- .../GC NON-NEGOTIABLE ~ Bachelors Degree in Engineering (Biomedical, mechanical, chemical, or electrical) or Science (Biology, Chemistry). ~4 to 7 years of experience in a Validation or Quality Assurance role for a medical device or pharmaceutical...SuggestedRemote work
$87.1k - $94.6k
...Execution & Safety- Perform Commissioning, Qualification, and Validation (CQV) activities with a strong focus on safety- Deliver C&Q... ...testingQualifications and Experience- Bachelor's degree (BS/BA) in Engineering, Chemistry, or Life Sciences (relevant experience can...For contractorsWorldwide- ...Responsibilities: Apply quality standards and cGMP requirements to validate computer systems, including hardware, software, procedures,... ...Counters, and Excel spreadsheet validation. Bachelor's degree in Computer Science, Engineering, Biological Sciences, or a related field.
- Integra LifeSciences is seeking a Staff Engineer - Supplier Quality Validation Engineer in New Jersey with hands-on experience in IQ/OQ/PQ validation to drive continuous improvement and supplier quality across surgical and tissue technologies divisions. The role requires...
- ...Validation Engineer IIThe Validation Engineer II ensures compliance and operational excellence by managing validation processes across sterile and non-sterile manufacturing. It oversees multiple projects, develops documentation, and collaborates with teams to enhance efficiency...For contractorsWork at officeImmediate startShift work
- ...Job TitleR3 Technology Inc. seeks Validation Engineer for its Hillsborough, NJ office.Responsibilities include gathering requirements to develop product-level requirements and assisting with the high-level systems view of product design. Conduct multi-disciplined product...Work at officeRelocation
$75k - $142.5k
...Job TitleAn engineering professional that works with project engineers, stakeholders, and other project team members to complete tasks... ...of the project.ResponsibilitiesDevelop, execute and implement validation documentation - specification documents, SOPs, IQ/OQ/PQ...Temporary workWork at officeLocal areaImmediate startRemote workMonday to Friday- ...Job Summary: This role will focus on the Computer System Validation (CSV) activities for enterprise GxP systems, specifically for... .... Education & Experience: Bachelor's degree in Engineering, Pharmaceutical Sciences, Chemistry, Biology, or a related scientific...
- ...projects of $1m or more, and have managed teams of at least 6-8 engineers and consultants on defined scopes of work.A successful CAI PM... ...00 people worldwide. We provide commissioning, qualification, validation, start-up, project management and other consulting services...Full timeWorldwide
- ...ETL Test Engineer Join our team as a dedicated ETL Test Engineer, where you will play a crucial role in ensuring the integrity and... ...Qualifications: Strong experience in ETL Testing with expertise in validating data extraction, transformation, and loading processes....Work experience placementLocal area
- ...MS in Electrical / Electronics with 8 years experienceResponsibilities:- Work with equipment / software / electronic hardware / validation/reliability and manufacturing fields- Design and implement electrical/mechanical systems for container refrigeration- Create, refine...
$90k - $120k
...2017 About the Job: The position reports to the Sr. Validation Manager and is responsible for supporting commissioning, qualification... .... Coordinate validation activities with Manufacturing, Engineering, QA, QC, Automation, and external vendors. Participate...Full timeTemporary workWork experience placementFlexible hours$90k - $157.5k
Network Security Operation Engineer will be responsible for implementing and maintaining systems to protect State Street’s network infrastructure. This includes managing security policy, conducting security audits, and analyzing security & network traffic. Additionally...Full timeTemporary workFlexible hoursWeekend work- ...function and assuring no quality escapes Document the complete test process Training technicians on assembly and test process. Validate technicians on competency to assembly & test process Requirements: 2-5 years experience in a manufacturing...
- RBC Bearings is a well-known international manufacturer and marketer of highly engineered precision plain, roller and ball bearings. We have been providing bearing solutions to our customers since 1919. Over the past ten years, under the leadership of our current management...Full time
$59.15k - $106.93k
...thrive, professionally and personally. For us, helping you grow your career is good business. Leidos is seeking Distribution Engineers & Designers in the Eastern , PA region who are passionate about electric utility design engineering. We’re looking for...Work at officeLocal areaImmediate startRemote workFlexible hours$71.3k - $97.75k
...advance patient outcomes and set new standards of care.The Process Engineer is responsible to understand, optimize, and sustain... ...introductions, etc.Lead & execute engineering studies, IQ/OQ/PQ/TMV validations, manufacturing process requirements, specifications, Engineering...Contract workTemporary workImmediate start$62.1k - $85.1k
...functional teams addressing quality improvements, lifecycle management efforts, new product introductions, etc.Execute engineering studies, IQ/OQ/PQ/TMV validations, manufacturing process requirements, specifications, Engineering Change Requests/Orders (ECR/ECO), and...Temporary workImmediate start$71.3k - $97.75k
Integra LifeSciences is seeking a Process Engineer in Plainsboro Township, NJ, to optimize and sustain manufacturing processes. The role involves cross-functional collaboration to enhance workflow and efficiency while ensuring compliance with FDA regulations and other...- ...Process Engineer IThe Process Engineer I is mainly participating and assisting in the preparation of the deliverables of the Process Design Packages in the frame of Licensing contracts, on the specific tasks described here below and under the supervision of Senior or...Work at office
$140k - $155k
...use):11Job DescriptionThe Team:The Cyber Fusion Center protects the business by fusing threat intelligence, monitoring, detection engineering, and response into one proactive, intelligence-led defense capability that breaks down silos to reduce risk and strengthen...Full timeSecond jobLive inWorldwideFlexible hours$95k - $145k
Position Summary Drive validation and compliance activities for complex GxP systems as a Senior Consultant, Regulatory, Risk,... ...s degree in business, information systems, computer science, engineering, or equivalent experience; 6+ years of experience in computer...Remote workVisa sponsorship$90k - $95k
...Automation EngineerThe Automation Engineer will support, maintain, and troubleshoot plant automation systems in a highly technical manufacturing environment. This role focuses on ensuring reliable operation of programmable logic controllers, human machine interfaces,...Permanent employmentFlexible hours$125k - $135k
...Sr. Manufacturing EngineerThe Sr. Manufacturing Engineer is responsible for maintaining, improving, and building new production capabilities... ...devices.Develop and perform engineering studies and process validations.Analyze production processes and identify opportunities to...- ...capabilities with marketing objectives.• Apply your expertise in engineering principles and financial acumen to enhance diagnostic... ...installation, scale-up, optimization, automation, trouble shooting and validation of manufacturing processes or equipment. Aids in the...Work at office
$105k - $115k
...headquarters is located in Monroe Township, New Jersey and has an additional office in Richmond, California.The RoleThe Manufacturing Engineer is responsible for the development, implementation and documentation of the manufacturing process. They will serve as the link...Work at officeLocal areaRemote work
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