Field Service Engineer

Process Mechanic – Sterile Filling & Packaging

Facility Engineer

Process Equipment Engineer

PVD Equipment Engineer

Staff Engineer – Devices

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>Perform preventive and corrective maintenance on sterile IV bag fillers, isolators, compounding equipment, sterilizers, component prep equipment, automated inspection machines, and secondary packaging systems.</li><li>Support equipment setup, calibration, and changeover in accordance with production schedules, maintenance plans, site SOPs, and cGMP requirements.</li><li>Assist in the installation, commissioning, and qualification of new sterile processing equipment, support equipment, and secondary packaging equipment.</li><li>Troubleshoot mechanical issues in real-time to minimize downtime while maintaining aseptic conditions and operator safety.</li><li>Ensure proper gowning, cleanliness, and contamination control practices when working in classified cleanroom environments.</li><li>Document all maintenance activities accurately in maintenance logs, work orders, and computerized maintenance management systems (CMMS).</li><li>Collaborate with Engineering, Manufacturing, and Quality to support equipment investigations, deviations, and continuous improvement initiatives.</li><li>Follow all safety procedures, including lockout/tagout, confined space, and PPE use; actively contribute to a culture of workplace safety and compliance.</li><li>Maintain spare parts inventory, tools, and maintenance supplies in an organized and audit-ready condition.</li><li>Participate in training and cross-functional activities to support plant startup and readiness for regulatory inspections.</li></ul> Requirements: <ul><li>High school diploma or technical certificate required, Associate’s degree in a mechanical or technical field preferred.</li><li>3+ years of experience as a mechanic or technician in a pharmaceutical, biotech, or sterile manufacturing environment.</li><li>Experience with isolator-based sterile filling equipment and cleanroom protocols is highly desirable.</li><li>Strong mechanical aptitude and experience with pumps, valves, conveyors, pneumatic systems, and packaging machinery.</li><li>Solid electrical and controls experience with automated systems, inspection machines, robotics, and camera systems highly preferred.</li><li>Working knowledge of cGMP, aseptic techniques, and safety regulations (OSHA, FDA, EU Annex 1).</li><li>Ability to read and interpret mechanical drawings, equipment manuals, and SOPs.</li><li>Familiarity with CMMS platforms and basic computer skills (e.g., Microsoft Office).</li><li>Self-motivated with strong attention to detail, problem-solving skills, and the ability to work independently or in a team.</li><li>Willingness to work flexible hours, including weekends or off-shifts during production or commissioning activities.</li></ul> Work Environment: <ul><li>Hands-on role in a cleanroom-based pharmaceutical manufacturing facility with strict safety and aseptic requirements.</li><li>Requires frequent gowning, standing, and work in confined or classified areas.</li><li>Fast-paced startup environment, requiring adaptability, initiative, and a collaborative mindset.</li><li>Occasional lifting of heavy tools or parts; use of ladders, lifts, and hand tools required.</li></ul>

Role Description: <ul><li>The Facility Engineer will play a critical role in the greenfield design, construction, startup, and long-term operation of a state-of-the-art sterile injectable IV bag manufacturing facility. This role will lead the implementation and management of all facility infrastructure systems, including cleanrooms, HVAC, utilities, building automation, environmental monitoring, chemistry and microbiology lab systems, and energy management, ensuring full compliance with cGMP standards and regulatory expectations for sterile manufacturing.</li><li>The Facility Engineer will collaborate with cross-functional teams during construction, commissioning, qualification, and beyond, ensuring the facility infrastructure reliably supports sterile production, patient safety, and long-term business goals.</li></ul> Responsibilities: <ul><li>Lead the design review, specification development, and technical oversight of facility infrastructure systems including cleanrooms, HVAC, compressed air, chilled water, WFI, clean steam, and other critical utilities.</li><li>Develop and maintain facility engineering standards, equipment specifications, and technical documentation aligned to regulatory requirements and aseptic processing standards.</li><li>Oversee construction, installation, commissioning, and qualification of facility utilities and infrastructure systems, ensuring timely, compliant project execution.</li><li>Collaborate with Validation, Quality, and Operations teams to ensure proper facility qualification (IQ/OQ/PQ) and environmental monitoring readiness.</li><li>Promote and ensure adherence to safety protocols and safe work practices.</li><li>Perform risk assessments for engineering and maintenance activities.</li><li>Establish and manage preventative maintenance programs, calibration schedules, and facilities management SOPs to ensure optimal equipment performance and facility reliability.</li><li>Provide technical expertise in troubleshooting facility system deviations, non-conformances, and CAPAs, ensuring timely resolution and sustained compliance.</li><li>Partner with EHS, Operations, and Quality to ensure all facility systems meet safety, regulatory, and operational expectations.</li><li>Manage relationships with external engineering firms, contractors, and utility service providers to ensure effective delivery of construction and facility services. 11.	Support energy management, sustainability initiatives, and continuous improvement efforts to optimize facility operating costs and resource utilization.</li><li>Ensure ongoing regulatory inspection readiness and serve as SME for facility systems during audits and inspections.</li></ul> Requirements: Qualifications/Experience: <ul><li>Bachelor’s degree in mechanical, Electrical, Industrial, or Facilities Engineering.</li><li>3+ years of relevant experience in pharmaceutical or sterile manufacturing facility engineering.</li><li>Strong technical knowledge of facility infrastructure systems including HVAC for aseptic manufacturing, cleanrooms, and critical utilities.</li><li>Direct experience with greenfield facility construction, commissioning, and qualification highly desirable.</li><li>Solid understanding of FDA cGMP regulations, USP standards, and applicable environmental, health, and safety requirements.</li></ul> Skills/Competencies: <ul><li>Expertise Experience in facility system design, commissioning, and lifecycle maintenance.</li><li>Strong project management and contractor/vendor coordination capabilities.</li><li>Excellent problem-solving and root cause analysis skills.</li><li>Strong understanding of aseptic manufacturing facility requirements and environmental controls.</li><li>Effective communication and cross-functional collaboration skills.</li><li>High attention to detail, safety, and compliance.</li><li>Ability to thrive in a dynamic greenfield/startup environment.</li></ul>

