Mechatronics Engineer

Quality Associate I

QE Specialist

Quality Engineer

Associate, Quality Assurance (QMS)

QC Laboratory Manager

Senior QA Automation Engineer

Continuous Improvement Lead

Associate Consultant

Senior Devops Engineer

Role Description: <ul><li>The Position has been created to lead a team of Mechanical Designers, Electrical Automation Engineers and Technicians of the Operations team to define the process and build the machines needed to make the new products in line with the strategy map and market demand.</li></ul> Responsibilities: <ul><li>Responsible for working with a team of engineers for new project launches. Coordination with different technology leads connected with new projects. Collaborating with ME, OPS, AQE, NPI and PLTL team for execution of all new projects as per agreed APQP timelines.</li><li>Responsible for execution of PLTL projects and adherence to launch sheet requirements.</li><li>End to End responsible for capturing the voice of Customers and All Stakeholder requirements of the product to meet the expectations</li><li>Act as a purposeful bridge between ME and operations.</li><li>Work closely with project management and NPI procurement for capacity and streamlined supplies&nbsp;</li><li>Identify safety, quality and cost saving opportunities on new and existing projects.</li></ul> Requirements: <ul><li>Technical Degree/Diploma in Mechatronics - NTTF/BE</li><li>Hands own experience assembly of machines and troubleshooting</li><li>1 to 4+ years of experience working in medium or large matrix organizations.&nbsp;</li><li>Hands on Experience in designing and building Complex and high precision machines, high accuracy assembly automation machines for Automotive or electronics industries</li><li>Experience in Robot programming.</li><li>Vision inspection and testing machines like leakage testers and electrical testers experience&nbsp;</li><li>PLC and HMI Programming, Servo programming and tuning, and trouble shooting</li><li>Updated knowledge on current Programming Software and Design Software.</li></ul>

Responsibilities: <ul><li>Provide daily quality oversight during manufacturing, warehousing, and qualification activities, including but not limited to line clearance and AQL sampling.</li><li>Ensure adherence to cGMP, SOPs, and regulatory standards.</li><li>Lead and execute QA review of batch records, logbooks, and related GMP documentation to support timely and accurate product disposition.</li><li>Develop, implement, and maintain site-specific quality procedures (SOPs, work instructions, forms) governing QA support responsibilities</li><li>Ensure proper execution of Good Documentation Practices (GDP)and data integrity in all manufacturing executed records.</li><li>Take active role in preparing the site for regulatory inspection.</li><li>Act as a QA representative during regulatory inspections, internal audits, and customer audits.</li><li>Contribute to the inspection readiness of the site, including periodic walkthroughs and risk-based quality improvements.</li></ul> Requirements: Qualifications / Experience <ul><li>Bachelor’s degree in a scientific or technical discipline (e.g., Biology, Chemistry, Pharmacy, Engineering).</li><li>5+ years of experience in pharmaceutical manufacturing, or QA.</li><li>Familiarity with aseptic manufacturing, sterile injectable processes, and cleanroom environments.</li><li>Knowledge of FDA cGMPs, ICH Q8-Q10 guidelines, EU Annex 1, and risk-based qualification approaches.</li><li>Experience supporting regulatory inspections and validation documentation reviews.</li></ul> Skills / Competencies <ul><li>Strong knowledge of 21 CFR part 10, and 211.</li><li>Strong knowledge of aseptic GMP manufacturing and QA shopfloor support.</li><li>Excellent organizational and communication skills with high attention to detail.</li><li>Ability to work collaboratively with operations, and engineering.</li><li>Commitment to data integrity, continuous improvement, and patient safety.</li></ul>

