Manager – ADL GMP

Reference Standard Coordinator

Senior Software Engineer

Principal Software Engineer

Field Service Engineer

Manufacturing Engineer

Project Management Engineer

Senior Manufacturing Engineer

Manufacturing Technician V (Senior Technician)

Supervisor III, Production

Role Description: <ul><li>The Manager –ADL, GM P is responsible for leading analytical development activities within a GMP-regulated environment, ensuring robust method development, validation, and transfer for pharmaceutical products.</li><li>This role plays a critical part in supporting product development, regulatory submissions, and commercial manufacturing by providing accurate and compliant analytical data.</li></ul> Responsibilities <ul><li>Lead and manage a team involved in method validation, method transfer, and postproduction studies (Freeze Thaw analysis, Photostability studies, Dilution studies, RLD Characterization, etc.) for 505b(2) and generic ANDAs.</li><li>Troubleshoot and resolve challenges during method validation and method transfer of new products from R&amp;D to manufacturing sites.</li><li>Support regulatory filings and respond to analytical function queries.</li><li>Ensure compliance with cGLP within the ADL GMP function.</li><li>Provide support during quality inspections by regulatory agencies at manufacturing plants.</li><li>Timely closure of LIR, NCR, CCN, CAPA and ensure implementation of corrective and preventive actions.</li><li>Ensure timely compliance with Pharmacopoeia updates.</li><li>Mentor, coach, and develop team members for task execution and personal growth.</li><li>Collaborate with external partners (CRO/CMO) for analytical testing execution.</li><li>Work cross-functionally with project management, regulatory affairs, formulation development, manufacturing, and quality control teams.</li></ul> Requirements: <ul><li>Education: Ph.D. OR MPharm.</li><li>Experience: 3–4 years of team handling experience.</li></ul> Skills Required: <ul><li>Strong knowledge of analytical method validation, method transfer, Pharmacopoeia compliance, cGLP, and documentation practices.</li><li>Sound understanding of analytical techniques with good learning agility.</li><li>Excellent technical writing and computer skills for data recording, protocol/report generation, and presentations.</li><li>Strong coordination, relationship management, and ability to work in multicultural teams.</li><li>Effective communication and team management skills.</li><li>Knowledge of latest quality and regulatory requirements.</li><li>Ability to delegate effectively and take autonomous decisions.</li><li>Critical thinking skills for problem-solving and decision making.</li></ul>