Role Description: <ul><li>The Process Equipment Engineer will be a key technical leader responsible for the design, specification, procurement, installation, qualification, and ongoing reliability of process equipment for a greenfield sterile injectable IV bag manufacturing facility.</li><li>This role will play a critical part in ensuring that all manufacturing equipment all sterile manufacturing equipment are compliant with cGMP requirements, supports aseptic processing standards, and are capable of delivering high-quality product performance from day one of commercial operations. </li><li>Equipment includes sterile isolators, compounding, automated inspection, and secondary packaging for the production of sterile IV bags.</li><li>Working cross-functionally during the startup phase, the incumbent will drive equipment readiness, validation support, and serve as a technical subject matter expert (SME) for process equipment throughout the facility lifecycle.</li></ul> Responsibilities: <ul><li>Lead the specification, selection, and procurement of sterile injectable manufacturing process equipment, including isolator filling lines, formulation vessels, mixing systems inspection equipment, secondary packaging equipment, and associated support systems.</li><li>Develop user requirement specifications (URS), functional specifications (FS), and detailed equipment design documentation in compliance with regulatory and operational standards.</li><li>Manage equipment vendors, design reviews, factory acceptance testing (FAT), site acceptance testing (SAT), and oversee equipment delivery, installation, and commissioning.</li><li>Promote and ensure adherence to safety protocols and safe work practices.</li><li>Perform risk assessments for engineering and maintenance activities.</li><li>Collaborate with Validation, Quality, and Operations teams to support equipment qualification (IQ/OQ/PQ) and ensure all systems meet regulatory expectations for sterile manufacturing.</li><li>Establish preventative maintenance programs, spare parts inventories, and equipment lifecycle management plans to ensure long-term equipment reliability and availability.</li><li>Provide technical expertise during troubleshooting, deviations, and investigations related to process equipment performance, ensuring rapid resolution of issues.</li><li>Partner with Manufacturing and Quality teams to optimize equipment performance, drive continuous improvement initiatives, and support ongoing process optimization.</li><li>Identify and implement process improvements to enhance operational safety, efficiency, and reliability.</li><li>Support development of SOPs, equipment manuals, and operator training programs to ensure safe and compliant operation of process equipment.</li><li>Ensure equipment designs fully comply with cGMP, FDA, OSHA, and all applicable regulatory and safety standards.</li><li>Contribute to capital project planning, budgeting, and project execution related to new equipment or facility expansions.</li><li>Ensure ongoing regulatory inspection readiness and serve as SME for process systems during audits and inspections.</li></ul> Requirements: <ul><li>Bachelor’s degree in mechanical engineering, Chemical Engineering, Industrial Engineering, or related field.</li><li>3+ years of experience in pharmaceutical process equipment engineering, with significant exposure to sterile injectable manufacturing strongly preferred.</li><li>Direct experience with design, procurement, and qualification of aseptic manufacturing equipment and cleanroom environments.</li><li>Solid understanding of cGMP regulations, FDA/EMA expectations, and engineering best practices for sterile operations.</li><li>Experience working in greenfield or major facility expansion projects highly desirable.</li></ul> Skills/Competencies: <ul><li>Strong technical knowledge of process equipment design, aseptic manufacturing, and utility systems.</li><li>Proven project management skills with ability to handle complex, cross-functional projects.</li><li>Excellent problem-solving abilities and root cause investigation experience.</li><li>Effective communication and vendor management skills.</li><li>Ability to work independently in a fast-paced, startup-like environment.</li><li>Strong teamwork, collaboration, and continuous improvement mindset.</li><li>High attention to detail with strong commitment to safety, compliance, and product quality.</li></ul>