Responsibilities: <ul><li>Provide real-time QA oversight on the production floor, in warehouse areas, and during qualification activities.</li><li>Perform batch record and logbook review, ensuring accuracy, completeness, and compliance with GDP standards.</li><li>Execute and document line clearance and room readiness inspections prior to manufacturing activities.</li><li>Review qualification and validation protocols for clarity, compliance, and alignment with regulatory and internal quality expectations.</li><li>Support execution of qualification protocols by providing on-site quality presence during testing and ensuring deviations are properly documented and escalated. 6.	Initiate, investigate, and support closure of deviations, non-conformances, and CAPAs related to manufacturing and qualification activities.</li><li>Collaborate with cross-functional teams to ensure timely and compliant execution of commissioning, qualification, and validation activities.</li><li>Support the development and maintenance of site-specific quality procedures (SOPs, work instructions, forms) governing manufacturing, warehousing, engineering, maintenance, and validation operations.</li><li>Review and approve site procedures to ensure clarity and compliance with cGMP standards.</li><li>Maintain awareness of site policies, cGMP regulations, and evolving regulatory expectations applicable to sterile injectable operations.</li><li>Participate in internal walkthroughs, audit preparations, and readiness activities for regulatory inspections.</li><li>Support the implementation of continuous improvement initiatives and site quality metrics.</li></ul> Requirements: Qualifications/Experience <ul><li>Bachelor’s degree in a scientific, engineering, or technical discipline (e.g., Biology, Chemistry, Pharmacy, Engineering)</li><li>2–5 years of experience in quality assurance, manufacturing, or validation in a cGMP-regulated pharmaceutical or biotech manufacturing environment</li><li>Working knowledge of FDA, EU, and ICH guidelines related to sterile manufacturing, validation, and data integrity</li><li>Experience supporting commissioning and qualification activities is strongly preferred</li><li>Familiarity with GDP, batch record review, and deviation documentation processes</li></ul> Skills/Competencies <ul><li>Strong attention to detail and commitment to compliance</li><li>Solid written and verbal communication skills</li><li>Ability to work collaboratively across departments in a fast-paced environment</li><li>Comfortable supporting shop-floor activities and cross-functional execution teams</li><li>Proficient in using quality systems and document management tools</li><li>Flexible and adaptable to changing priorities and evolving project timelines</li><li>Commitment to data integrity, continuous improvement, and patient safety</li></ul>

Responsibilities: <ul><li>Act as technical expert and provide QA support during facility, utility, manufacturing equipment, and laboratory instrument qualification by reviewing qualification and validation protocols for clarity, compliance, and alignment with regulatory and internal quality expectations. Collaborate with cross-functional teams to ensure timely and compliant execution of commissioning, qualification, and validation activities</li><li>Review and approve qualification protocols and final reports (equipment, utilities, facilities, processes) to ensure alignment with quality and regulatory standards.</li><li>Support execution of qualification protocols by providing on-site quality presence during testing and ensuring deviations are properly documented and escalated</li><li>Provide QA support during technical transfer and process validation of new products.</li><li>Provide support to operation during Change Control and Deviation process. Drive timely and compliant resolution of deviations, non-conformances, and CAPAs arising during operations and qualification activities. </li><li>Support the development and maintenance of site-specific quality procedures (SOPs, work instructions, forms) governing manufacturing, warehousing, engineering, maintenance, and validation operations.</li><li>Maintain awareness of site policies, cGMP regulations, and evolving regulatory expectations applicable to sterile injectable operations.</li><li>Provide QA support during regulatory inspection. Participate in internal walkthroughs and audit. &nbsp;</li><li>Prepare quality and compliance metrics to support continuous improvements</li></ul> Requirements: Qualifications/Experience <ul><li>Bachelor’s degree in a scientific, engineering, or technical discipline (e.g., Biology, Chemistry, Pharmacy, Engineering)</li><li>Minimum of 7-10 years of experience in quality assurance, manufacturing, or validation in a cGMP-regulated pharmaceutical or biotech manufacturing environment</li><li>Working knowledge of FDA, EU, and ICH guidelines related to sterile manufacturing, validation, and data integrity</li><li>Experience supporting commissioning and qualification activities </li><li>Ability to work collaboratively with operations, engineering, and validation stakeholders</li></ul> Skills/Competencies <ul><li>Strong attention to detail and commitment to compliance</li><li>Solid written and verbal communication skills</li><li>Ability to work collaboratively across departments in a fast-paced environment</li><li>&nbsp;Strong knowledge of validation principles and qualification documentation </li><li>Proficient in using quality systems and document management tools</li><li>Flexible and adaptable to changing priorities and evolving project timelines</li><li>Commitment to data integrity, continuous improvement, and patient safety</li></ul>