Responsibilities: Sample Management <ul><li>Performs QC reference standard/chromatographic column receipt, processing, distribution for testing and storage.</li><li>Performs QC reference standard reconciliation and disposal.</li><li>Tracks inventory of reference standards in the lab.</li><li>Uses laboratory software for reference standard, chromatographic column management.</li><li>Verifies accuracy of labeling/documentation provided with reference standards.</li><li>Informs QC Coordinator if chemical or reference standard is expired for removal from laboratory area.</li><li>Coordinates, with lab management, in-house qualification of reference standards. Submit samples to the appropriate lab groups for testing.</li><li>Create and maintain reports including quality data trending, informational spreadsheets, laboratory log spreadsheets.</li><li>Compile a list of necessary laboratory supplies specifically reference standards, contacting vendors to obtain quotes.</li><li>Uses the purchasing system to procure reference standards and laboratory supplies.</li><li>Provide status updates to QC management and other departments regarding the status of reference standard inventory.</li><li>Maintain a safe work environment by following standards and procedures and complying with legal regulations.</li></ul> Lab Equipment <ul><li>Maintains, operates equipment and instruments supporting reference standard processing.</li><li>Provides general laboratory support such as routine instrument cleaning/preventative. maintenance, reference standard/sample receiving, chemical inventory, document filing and housekeeping.</li><li>Works with internal resources to maintain lab in an optimal state. Cleans lab working surfaces and disposes of any excess chemicals, solutions, solvents, etc. in the special waste containers for each class of waste chemicals.</li><li>Under close supervision, learns to troubleshoot basic instrument problems.</li></ul> Investigations <ul><li>Escalates any trends/events to the QC Lab Manager.</li><li>Escalates any reference standard documentation issues to the QC Lab Manager.</li><li>With guidance, participates in OOS/OOT/NOE and other investigations.</li><li>Assists, as and when needed, scientists working in the laboratory.</li><li>May assist in drafting, editing, and reviewing SOPs.</li></ul> Training <ul><li>Maintains assigned training records current and in-compliance.</li><li>May assist in the training of laboratory staff.</li></ul> Compliance <ul><li>Performs assigned work in a timely and safe manner conforming to regulatory, company and compendiaI requirements within pharmaceutical manufacturing setting.</li><li>Documents accurately data generated in notebooks/worksheets/LIMS in compliance with SOPs.</li><li>Follows internal processes related to controlled substances.	continuous.</li></ul> Safety <ul><li>Follows EH&amp;S procedures to ensure a safe work environment.</li><li>Follows all applicable safety and standards guidelines, such as SOPs, cGMP, DEA regulations good documentation practice and/or MSDS.</li></ul> Requirements: Education &amp; Experience <ul><li>College graduate, preferably in a Science related field.</li><li>Laboratory experience related to sample management preferred.</li></ul> Knowledge <ul><li>Basic knowledge of reference standard/sample management in a laboratory environment.</li><li>Some knowledge of applicable safety and standards guidelines: SOP, cGMP, GLP, DEA regulations and/or MSDS.</li><li>Competency in Microsoft Office Suite.</li><li>Proficiency with computers.</li></ul> Skills &amp; Abilities <ul><li>Ability to display and analyze data in a logical manner.</li><li>Good verbal and written communication skills as well as good computer skills.</li><li>Attention to details and accurate record keeping.</li><li>Establish and maintain cooperative working relationships with others.</li><li>Solid organizational skills.</li><li>Ability to take initiative, set priorities and follow through on assignments.</li></ul> Physical Requirements	 <ul><li>Extended periods of sitting, standing, walking, reaching, climbing/balancing, kneeling/crouching/crawling, looking at monitor for extended periods, moderate noise levels and potential business travel. Work is in an FDA and DEA-regulated pharma lab environment with risk of exposure to various chemicals.</li><li>Must occasionally lift and/or move up to 15-25 lbs.</li><li>Ability to wear personal protective equipment, including respirators, gloves, etc.</li><li>Specific visions abilities are required by this job include close vision and color vision.</li><li>Ability to occasionally tolerate significant differences in temperature and/or humidity for short periods.</li></ul>

Role Description: <ul><li>Dive into the forefront of innovation with our Gateway Security team, where we scan massive volumes of email traffic for our customers! Our pioneering Email Platform pushes on the boundaries of what’s possible, leveraging the latest technologies and tooling in AWS.</li></ul> Responsibilities: <ul><li>Implement Jenkins pipelines with modern CI/CD workflows</li><li>Create properly tuned alerts and dashboards to effectively monitor infrastructure and service health in production</li><li>Champion and leverage Infrastructure as Code technologies as a way of life</li><li>Contribute strongly to cloud migration efforts, bringing more and more capabilities into our standard AWS infrastructure</li><li>Write scripts and automated tests to ensure the resilience and quality of Mimecast solutions</li><li>Innovate and champion improvements in QE and CI/CD processes and tools</li></ul> Requirements: Experience <ul><li>7+ years of experience in a complex, multi-disciplinary environment, delivering products within specific time-scales and engaging with multiple senior stakeholders</li><li>Transform Product requirements into features/enhancements working with architects, Product Management and cross teams</li><li>Deliver AWS based Java services through CI/CD and Infrastructure as code using Terraform</li><li>Deploy, Monitor and analyze AWS usage, providing recommendations for cost optimisations without compromising system performance and reliability</li><li>Refactor monolithic applications into a microservices/k8s architecture</li><li>Provide support during critical production incidents and implement preventive measures</li><li>Demonstratable expertise in Java development, with a strong command of Java 11 and above</li><li>Proven experience in designing, developing, and optimizing backend systems for data processing at scale within AWS</li><li>In-depth knowledge and hands-on experience with AWS services, such as; ALB, S3, ElastiCache, IAM, CloudWatch, DynamoDb, EKS</li><li>Knowledge and experience on Kubernetes is must</li><li>Experience in building scalable, distributed REST/HTTP-based microservices on hybrid cloud environments</li></ul>

