Senior Quality & Reliability Engineer

Senior Project Management Engineer

Manufacturing Manager / Staff Engineer - Cable Making

QE Specialist

Supv III Customer Service

Environmental Health and Safety (EHS) Manager

Supply Chain Business Process Expert

Senior Electrical Engineer

HR Business Partner IV

Product Manager / Senior Product Manager (Hospital & Oncology)

Responsibilities: Quality System &amp; Compliance <ul><li>Develop and implement quality and reliability processes to support NPI.</li><li>Lead the development and scaling of the site Quality Management System (QMS).</li><li>Ensure QMS elements (management reviews, internal audits, supplier management) comply with global standards.</li><li>Act as Lead Auditor for internal audits and ensure compliance with ISO 13485 and FDA QSR.</li><li>Support external audits, including preparation, mock audits, and corrective actions.</li><li>Review and approve ECOs, DCOs, training matrices, and other NPI documentation.</li><li>Maintain updated quality policies and procedures aligned with evolving standards.</li></ul> NPI Planning &amp; Execution <ul><li>Represent Quality in customer meetings and business reviews.</li><li>Collaborate with cross-functional teams including engineering, manufacturing, PMO, and supply chain.</li><li>Support implementation of electronic quality systems for improved traceability and documentation.</li><li>Evaluate product development objectives to identify quality improvement opportunities.</li><li>Create, review, and maintain quality system documents specific to NPI.</li><li>Calculate and present NPI quality KPIs.</li></ul> Continuous Improvement &amp; Problem Solving <ul><li>Lead or support quality system improvement projects.</li><li>Use statistical and scientific methods to analyze data and drive improvements.</li><li>Provide expertise in CAPA, root cause analysis, and reliability engineering tools.</li><li>Facilitate cross-functional improvement teams focused on NPI processes.</li></ul> Training &amp; Leadership <ul><li>Conduct training in GDP, GMP, CAPA, and compliance topics.</li><li>Oversee CAPA investigations to ensure true root cause identification and effective corrective actions.</li><li>Supervise and mentor Quality Engineers supporting NPI initiatives.</li></ul> Requirements: Required Skills &amp; Competencies Core Competencies <ul><li>Strong technical learning ability</li><li>Excellent problem-solving and analytical thinking</li><li>High ethical standards and integrity</li><li>Action-oriented and self-driven</li></ul> Job-Specific Skills <ul><li>Knowledge of NCMRs, CARs, CAPA, customer complaints, RMA metrics, DPPM, and DLPM</li><li>Strong technical "hands-on" skills</li><li>Excellent communication and interpersonal abilities</li><li>Ability to manage multiple tasks in a fast-paced environment</li><li>Strong prioritization and organizational skills</li><li>Proficiency in Microsoft Office (Word, Excel, PowerPoint, Visio)</li><li>Advanced technical report writing skills</li><li>Strong understanding of ISO 13485 and FDA QSR</li><li>Bilingual English (Advanced) / Spanish preferred</li><li>Willingness to travel up to 20% (based in Costa Rica)</li></ul> Experience &amp; Education <ul><li>Experience: 5+ years of Quality leadership experience in a manufacturing environment, preferably in multinational settings and NPI roles.</li><li>Education: Bachelor’s degree in a scientific or engineering discipline.</li><li>Certifications: CQE/CSSBB certification preferred.</li></ul>