Role Description: <ul><li>The Entry-Level Associate, Quality Assurance supports the Quality Management System (QMS) and documentation processes at the Chestnut Ridge site.</li><li>This role is designed for individuals beginning their career in pharmaceutical quality assurance and provides hands-on experience in maintaining compliance and supporting documentation workflows in a regulated environment.</li></ul> Responsibilities: <ul><li>Assist in organizing and maintaining QMS documentation including SOPs, CAPAs, deviations, and complaints.</li><li>Support the preparation and tracking of quality metrics and trending reports.</li><li>Help coordinate internal audits and document audit responses.</li><li>Participate in documenting product quality complaints and adverse event records.</li><li>Aid in digitizing logbooks and checklists using electronic systems.</li><li>Collaborate with cross-functional teams to ensure timely and accurate documentation updates.</li><li>Provide administrative support for change control processes and quality-related meetings.</li><li>Assist in preparing documentation for regulatory inspections and external audits.</li><li>Maintain document control systems and ensure timely review and archival of QA records.</li><li>Support training documentation and tracking for QA-related procedures.</li><li>Help with data entry and analysis for quality reports using basic statistical tools.</li><li>Monitor document lifecycle and ensure version control compliance.</li><li>Participate in continuous improvement initiatives related to documentation and QMS processes.</li></ul> Requirements: Education &amp; Experience <ul><li>Required Education: Bachelor’s degree in Pharmaceutical Sciences or a related field.</li><li>Preferred Education: Master’s degree is a plus.</li><li>Experience: 1–3 years in a pharmaceutical or regulated industry (internships or co-op experience acceptable).</li><li>Tools/Technologies: Familiarity with QMS platforms and electronic documentation systems preferred.</li></ul> Physical Requirements <ul><li>On-site role at Chestnut Ridge, NY.</li><li>Standard work hours: 8 AM to 5 PM.</li><li>No travel required.</li><li>No lifting or driving responsibilities.</li></ul>

Responsibilities: <ul><li>Establish and lead the QC laboratory, including analytical and microbiological functions, supporting sterile injectable IV bag production.</li><li>Oversee all testing activities: raw material, in-process, finished product, and stability testing, in compliance with applicable cGMP and regulatory requirements.</li><li>Support and manage startup, qualification, calibration, and maintenance of all QC lab equipment and systems to ensure operational readiness and regulatory compliance.</li><li>Develop and enforce strong data integrity practices, including procedures, training, and routine monitoring of laboratory systems and documentation.</li><li>Build and maintain a scientifically sound, compliant laboratory environment capable of supporting high-potent APIs and controlled substances.</li><li>Hire, train, and mentor laboratory personnel to ensure technical capability and compliance with laboratory and safety procedures.</li><li>Implement and maintain robust systems for documentation (SOPs, protocols, specifications), investigations (OOS, deviations), and CAPA management.</li><li>Lead and support analytical method transfers, validations, and technical investigations in collaboration with cross-functional teams.</li><li>Oversee microbiology operations, including environmental monitoring, utility sampling, sterility testing, and microbiological release activities.</li><li>Ensure inspection readiness and represent QC in audits, PAIs, and regulatory inspections.</li><li>Collaborate cross-functionally with QA, Validation, Engineering, Manufacturing, and Regulatory to ensure alignment and compliance across the site.</li><li>Ensure adherence to safety protocols, especially in handling high-potent materials and controlled substances.</li><li>Establish laboratory KPIs and drive continuous improvement in performance, compliance, and operational efficiency.</li></ul> Requrements: Qualifications / Experience: <ul><li>Bachelor’s or Master’s degree in Chemistry, Microbiology, or related scientific discipline.</li><li>8–12 years of pharmaceutical QC laboratory experience, including 3–5 years in a leadership role.</li><li>Experience with sterile injectable manufacturing, high-potent APIs, and controlled substances is required.</li><li>Deep knowledge of cGMP, FDA, ICH, USP, and applicable global regulatory standards.</li><li>Experience with startup or greenfield sites and laboratory buildouts preferred.</li><li>Demonstrated experience with method transfer, validation, and technical problem-solving.</li><li>Experience establishing equipment lifecycle programs, including qualification and maintenance.</li></ul> Skills / Competencies: <ul><li>Strong leadership with ability to build and develop high-performing lab teams.</li><li>Excellent technical knowledge in analytical and microbiological testing.</li><li>Deep understanding of data integrity principles and enforcement of best practices.</li><li>Proficiency in laboratory systems (LIMS, CDS, ELN) and equipment qualification.</li><li>Ability to manage complex lab operations in a startup environment.</li><li>Strong project management, documentation, and communication skills.</li><li>Commitment to patient safety, quality, and regulatory compliance.</li></ul>