Role Description: <ul><li>Dive into the forefront of innovation with our Gateway Security team, where we scan massive volumes of email traffic for our customers! Our pioneering Email Platform pushes on the boundaries of what’s possible, leveraging the latest technologies and tooling in AWS.</li></ul> Responsibilities: <ul><li>Deliver AWS based Java services through CI/CD and Infrastructure as code using Terraform.</li><li>Deploy, Monitor and analyze AWS usage, providing recommendations for cost optimisations without compromising system performance and reliability.</li><li>Refactor monolithic applications into a microservices/k8s architecture.</li><li>Provide support during critical production incidents and implement preventive measures.</li></ul> Requirements: <ul><li>10+ years of experience in a complex, multi-disciplinary environment, delivering products within specific time-scales and engaging with multiple senior stakeholders.</li><li>Transform Product requirements into features/enhancements working with architects, Product Management and cross teams.</li><li>Demonstratable expertise in Java development, with a strong command of Java 11 and above</li><li>Proven experience in designing, developing, and optimizing backend systems for data processing at scale within AWS.</li><li>In-depth knowledge and hands-on experience with AWS services, such as; ALB, S3, ElastiCache, IAM, CloudWatch, DynamoDb, EKS.</li><li>Knowledge and experience on Kubernetes is must.</li><li>Experience in building scalable, distributed REST/HTTP-based microservices on hybrid cloud environments.</li></ul>

Responsibilities: <ul><li>Work independently on our client vacuum valves installation, troubleshooting, problem solving, maintenance and repairing on site/internal workshop.</li><li>Responds to customer calls; analyzes, and troubleshoots problems via phone, remote session or at customer site.&nbsp;&nbsp;</li><li>On time and correctly report working activities and time duration with customer signature.</li><li>Keep good communication with customers at various levels (tool engineers, section managers etc.)</li><li>Liaise with customers and internal stakeholders relating to technical and service issues.</li><li>Conducting customer support meetings and ensuring regular communication with customers.</li><li>Follow up and feedback customer complaints.</li><li>Follow up customer open issues until it closed.</li><li>Response for our client quality information collection and quality problem report.</li><li>Provide technical problem solving and roots cause analysis report.</li><li>Ability to support customer for urgent request in weekend and holiday.&nbsp;&nbsp;&nbsp;</li><li>Assessing customers’ needs and advice the customers with regards to spare parts, preventive maintenance and retrofit possibilities.</li><li>Special projects and other duties as assigned.&nbsp;&nbsp;&nbsp;</li></ul> Requirements: <ul><li>Mechanical or electronic background with college degree or above.</li><li>Minimum 3 years of service experience in Cleanroom environment (Semiconductor or vacuum industry is preferred).</li><li>Strong skill of diagnosing, repairing and troubleshooting.</li><li>Strong business acumen and ability to identify opportunities within problems.</li><li>Be able to work independently under pressure and irregular hours.</li><li>Personal accountability, team player.</li><li>Good communication and interpersonal skill.</li><li>Goal achievement.</li><li>Willing and able to travel frequently within short notice. Be adapted to irregular over time work together with customer urgent need.</li><li>Able and comfortable to communicate in English, Chinese. And 1 other additional language is a plus. (Japanese or Korean).</li></ul>