Responsibilities: Project Timeline: <ul><li>Identify and align projects goals and scope with PJM and PM, and breakdown tasks of tooling/process developments and qualification</li><li>Make/align tooling development and qualification timeline, assign tasks to Ops team include tooling development, materials purchase</li><li>Track and manage core team to execute project progress based on committed project schedule</li></ul> Project Cost: <ul><li>Lead Ops to simulate sample cost and production cost to achieve project landing zone target, lead Ops to optimize launch cost to the best</li><li>Budget and control scrap cost though leverage design and manufacturing process to meet project target during NPI phase</li></ul> Project Execution: <ul><li>Guide capacity planning, materials sourcing and manpower to support all builds in the plant.</li><li>Oversee the progression of tooling/process development, identify bottleneck and issues, organize Ops team to improve those bottleneck and issues.</li><li>Oversee risks assessment in project execution, stay interlock with PJM to make multigation plan and conduct the planned activities in Ops.</li><li>Finalize the Safe Launch plan for the appropriate mix of product, tool capability and demand with the approval of the PjM, Quality, MDPE, and PjE. a. Lead Safe Launch team meetings to assure successful HVM startup and manufacturing process qualification for attainment of required metrics for successful G5 handoff.</li><li>Align the budget with Ops team with the tooling list provided by MPDE-A, control total capital spending against CER.</li><li>Lead and coordinate line setup to conduct LVM sample builds and coordinate HVM tool builds.</li><li>Lead Ops to make ramp up plan, include materials, operations and tool capacity ramp up, ensure manufacture team take over production control smoothly after G5.</li></ul> Product Sustaining: <ul><li>Product migration, as a receiving or sending leader to execute product move in or move out, including project timeline, investment, cost control, machine/material/manpower preparation, safety stock, safe launch, etc.</li><li>Lead product capacity analysis and expand it through re-investment per estimation.</li></ul> Requirements: <ul><li>Bachelor degree, engineering background is better</li><li>PMP certification preferred</li><li>At least 5 years related working experience in project management, 1~2 years experience in connector/cable/cable assembly is better</li></ul>

Responsibilities: Planning and Budgeting: <ul><li>Develop and implement section budget and plan, and monitor the achievement of the budget in order to achieve targeted department performance.</li><li>Policies and Procedures</li><li>Implement new global product development policies, procedures and systems, and maintain and develop local product development policies, procedures in order to meet company global requirements.</li></ul> People Management and Development: <ul><li>Allocate and balance the allocation of work across direct reports, review and provide timely performance feedback to direct reports, mentor, develop and motivate them, help resolve people/functional issues in the team in order to achieve targeted performance and retain key talent.</li></ul> Product Design Engineering (Cable Making): <ul><li>Review product data reports(including drawings, BOM, routine, costs), review and approve new product design engineering programme and ECN(Engineering Change Notice) control in the system in order to support new business development.</li><li>Lead new product and new technology development program in order to meet the potential market demand.</li></ul> Project Management (Cable Making): <ul><li>Approve cable making new project proposal and allocate project/resources to PM, review projects progress and provide cross function coordination, attend design review meeting, and review and approve the release of final design in order to ensure successful project implementation."</li></ul> Cable Making Manufacturing Engineering:	 <ul><li>Develop cable making advanced process technology, review cable making machine design, supervise of new product pilot run including SOP (Standard Operation Process),</li><li>review new sample making reports, and provide technical support to key process problem solving in order to effectively support production and new cable business development</li></ul> Requirements: <ul><li>Bachelor degree with engineering and sciences</li><li>8 years cable making working experience including 4 years management experience.</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>

Role Description: <ul><li>As a Manager in Solution Center, you will be at the forefront of driving transformational strategies focused on creating exceptional customer experiences.</li><li>Your leadership will be pivotal in establishing our brand as the preferred supplier by fostering strong customer relationships and steering your team towards unparalleled service excellence and growth.</li></ul> Responsibilities: <ul><li>Lead with Accountability: Spearhead your team to achieve specific departmental goals, focusing on delivering a superior Customer Experience.</li><li>Cultivate Customer Relationships: Empower your team to enhance and expand customer engagement.</li><li>Talent Acquisition and Development: Recruit and nurture top talent, building a team that embodies our vision and drives organizational transformation.</li><li>Champion of Change: Lead by example in adopting transformation initiatives and fostering a culture of positive change.</li><li>Operational Excellence: Instill a mindset of continuous improvement, enhancing team efficiency and service quality.</li><li>Career Development: Offer opportunities for team growth and development, preparing them for future career advancements.</li><li>Cross-Functional Collaboration: Work seamlessly with internal partners in different BU’s, engineering, planning, and sales to ensure comprehensive customer support.</li></ul> Requirements: <ul><li>Experience in a shared service environment.</li><li>Stake Holder management experience</li><li>Track record of successful change management in Customer Care.</li><li>Leadership experience in large, multi-layered teams.</li><li>8 + years in multinational Customer Care operations, with at least 5 years in a relevant role.</li><li>Effective collaboration across all organizational levels.</li><li>Industry-specific experience is advantageous.</li><li>Exceptional communication skills.</li></ul>

