5 Validation Plans Jobs

You should have a Bachelor's degree in Mechanical Engineering, Automotive Engineering, or a Master's degree in Mechatronics with 4 to 6 years of experience in the field. As part of your role, you will be responsible for designing, developing, and validating steering systems for heavy commercial vehicles (HCVs). Your key qualifications should include a strong understanding of Hydraulic and Electric Power Steering (EPS) systems and components, experience in preparation and validation of specifications, proficiency in 3D/2D CAD tools such as CATIA, and hands-on experience in Casting/Forging manufacturing design. Additionally, you should have experience with tolerance stack-up analysis, DFMEA, vehicle packaging, integration of steering systems, and knowledge of global automotive standards and regulations. It is essential for you to have hands-on experience in defining and executing validation plans, analyzing test data, implementing design improvements, collaborating with cross-functional teams, coordinating with suppliers, conducting drawing reviews, ensuring quality assurance, and maintaining design documentation, BOMs, and change management. Exposure to mechatronic systems, simulation tools for steering dynamics, functional safety standards, Agile or model-based development environments, cost optimization, design-to-manufacture principles, supplier audits, and product development processes is also required. Additionally, it would be beneficial if you have exposure to steer-by-wire technologies and PLM tools like Windchill, OAS, Enovia, and Teamcenter. Strong presentation and technical documentation skills are essential for this role.,

You should possess a Bachelor's degree in Mechanical Engineering, Automotive Engineering, or M-Tech in Mechatronics with 4 to 6 years of experience. As a member of our team, you will be responsible for the design, development, and validation of steering systems for heavy commercial vehicles (HCVs). Your role will require a strong understanding of Hydraulic and Electric Power Steering (EPS) systems and their components, such as torque sensors, actuators, and steering columns. You should have experience in preparing and validating specifications and be proficient in 3D/2D CAD tools like CATIA. Hands-on experience in Casting/Forging manufacturing design, tolerance stack-up analysis, and DFMEA is essential. Moreover, you should have knowledge of vehicle packaging, integration of steering systems, and familiarity with global automotive standards and regulations such as ISO, SAE, and FMVSS. Experience in defining and executing validation plans, analyzing test data, and implementing design improvements is crucial. Strong collaboration skills with cross-functional teams, supplier coordination, and quality assurance experience are required. Proficiency in maintaining design documentation, BOMs, change management, exposure to mechatronic systems, simulation tools for steering dynamics, and understanding of functional safety standards like ISO 26262 are necessary. Experience in Agile or model-based development environments, cost optimization, design-to-manufacture principles, supplier audits, and product development processes is beneficial. Additionally, exposure to steer-by-wire technologies and PLM tools like Windchill, OAS, Enovia, and Teamcenter would be advantageous. Strong presentation and technical documentation skills are also desired for this role.,

As an experienced professional with over 3 years of experience in Computer System Validation (CSV) and IT quality assurance within regulated industries such as pharmaceuticals, biotechnology, or medical devices, you will be responsible for developing, executing, and documenting CSV protocols and reports for both new and existing computer systems and software applications. Conducting risk assessments and gap analyses will be a key part of your role to identify potential quality issues and implement necessary corrective actions. Your responsibilities will also include developing and maintaining quality documentation, such as Standard Operating Procedures (SOPs), validation plans, test cases, and reports. You will actively participate in the selection, implementation, and qualification of new IT systems and software, while providing training and guidance to users on CSV and IT quality best practices. Collaboration with cross-functional teams, including IT, engineering, and manufacturing, will be essential to ensure compliance with regulatory requirements. Staying informed about industry best practices and regulatory changes related to CSV and IT quality will be crucial in this role. Additionally, you will be involved in performing internal audits and supporting external audits related to CSV and IT quality. To be successful in this position, you should hold a Bachelor's degree in a related field and possess a deep understanding of GxP regulations, such as 21 CFR Part 11 and Annex 11, along with industry best practices for CSV. Experience with software development lifecycle (SDLC) methodologies and quality management systems (QMS) is required. Excellent written and verbal communication skills are essential, as you will be expected to effectively communicate technical information to both technical and non-technical audiences. Strong analytical and problem-solving skills are also important for this role. The ability to work independently as well as part of a team is necessary to excel in this position. If you meet these qualifications and are interested in this opportunity, please share your updated resume with ruchita.parsekar@e-stonetech.com.,