Responsibilities: <ul><li>Perform equipment troubleshooting with systematic &amp; analytical mindset to minimize/eliminate downtime</li><li>Oversees decommissioning, movement, installation, upgrade, retrofit &amp; maintenance of manufacturing equipment</li><li>Monitors equipment uptime &amp; implement relevant improvement actions to improve equipment reliability &amp; solve chronic issues</li><li>Conduct training for line technicians to improve their technical competency and fan out critical knowledge relevant to achieve key departmental KPIs</li><li>Manage spare part cost &amp; availability</li><li>Collaborate with process engineers on yield related topics and implement relevant improvement/containment actions to prevent recurrence</li><li>Collaborate with external vendors on equipment troubleshooting, spare part availability/procurement &amp; equipment upgrade/retrofit</li><li>Participate or lead projects involving downtime reduction, cost saving, yield improvement or new material qualification.</li><li>Defines maintenance procedures &amp; upkeep documents related to the smooth running of manufacturing equipment</li><li>Coordinates equipment activities with inter and intra department personnel to ensure smooth execution</li></ul> Requirements: <ul><li>Bachelors degree in Computer Science, Electrical/Electronics Engineering, Engineering, or related field.</li><li>Hands on individual with experience in vacuum PVD equipments.&nbsp;</li><li>Dynamic team player who possesses good interpersonal skills</li><li>Strong passion &amp; drive to seek improvements to equipment &amp; process setup</li></ul>

Responsibilities: Design &amp; Development: <ul><li>Lead the design and development of drug combination products by understanding design space and managing critical design parameters.</li><li>Utilize SolidWorks and apply design for manufacturing (DFM) principles along with geometric dimensioning and tolerancing (GD&amp;T) to create sound engineering drawings.</li><li>Identify the best tools and approaches to effectively solve engineering problems.</li><li>Develop, optimize, and analyze designs using a combination of engineering principles, analytical methods, and experimental techniques.</li></ul> Technical Support &amp; Compliance: <ul><li>Support the evaluation and assessment of new technologies, intellectual property, products, and processes.</li><li>Provide support for existing products in terms of quality, manufacturing, and cost improvement.</li><li>Execute technical and cross-functional project work to ensure successful product development.</li><li>Develop and implement detailed test methods and write comprehensive technical reports based on design verification testing for design changes and product design activities.</li><li>Collaborate effectively with laboratory technicians and support staff.</li><li>Ensure compliance with quality policies, standard operating procedures, and regulatory requirements.</li></ul> Requirements: Regulatory &amp; Validation Expertise: <ul><li>Knowledge of Factory Acceptance Testing (FAT), Process Validation, and Installation Qualification/Operational Qualification/Performance Qualification (IQ/OQ/PQ).</li><li>Understanding of U.S. regulatory and quality requirements, including 21 CFR 820.3</li></ul> Experience: <ul><li>Minimum 8 years of engineering experience, with a preference for at least 5 years in product development.</li><li>Strong understanding of disciplined product development processes and quality requirements.</li><li>Experience in statistical tools, computer analysis, and engineering fundamentals for problem-solving.</li><li>Proficiency in SolidWorks is required.</li></ul> Skills &amp; Competencies: <ul><li>Strong interpersonal skills with the ability to collaborate effectively.</li><li>Excellent technical judgment and problem-solving abilities.</li><li>Demonstrated accountability for the successful completion of assigned tasks.</li></ul>

Skills

Industry

Location

Jobtitle

6 installation Jobs found

Field Service Engineer

Process Mechanic – Sterile Filling & Packaging

Facility Engineer

Process Equipment Engineer

PVD Equipment Engineer

Staff Engineer – Devices

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

EMPLOYER

TALENT

COMPANY

Contact Us

JOBS BY SKILLS

JOBS BY FUNCTION

JOBS BY INDUSTRY

JOBS BY LOCATIONS

MODEL JOBS

JOBS BY CITY

Skills

Industry

Location

Jobtitle

6 installation Jobs found

Field Service Engineer

Process Mechanic – Sterile Filling & Packaging

Facility Engineer

Process Equipment Engineer

PVD Equipment Engineer

Staff Engineer – Devices

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

EMPLOYER

TALENT

COMPANY

Contact Us

JOBS BY SKILLS

JOBS BY FUNCTION

JOBS BY INDUSTRY

JOBS BY LOCATIONS

MODEL JOBS

JOBS BY CITY

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