Responsibilites: <ul><li>Develop and implement site-wide EHS programs aligned with federal, state, and local regulations, including OSHA, EPA, and DEA requirements for controlled substances.</li><li>Lead risk assessments, job hazard analyses (JHAs), and containment evaluations, particularly in areas handling high-potent and controlled substances.</li><li>Serve as the primary liaison for EHS-related aspects of DEA compliance, supporting controlled substance handling protocols in collaboration with Quality, Security, and Operations.</li><li>Oversee the environmental and safety controls for controlled substances, ensuring proper ventilation, storage, access restrictions, spill response, and waste disposal procedures in compliance with DEA and EPA regulations.</li><li>Develop and maintain physical and procedural controls related to controlled substance areas (e.g., vaults, restricted labs, destruction processes) in partnership with Security and Regulatory Affairs.</li><li>Lead the investigation and root cause analysis of all incidents, near-misses, and controlled substance discrepancies, and implement corrective/preventive actions.</li><li>Ensure training and education of site personnel in EHS best practices, with a focus on potent compound safety, exposure monitoring, and controlled substance handling protocols.</li><li>Implement industrial hygiene programs, including monitoring of airborne concentrations and potential operator exposure to potent and hazardous compounds.</li><li>Establish robust programs for emergency preparedness, including chemical spills, fires, security threats, and controlled substance incidents.</li><li>Maintain all required permits, records, and documentation related to hazardous waste, emissions, safety incidents, and controlled substance EHS compliance.</li><li>Partner with Engineering, Validation, and Operations to incorporate EHS and security standards into facility, utility, and equipment design and commissioning.</li><li>Foster a strong culture of safety, accountability, and environmental stewardship at all levels of the organization.</li></ul> Requirements: <ul><li>Bachelor’s degree in Environmental Science, Occupational Health &amp; Safety, Chemical Engineering, or related field (Master’s preferred).</li><li>Minimum of 7–10 years of progressive EHS experience in a GMP-regulated pharmaceutical or biotechnology manufacturing environment.</li><li>Direct experience managing EHS compliance for controlled substances (DEA Schedules II–V) and high-potency APIs strongly preferred.</li><li>In-depth knowledge of OSHA, EPA, DEA, NJDEP, and global EHS regulations and guidelines.</li><li>Familiarity with industrial hygiene, containment technologies, and safe handling procedures for potent compounds</li><li>Experience leading EHS activities during greenfield/startup site development and qualification is a plus.</li></ul>

Role Description: <ul><li>As a member of our ISC Global Automotive team, you will focus on enhancing our S&amp;OE process and driving the successful implementation of SAP APO PP/DS or S4 ePPDS as well as SAP IBP in our manufacturing plants.</li><li>Leveraging your extensive experience with advanced planning software, you will help define business requirements, ensure system readiness, and guide local teams through adoption and optimization processes.</li></ul> Responsibilities: <ul><li>Drive initiatives in automation and advanced planning systems to enhance and refine S&amp;OE processes.</li><li>Lead cross-functional teams - including project managers, subject matter experts, and IT partners - in defining business requirements, designing.</li><li>Provide project updates to various stakeholders at different levels of the organization.</li><li>Focus on timely project completion, resource deployment, staying within budget and appropriate adoption by end users.</li><li>Develop comprehensive training materials for end users and deliver training sessions and champion best practices and contribute to the development of standardized processes</li></ul> Requirements: <ul><li>Master’s degree or equivalent in Supply Chain, Materials Management, Business, Logistics, Engineering, or related field.</li><li>5 years’ hands-on experience in supply chain and operations, ideally manufacturing planning.&nbsp;</li><li>Extensive user-side experience in SAP APO PP/DS or S4 ePPDS implementation (essential); experience with SAP IBP Response is highly desirable.</li><li>Proven ability to use and train others on APO PP/DS and/or S4 ePPDS tools.</li></ul>