As an experienced professional with over 3 years of experience in Computer Systems Validation (CSV) and IT quality assurance within regulated industries such as pharmaceuticals, biotechnology, and medical devices, you will be responsible for the following key tasks: - Developing, executing, and documenting CSV protocols and reports for both new and existing computer systems and software applications. - Conducting risk assessments and gap analyses to identify potential quality issues and implementing corrective actions as necessary. - Developing and maintaining quality documentation including Standard Operating Procedures (SOPs), validation plans, test cases, and reports. - Participating in the selection, implementation, and qualification of new IT systems and software. - Providing training and guidance to users on CSV and IT quality best practices. - Collaborating with cross-functional teams (e.g., IT, engineering, manufacturing) to ensure compliance with regulatory requirements. - Staying updated on industry best practices and regulatory changes related to CSV and IT quality. - Performing internal audits and supporting external audits related to CSV and IT quality. To be successful in this role, you should possess the following qualifications: - A Bachelor's degree in a related field. - 3-4 years of experience in CSV and IT quality assurance within regulated industries. - Strong understanding of GxP regulations such as 21 CFR Part 11, Annex 11, and industry best practices for CSV. - Experience with Software Development Lifecycle (SDLC) methodologies and Quality Management Systems (QMS). - Excellent written and verbal communication skills, with the ability to effectively communicate technical information to both technical and non-technical audiences. - Strong analytical and problem-solving skills. - Ability to work both independently and as part of a team. If you meet the qualifications and are looking for a challenging opportunity to further develop your skills in CSV and IT quality assurance, we encourage you to share your updated resume with us at ruchita.parsekar@e-stonetech.com.,

ABOUT THE ROLE Role Description: We seek a skilled Sr. Associate Validation Analyst to oversee and manage validation activities for AI platforms and solutions. As a key contributor, you will collaborate closely with cross-functional teams to ensure that the AI products follow the required validation processes, documentation, and comply with Amgen s standard operating procedures, policies, and guidelines. Your expertise will be instrumental in ensuring quality and adherence to required standards so that the engineering teams can build and deploy products that are compliant. Roles Responsibilities: Plan, coordinate, and lead the execution of validation and change control activities, including qualification and validation of AI products and platforms. Develop, review, and approve validation documentation such as Validation Plans, Validation Protocols (IQ/OQ), and Validation Reports. Ensure validation strategies meet regulatory requirements and company standards. Write, review, and approve Installation Qualification (IQ), Operational Qualification (OQ), and Computer System Validation documents. Stay updated on relevant changes to Amgen s SOPs and ensure validation practices are aligned with evolving standards. Collaborate with cross-functional teams, including quality assurance, system owners, business owners, RunOps, engineering, and platform teams to drive validation activities and meet project deadlines. Track the progress of validation activities and work closely with the product owner and scrum master to ensure validation activities timelines are aligned with the overall project plan. Ensure timely and effective completion of all validation activities in line with project objectives and schedules. Ensure proper documentation of validation activities, including deviations, change control, and non-conformance management. Identify opportunities for process improvements in validation activities. Stay current on new technologies, validation trends, and industry best practices to improve validation efficiencies. Functional Skills: Must-Have Skills: 5 or more years of experience in validation in a GXP-regulated environment (pharmaceutical, biotech, medical devices, etc. ). Proficiency in developing and executing validation protocols (IQ, OQ, PQ), reports, and related documentation. Familiarity with computer system validation and software validation is a plus. Strong problem-solving and analytical skills. Excellent communication and teamwork skills. Education and Professional Certifications Master s degree and 2 years of Information Systems experience, OR Bachelor s degree and 4 years of Information Systems experience Soft Skills: Excellent analytical and troubleshooting skills. Strong verbal and written communication skills Ability to work effectively with global, virtual teams High degree of initiative and self-motivation. Team-oriented, with a focus on achieving team goals. Ability to learn quickly, be organized and detail oriented. Strong presentation and public speaking skills. EQUAL OPPORTUNITY STATEMENT Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status. We will ensure that individuals with disabilities are provided with reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request an accommodation. .