Quality Assurance Specialist/Engineer

Cybersecurity Generalist Senior Associate

Software Design Engineer

Regulatory Affairs Specialist (Pharma) - Singapore

Systems Design Engineer EVCC

Associate - Cyber Security Services

Vibration Specialist

Job Role: <ul><li>The Biomaterials Business Unit develops, produces and sells monomers and degradable polymers as raw materials for the medical and pharmaceutical industry.&nbsp;</li><li>Our products are used, among other things, in the production of medical devices and controlled release medicines.&nbsp;</li><li>The products are developed and produced to customer specifications in our factories in Gorinchem, The Netherlands and Tucker, GA, USA.&nbsp;</li><li>This requires very intensive contact with the customer. The application area and the specific market require a very high level of quality and service.</li><li>The Biomaterials Quality Assurance department ensures that raw materials, production process, packaging, storage, transport and service continuously meet and exceed these high standards.&nbsp;</li><li>This makes sure that our customers receive the consistent high quality product from our client that they have become accustomed to.</li></ul> Responsibilities: The Quality Engineer is responsible for ensuring procedures, systems and processes effectively meet the Quality and Regulatory requirements and Biomaterials business needs.&nbsp;The successful candidate will be a seasoned professional with experience in pharma, medical device or related FDA regulated industry.&nbsp;The individual should have a thorough working knowledge of ISO 9001; ICH Q7; CFR 210/211; CFR 820; ISO 13485 and other applicable regulations.&nbsp;As Quality Engineer you will be the quality lead in Strategic projects involving introduction of new production processes and/or introduction of new products. <ul><li>Support in maintaining and continuously improving the Quality Management System in compliance with GMP regulations and ISO requirements.</li><li>Provide compliance and quality guidance and training to the Operations, Research and Development and Quality Control departments.</li><li>Interact with internal stakeholders and internal/external customers to ensure Quality and Regulatory requirements for Strategic projects are identified and addressed as part of the project plan.</li><li>Drive the establishment of a proper quality control strategy for new processes and new products by applying quality risk management principles throughout the different phases of Strategic projects.</li><li>Coordinate Quality and Regulatory Affairs relating to Drug Master Files (DMF) and Device Master Files (MAF) ensuring filings meet requirements of Regulatory Agencies and business needs.&nbsp;</li><li>Support Commissioning, Qualification and Validation activities including associated documentation for new equipment.</li><li>Improve quality risk management procedures to ensure periodic review and performance reporting.</li><li>Maintain current knowledge of FDA, EMA and other international regulations, guidelines, and standards (such as ICH, USP, Ph. Eur.) applicable to industry. Monitor and identify developments to the legislations and translate these to the Biomaterials business.</li><li>Perform annual product reviews for commercial products.</li><li>Support the QA department with Audits, CAPA’s, Change Control, Deviations, Root-Cause Analysis, Non-Conformance and Complaint handling.</li></ul>&nbsp;Requirements: <ul><li>Bachelor’s or Masters degree in Chemistry, Engineering, Life Sciences or other relevant area.</li><li>Minimum 2 years of experience as a Quality Engineer in pharmaceutical, medical device or other related industries.</li><li>Experience in maintaining Regulatory filings current and responding to requests from Regulatory Authorities.</li><li>Experience with Commissioning, Qualification and Validation activities for new production equipment.</li><li>Experience in applying Quality Risk Management principles and tools (ICH Q9, HACCP, FMEA, HAZOP, etc.).</li><li>Working knowledge of ISO 9001, ICH Q7, FDA CFR 210/211, CFR 820, ISO 13485 and other applicable regulations.</li><li>Strong written and verbal communication skills, in English and preferably in Dutch.</li><li>Some exposure to customer audits and/or regulatory agency inspections (e.g. FDA, notified bodies, etc.).</li><li>Proven ability to work cross-functionally to achieve business outcomes.</li><li>Attention to detail, commitment to quality, accuracy, efficiency, and consistency.</li><li>Ability to travel occasionally as determined by business requirements.</li></ul>