Responsibilities: <ul><li>Meeting with the product engineers to determine product testing parameters.</li><li>Conducting quality assurance and designing performance tests using the new testing procedures.</li><li>Troubleshooting any errors and streamlining the testing procedures. Ensuring all tests and procedures meet company and industry standards.</li><li>Preparing test reports for management.</li></ul> Requirements: <ul><li>BS Degree in Engineering or Science, 5+ years’ experience related to primary job function, Electrical Engineering preferred.</li><li>Experience with software such as Altium, Ultiboard, Multisim, AutoCAD, Space Claim, Creo, and LabVIEW desirable.</li><li>Experience with solid state power switching highly desirable.</li><li>Familiarity with 270Vdc and 1000Vdc applications desirable.</li><li>Effective communication and presentation skills required.</li><li>Ability to maintain focus and complete tasks independently and on time.</li><li>This position requires access to information which is subject to stringent controls under the International Traffic in Arms Regulations (ITAR) or Export Administration Regulations (EAR). Candidates must be a U.S. citizen or national, U.S. lawful permanent resident, person granted asylee status in the U.S., or person admitted into the U.S. as a refugee.</li></ul>

Overview: <ul><li>The ICT business unit HRBP – Plant serves as a strategic business partner and trusted thought partner to Plant Leaders and in country senior Management.</li><li>This position is located on-site, but a hybrid work schedule will also be considered Serve as the HR site leader for the Tullahoma facility, acting as a trusted advisor to site leadership and aligning HR support with key business initiatives.</li></ul> Responsibilities: <ul><li>Partner with the broader HR network to deliver strategic talent solutions, organizational design, and effectiveness initiatives, fostering a One HR mindset.</li><li>Provide guidance on leadership development, succession planning, and talent pipeline strategies to support long term organizational growth.</li><li>Champion diversity, engagement, and inclusion efforts, with a global mindset and focus on creating equitable access to development and information.</li><li>Coach and support managers on performance, team effectiveness, and employee development to enhance leadership capability and culture.</li><li>Lead and resolve complex employee relations matters, ensuring legal compliance and a respectful, inclusive workplace.</li><li>Design and implement talent development initiatives including stretch assignments, mentoring, and targeted training programs.</li><li>Lead HR project management efforts related to workforce transitions, organizational change, and process improvement initiatives.</li><li>Collaborate with cross-functional partners to deliver high-impact HR initiatives, ensuring clear communication, risk management, and timely execution.</li><li>Develop and manage detailed project plans for HR initiatives, including milestones, communications, and risk mitigation strategies.</li></ul> Requirements: <ul><li>Bachelor’s or Master`s degree in business, Human Resource Management, Psychology, or any related field 10+ years of progressive, international, HR related experience; breadth of HR knowledge and skills in a variety of fields in international context, including Business Partner; Experience in a manufacturing and or operations environment is strongly preferred.</li><li>Executive level and leadership experience; Experience influencing without authority.</li><li>Ability to influence, lead and drive execution into the functions/region through close partnership and collaboration with the broader HR function Proved track record in Organization Design, Change Leadership, Talent Management, and Organizational Development Ability to multi-task and work efficiently in a fast-paced, international matrix organization.</li><li>Preferred: Experience supporting M&amp;A activities, including HR due diligence, integration planning, and workforce impact assessments.</li><li>Strong project management and organizational skills Fluent English language skills Has advanced knowledge of regional labor laws and obligations and uses this knowledge to advise management, especially in conflict situations Excellent interpersonal, negotiation, and communication Ability to travel up to 10%</li></ul>