Responsibilities: <ul><li>Develop, implement, and optimize manufacturing processes to improve efficiency, quality, and cost-effectiveness.</li><li>Provide technical support for new product introduction (NPI), including process design, tooling, and equipment validation.</li><li>Conduct root cause analysis and lead corrective/preventive actions (CAPA) to&nbsp;</li><li>resolve production issues.</li><li>Collaborate with cross-functional teams (R&amp;D, Quality, Supply Chain, Maintenance) to ensure smooth project execution and production readiness.</li><li>Prepare and maintain process documentation, work instructions, and training materials.</li><li>Monitor key production metrics (yield, scrap, cycle time, downtime) and implement continuous improvement initiatives.</li><li>Participate in lean manufacturing, Six Sigma, and Kaizen activities to drive operational excellence.</li><li>Ensure compliance with safety standards, environmental regulations, and ISO/IATF quality system requirements.</li><li>Support cost reduction projects through process improvement, automation, and supplier collaboration.</li></ul> Requirements: <ul><li>Bachelor’s degree in Mechanical Engineering, Manufacturing Engineering, Industrial Engineering, or related field.</li><li>3–5 years of relevant experience in manufacturing engineering; automotive or electronics industry experience preferred.</li><li>Strong knowledge of manufacturing processes such as machining, assembly, injection molding, stamping, or PCB assembly (depending on industry).</li><li>Familiarity with APQP, PPAP, FMEA, Control Plan, and other quality tools.</li><li>Proficiency in CAD software (e.g., AutoCAD, SolidWorks, Creo) and MS Office.</li><li>Hands-on experience with Lean Manufacturing and problem-solving methodologies (5Why, 8D, DMAIC).</li><li>Good communication and coordination skills; able to work in cross-functional and multicultural teams.</li><li>English: able to read and write technical documents; spoken English is a plus.</li></ul>

Responsibilities: <ul><li>Manage the overall project process, controlling schedule and quality to ensure timely delivery.</li><li>Develop project plans and set milestones during the initial stage.</li><li>Track progress of tasks, hold meetings when necessary, and drive team members to complete tasks efficiently.</li><li>Coordinate with procurement, cost, logistics, production staff, and suppliers to ensure smooth execution of project activities.</li><li>Review project budgets and costs; conduct tooling strategy meetings.</li><li>Identify alternative resources to reduce costs and make directional decisions based on project requirements.</li><li>Assess potential risks and arrange preventive actions to avoid them.</li></ul> Requirements: <ul><li>5–8 years of solid project management experience, especially with APQP and&nbsp;</li><li>PPAP quality knowledge and related project process management.</li><li>Age: under 40 years old.</li><li>Education: Bachelor’s degree (full-time) in engineering, preferably mechanical engineering or related fields.</li><li>Degrees in business administration, language, or arts will not be considered.</li><li>Work location: Building G1, No. 88 Dongchang Road, Suzhou Industrial Park (Suzhou 2.5 Industrial Park).</li></ul>

Responsibilities: <ul><li>Lead and support process improvement projects to optimize manufacturing efficiency, reduce waste, and improve quality</li><li>Develop, validate, and implement manufacturing processes and tooling for new and existing products</li><li>Collaborate with product development, quality, and production teams on new product introduction and design for manufacturability</li><li>Identify root causes of production issues and implement corrective and preventive actions</li><li>Lead Lean Six Sigma and 5S initiatives across the production floor</li><li>Support capacity planning and equipment layout optimization</li><li>Develop and maintain process documentation, work instructions, and standard operating procedures</li><li>Ensure compliance with safety standards, quality systems, and regulatory requirements</li><li>Mentor junior engineers and provide technical guidance to the operations team</li></ul> Requirements: <ul><li>Bachelor’s degree in mechanical engineering, Manufacturing Engineering, or a related field</li><li>Minimum 5 years of experience in a manufacturing or industrial engineering role, preferably in a high-mix, low-volume environment</li><li>Strong knowledge of Lean Manufacturing, Six Sigma, and process optimization techniques</li><li>Experience with manufacturing tools such as PFMEA, control plans, SPC, and root cause analysis</li><li>Proficient in CAD software and Microsoft Office applications</li><li>Excellent analytical, problem-solving, and communication skills</li><li>Ability to lead cross-functional teams and manage multiple projects</li><li>Experience in the electronics or connectivity components industry is an advantage</li></ul>