Responsibilities: <ul><li>Together with the team of developers handle the product quality.</li><li>Lead and manage the automation testing efforts and deliverables.</li><li>Plan and prioritize testing activities.</li><li>Maintain and improve an existing test automation framework.</li><li>Develop automation tests for API and UI.</li><li>Execute, maintain and update automation tests.</li><li>Review and analyze tests execution results.</li><li>Maintain all related test documentation.</li><li>Prepare testing data.</li><li>Proactively acquire and clarify requirements as necessary.</li><li>Mentor less skilled teammates and newcomers.</li></ul> Requirements: <ul><li>Strong knowledge of OOP (understanding OOP in automation).</li><li>Excellent knowledge of automation testing principles.</li><li>Excellent knowledge of web-based application structure.</li><li>Excellent knowledge of Python programming language.</li><li>Expert in REST API testing.</li><li>Experience in UI testing.</li><li>Wide experience in developing automation testing frameworks.</li></ul>

Responsibilities: Program Development &amp; Strategy: <ul><li>Design and implement a holistic Continuous Improvement framework tailored to the Talent Hub’s global operations which enhances the existing foundation</li><li>Define revised vision, roadmap, and priorities aligned with business goals and transformation initiatives</li><li>Ensure that Lean principles, a CI mindset and agility are embedded into the DNA of the Talent Hub to drive performance and cost efficiency.</li></ul> Culture &amp; Capability Building: <ul><li>CI mindset across all functions and teams within the AUT Talent Hub including Integrated Service Excellence &amp; Business Analytics.</li><li>Develop and deliver in collaboration with the our client Practitioners and Experts training programs, workshops/Kaizen Events as well as coaching to build strong CI capabilities.</li></ul> Requirements: <ul><li>MBA with focus on Supply Chain, Operations or Quality from a Tier-1 Institute (like IIMs/ IITs/ NITs/ Nittie/ SP Jain, etc.)</li><li>3-5 years of work experience in Supply Chain, Operations or Continuous Improvement roles&nbsp;</li><li>Proven experience with Lean principles</li><li>Certification in Lean, Six Sigma or similar preferred</li><li>Excellent communication and stakeholder engagement skills.</li><li>Strong analytical, facilitation and change management skills&nbsp;</li><li>Experience in global/matrixed environments</li><li>Very deep knowledge on Supply Chain Management Processes</li></ul>

Role Description: <ul><li>We are looking for Associate Consultants to join a major Platform Operations workstream in Bangalore.</li><li>The focus will be on enabling and assisting the Customer Platform Operations team to manage and operate a newly deployed Red Hat OpenShift Virtualization (OCP Virt) platform in a production environment.</li><li>The consultants will be embedded in the Platform Operation Track, working side-by-side with the customer team to provide operational support, knowledge transfer, and daily assistance with Day 2 tasks.</li></ul> Responsibilities:&nbsp; <ul><li>Support the deployment, operation, and management of the Red Hat OpenShift Virtualization platform in production.</li><li>Assist the Customer Ops team with daily operational tasks and troubleshooting.</li><li>Enable the Ops team to: o Resolve minor issues independently (requiring strong OCP/OCP Virt knowledge).</li><li>Correctly identify significant issues and escalate support cases with the necessary details for fast resolution.</li><li>Share best practices, operational guidelines, and documentation to strengthen the Ops team’s capabilities.</li><li>Contribute to the long-term stability and scalability of the platform.</li></ul> Requirements: Required Skills &amp; Experience&nbsp; <ul><li>Strong, hands-on experience with Red Hat OpenShift and OpenShift Virtualization (OCP Virt).</li><li>Good understanding of containerized environments, Kubernetes, and platform operations.</li><li>Ability to provide operational support and knowledge transfer to customer teams.</li><li>Strong problem-solving skills and familiarity with Day 2 operational tasks.</li><li>Good communication skills to work effectively in customer-facing, collaborative environments.</li></ul>