Role Overview: <ul><li>The Product Manager / Senior Product Manager – Hospital &amp; Oncology will be responsible for driving strategic and operational marketing initiatives for the Hospital Care portfolio across the Malaysian market.&nbsp;</li><li>This role focuses on developing and executing brand strategies, launching new products, and expanding the business through data-driven insights and strong cross-functional collaboration. The incumbent will play a key role in ensuring successful brand performance, portfolio growth, and alignment with corporate objectives within the hospital and institutional healthcare segments.</li></ul> Responsibilities: Marketing Planning (40%) <ul><li>Lead the development and execution of brand strategies and marketing plans to achieve business objectives and ensure effective market penetration.</li><li>Formulate pre-launch preparedness and go-to-market strategies for new and existing hospital care products.</li><li>Design and implement initiatives to enhance field force effectiveness, including sample strategy, sales meetings, and other sales-related marketing activities.</li><li>Develop and manage the annual brand business plan, including strategic priorities, objectives, and budget allocation.</li><li>Optimize resource planning and allocation to address evolving market dynamics and competitive challenges.</li></ul> New Portfolio Exploration &amp; Business Development (35%): <ul><li>Conduct in-depth product and market analyses to forecast demand, patient flow, and revenue potential for new products.</li><li>Generate actionable market insights through data analysis and engagement with healthcare professionals (HCPs).</li><li>Develop robust business cases for potential new portfolio additions, encompassing both prescription and hospital-based products.</li><li>Present business proposals and feasibility assessments to principals and senior management for approval and alignment.</li></ul> Marketing Implementation (25%): <ul><li>Plan, coordinate, and execute marketing campaigns and customer engagement activities to support product launches and ongoing brand promotion.</li><li>Build and strengthen relationships with key stakeholders including KOLs, hospital administrators, and healthcare associations to enhance brand reputation and visibility.</li><li>Implement and manage KOL engagement strategies aligned with brand objectives.</li><li>Manage brand budgets effectively and ensure timely development and rollout of marketing and promotional materials.</li><li>Support Continuing Medical Education (CME) programs and conduct product training sessions for the sales and medical teams to ensure consistent brand messaging and clinical accuracy.</li></ul> Requirements: <ul><li>Bachelor’s degree in Science or a related field.</li><li>Minimum of 2–3 years of experience as a Product Manager in a multinational pharmaceutical company.</li><li>Prior experience in a generic pharmaceutical company (in sales or product management) is an added advantage.</li><li>Strong understanding of key healthcare channels including general practitioners, private hospitals, public hospitals, and retail pharmacies.</li><li>Proven track record in brand management, product launches, and marketing strategy execution within the hospital or institutional care segment.</li><li>Customer-oriented with excellent interpersonal and communication skills.</li><li>Demonstrated ability to work collaboratively within cross-functional teams.</li><li>Exposure to digital marketing initiatives and analytics-driven campaigns is preferred.</li><li>Highly detail-oriented, with strong problem-solving and analytical skills.</li><li>Excellent verbal, written, and presentation abilities.</li><li>Strategic thinker with a performance-driven approach.</li></ul>

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160 validation lead Jobs found

Senior Quality & Reliability Engineer

Senior Project Management Engineer

Manufacturing Manager / Staff Engineer - Cable Making

QE Specialist

Supv III Customer Service

Environmental Health and Safety (EHS) Manager

Supply Chain Business Process Expert

Senior Electrical Engineer

HR Business Partner IV

Product Manager / Senior Product Manager (Hospital & Oncology)

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160 validation lead Jobs found

Senior Quality & Reliability Engineer

Senior Project Management Engineer

Manufacturing Manager / Staff Engineer - Cable Making

QE Specialist

Supv III Customer Service

Environmental Health and Safety (EHS) Manager

Supply Chain Business Process Expert

Senior Electrical Engineer

HR Business Partner IV

Product Manager / Senior Product Manager (Hospital & Oncology)

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

EMPLOYER

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