Responsibilities: <ul><li>Perform evaluations and/or analyze unique problems that are new to equipment.</li><li>Perform predictive maintenance by analyzing routine failures and determining adjustments and repairs that need to be made.</li><li>Perform training as needed to Lower level Maintenance Techs on troubleshooting and repair techniques utilized with equipment</li><li>Perform specified preventative maintenance on production equipment to prevent equipment downtime.</li><li>Monitor equipment operations to ensure proper usage.</li><li>Construct and/or assemble new equipment</li><li>Troubleshoot equipment failures and repair as needed</li><li>Perform specified preventative maintenance on production equipment to prevent equipment down-time</li><li>Perform Lock Out / Tag Out requirements.</li><li>Work from blueprints, manuals, sketches and verbal instructions.</li><li>Help repairing on hydraulic, pneumatic and electromechanical systems.</li><li>Perform other duties as assigned or necessary to meet business conditions or changes.</li><li>Adheres to quality and safety systems or maintenance of quality and safety standards.</li></ul> Requirements: <ul><li>High school diploma or equivalent</li><li>5+ years experience in injection molding maintenance or extrusion, or mechanical, hydraulic, pneumatic and electrical repair</li></ul>

Responsibilities: <ul><li>Supervise and lead production team members across assigned shifts and production lines.</li><li>Ensure daily production schedules are met in compliance with safety, quality, and delivery requirements.</li><li>Monitor key performance indicators (OEE, yield, scrap, downtime) and implement corrective actions as needed.</li><li>Drive continuous improvement initiatives in productivity, cost reduction, and process efficiency.</li><li>Partner with Manufacturing Engineering, Quality, and Maintenance teams to resolve process and equipment issues.</li><li>Provide training, coaching, and performance feedback to team members to build skill and capability.</li><li>Enforce compliance with EHS standards, company policies, and 5S/lean manufacturing practices.</li><li>Ensure proper manpower planning, shift scheduling, and attendance management.</li><li>Manage production documentation, reporting, and escalation of issues to management.</li><li>Support new product introduction (NPI) and ensure smooth handover to mass production.</li></ul> Requirements:﻿ <ul><li>Bachelor’s degree/diploma in Manufacturing, Mechanical, Industrial Engineering, or related field.</li><li>Minimum 5–7 years of production experience in high-volume manufacturing, with at least 3+ years in a supervisory/lead role.</li><li>Strong knowledge of lean manufacturing principles, problem-solving, and root cause analysis.</li><li>Good understanding of ISO/IATF 16949, EHS, and quality management systems.</li><li>Proven leadership, people management, and conflict resolution skills.</li><li>Ability to work in a fast-paced, 24/7 manufacturing environment with flexibility to support multiple shifts.</li></ul>

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54 preventive maintenance Jobs found

Manager – ADL GMP

Reference Standard Coordinator

Senior Software Engineer

Principal Software Engineer

Field Service Engineer

Manufacturing Engineer

Project Management Engineer

Senior Manufacturing Engineer

Manufacturing Technician V (Senior Technician)

Supervisor III, Production

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54 preventive maintenance Jobs found

Manager – ADL GMP

Reference Standard Coordinator

Senior Software Engineer

Principal Software Engineer

Field Service Engineer

Manufacturing Engineer

Project Management Engineer

Senior Manufacturing Engineer

Manufacturing Technician V (Senior Technician)

Supervisor III, Production

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.