Responsibilities: You will make an impact in the following way: Advanced Troubleshooting:&nbsp; <ul><li>Diagnose and resolve complex issues related to the cloud application, involving in-depth of the application architecture and infrastructure.</li></ul> Root Cause Analysis:&nbsp; <ul><li>Conduct thorough root cause analyses for recurring issues, implement preventive measures, and provide insights for continuous improvement.</li></ul> Automation and Scripting:&nbsp; <ul><li>Develop and utilize scripts and automation tools to streamline processes, improve efficiency, and reduce manual intervention in issue resolution.</li></ul> Documentation:&nbsp; <ul><li>Maintain comprehensive documentation for troubleshooting procedures, system configurations, and resolutions to facilitate sharing and future reference.</li></ul> Customer Communication:&nbsp; <ul><li>Effectively communicate with customers, providing clear and timely updates on issue resolution progress and collaborating on preventive measures.</li><li>You will be responsible for High Performance, Scalable, Robust, and Secure Common SaaS Framework based on AWS/OCP infrastructure.&nbsp;</li><li>This framework allows customers to configure provision, upgrade &amp; monitor various network functions in carrier grade enterprise &amp; telecom networks.&nbsp;</li></ul> Security and Compliance:&nbsp; <ul><li>Ensure the security of systems and applications, adhere to compliance requirements, and implement best practices for data protection.</li></ul> Collaboration:&nbsp; <ul><li>Collaboration with internal and external stakeholders.&nbsp;</li><li>Work closely with development, QA, and operations teams to foster a culture of collaboration and continuous improvement.&nbsp;</li><li>Collaborate with client’s team to gather the requirements.</li></ul> Training and Mentorship:&nbsp; <ul><li>Provide guidance and mentorship to junior team members and promote sharing within the organization.</li><li>Troubleshoot and fix any customer issues identified internally or in the production deployments.</li></ul> Requirements: <ul><li>5-8 years of Experience in DevOps (Jenkins, AWS services, Kafka, Grafana, elastic search, Bitbucket, Git, Deployment, Documentation, Root Cause Analysis reports, Customer interactions etc)</li><li>Experience with Cloud-native SaaS development &amp; virtualization technologies, for example, AWS, ESXi, KVM, HyperV would be a plus.&nbsp;</li><li>Extensive experience in developing distributed system design.</li><li>Prefer experience with microservice architecture, large scale, public cloud, IAM</li><li>Strong knowledge of containerization technologies like Kubernetes and Docker.&nbsp;</li><li>Strong knowledge in public cloud technologies (preferably AWS) and on-premises setups.</li><li>Good knowledge of analysing backend, frontend code whenever required and able to perform some tests as per customer issues.</li><li>Experience with CI/CD tooling like Jenkins etc.</li><li>Experience with version control system like Git, Bitbucket.</li><li>Experience with IaaC (Infrastructure as a Code) tools like Terraform.</li><li>Familiarity with agile development methodologies.&nbsp;</li><li>Lead and participate in various scrum ceremonies.</li><li>Good knowledge of observability tools like Kibana, Elastic stack, Prometheus stack etc.</li><li>Good knowledge of Linux operating system</li><li>Good knowledge of programming languages like Shell scripting, Python etc.</li><li>Knowledge of REST API, API gateways&nbsp;</li><li>Effective communication skills – written, spoken, listening and presentation.&nbsp;</li><li>Great Team player and experience working with global teams and global organizations.&nbsp;</li><li>Bachelor’s in computer science or equivalent.&nbsp;</li><li>Preferably a master’s degree in computer science.</li></ul>

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17 embedded qa Jobs found

Mechatronics Engineer

Quality Associate I

QE Specialist

Quality Engineer

Associate, Quality Assurance (QMS)

QC Laboratory Manager

Senior QA Automation Engineer

Continuous Improvement Lead

Associate Consultant

Senior Devops Engineer

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Skills

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Jobtitle

17 embedded qa Jobs found

Mechatronics Engineer

Quality Associate I

QE Specialist

Quality Engineer

Associate, Quality Assurance (QMS)

QC Laboratory Manager

Senior QA Automation Engineer

Continuous Improvement Lead

Associate Consultant

Senior Devops Engineer

WhiteCrow WhiteCrow is on a mission to connect companies with the best talent across the globe.

EMPLOYER

TALENT

COMPANY

Contact Us

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WhiteCrow
WhiteCrow is on a mission to connect companies with the best talent across the globe.