Responsibilities : <ul><li>Design Cybersecurity framework based on business objectives and strategic imperatives of the client organisation including goals, vision, mission, and operational plans</li><li>Devise a cybersecurity strategy encompassing enterprise security architecture, design, and program transformation</li><li>Design and operate governance and security processes at system, network and application levels</li><li>Maintain continuous communication with key stakeholders in support of the security strategy, and plan and solicit feedbacks, to uplift the programs and capabilities</li><li>Be abreast of best practices, vendor capabilities, and frameworks, to sustain a best-in-class and highly innovative security program</li><li>Monitor processes and drive improvements in efficiency and quality of security program</li><li>Assist in development of workflows for transitioning strategic plans into implementation plans and operational readiness</li><li>Facilitate strategic planning initiatives, documentation, technical roadmaps and security tool rationalisation</li><li>Define security policy and standards framework definition</li><li>Assist in designing the security organisation structure</li><li>Develop security policies, procedures, standards based on the security strategy and roadmap</li><li>Review of cybersecurity policies and processes to identify gaps in design of control based on comprehensive assessment framework</li><li>Conduct security process implementation reviews to assess security effectiveness and reporting</li><li>Conduct Current State Assessment of cybersecurity practices against the defined controls and provide recommendations for to-be state</li><li>Define risk management techniques around threats and vulnerabilities identified</li><li>Conduct Risk Assessment and Threat Assessment based on best practices to realise the cybersecurity strategy</li><li>Run Cyber Security Diagnostic Assessments and develop programs for cybersecurity skill development and enhancement</li><li>Design cybersecurity awareness and stakeholder sensitisation program including materials, posters, newsletters, training workshops, etc.</li><li>Provide certification advisory across Information Security Management System (ISMS), Privacy Management System (PMS), Business Continuity Management Systems (BCMS), PCI DSS etc.</li><li>Implement security controls for realisation of the certification requirements and provide technology roadmap based on the security strategy</li></ul> Requirement : <ul><li>Bachelor’s degree in Computer Science, Information Systems, Information Technology, Engineering, or equivalent education</li><li>Minimum 2 - 4 years of relevant experience</li><li>Essential Skills: Professional certifications – relevant cybersecurity certification, CISSP/CISA/CISM/ISO 27001 Lead Auditor, ISO 27001 Lead Implementer, ISO 22301 Lead Implementer, ISO 29001 Privacy</li><li>Knowledge of PCI, NIST and other security standards</li><li>Strong interpersonal skills and customer service skills</li><li>Deliver in highly collaborative and impactful manner</li><li>Proficient in development of high-quality professional presentation for business</li><li>Passionate about analysing evolving security challenges, and developing innovative security solutions working with internal customers</li><li>Coordinate between business stakeholders and technical teams</li><li>Strong oral and written skills involving both business and technical sides</li></ul>

Role Description: <ul><li>We are seeking an experienced Software Design Engineer to join the HVOR OST Product development group.</li><li>You are someone with demonstrated success and industry experience as Software Design Engineer with Architecture, Design &amp; Development of Embedded/Control Systems.</li><li>The Software Design Engineer will be responsible for the architecture, design, development, testing, and deployment of system software to implement various internal software packages relating directly to electronics &amp; electrical engineering requirements.</li><li>He/She will be responsible to take ownership of product solution and lead the team technically.</li></ul> Responsibilities: <ul><li>Should participate in customer requirement understanding and capture requirements in detail.</li><li>Responsible for Architecture, Design &amp; Implementation of new product development.</li><li>Review design and implementation.</li><li>Leads the development of software to control external hardware for automated test equipment and other applicable development.</li><li>Design the solution approach and come out with optimized effort estimates.</li><li>Lead the team technically and provide technical guidance to team.</li><li>Guide and Mentor Team and provide direction to team for implementation and solving issues.</li><li>Should take ownership of deliverables and drive independently.</li><li>Involve resolving product related issues.</li><li>Contribute towards excellence in a high collaborative, team-oriented environment.</li><li>Work closely with Project Manager and other team members.</li><li>Prepares software release documentation and supports the release to manufacturing of the product software.</li><li>Takes ownership of design &amp; deployment challenges brought forward during pre-production and full production stages of project.</li><li>Ensures the software source code and documentation is properly archived.</li><li>Redesigns existing software in an effort to reduce complexity, improve performance, or to enhance capabilities of products as assigned.</li><li>Makes recommendations regarding new product or feature opportunities using new or existing software design techniques.</li><li>Creation and maintenance of software specifications from systems specification documents.</li><li>Communication and collaboration with global team members for development.</li></ul> Requirements: <ul><li>10+ years of hard-core experience with Embedded/Control Systems.</li><li>4+ years of experience with Architecture and Design of Embedded/Control Systems.</li><li>Experience to guide and mentor team technically.</li><li>Must be a team player able to work in a fast-paced environment with demonstrated ability to handle multiple competing tasks and demands.</li><li>Needs to have good experience with serial communications: CAN (J1939, UDS, CAN Open), LIN, and SPI.</li><li>Embedded Firmware Development experience with micro-controllers and peripherals in C or C++. Knowledge of compilers/assemblers and linkers (8/16 or 32 bit).</li><li>Experience in diagnostic-based software test tool maintenance (C# - parameter programmer, data collection, validation).</li><li>Functional Safety process experience: IEC-61508, ISO-25119, and/or ISO-26262 is a major plus.</li><li>Experience on using version control system like Git.</li><li>Experience working with Systems Engineers is a major plus.</li><li>Strong communication skills; oral, written and presentation.</li><li>Strong organization, planning and time management skills to achieve results on time.</li><li>Strong personal and professional ethical values and integrity.</li><li>Holds self-accountable to achieving goals and standards.</li><li>Proficient in Microsoft Office programs (Outlook, Word, PowerPoint, and Excel).</li><li>Strong interpersonal &amp; collaboration skills to work effectively with all levels of the organization including suppliers and/or external customers.</li><li>Strong Analytical skills and Problem-Solving capabilities.</li></ul> Qualifications <ul><li>Bachelor or Master degree in Electronics/Electronics &amp; Communications/Instrument &amp; Control/Embedded Systems or equivalent required.</li></ul>

Responsibilities: <ul><li>Negotiate with local authorities on behalf of company objective. Act as the key person to communicate and negotiate with local regulatory authorities.</li><li>Coordinate efforts associated with the preparation of regulatory documents or submissions.</li><li>Prepare and submit all the required product registration documents and other relevant license application.</li><li>Notify and update Health science Authority (HSA) and/or local country product registration of any change of particulars / documents related to product registration.</li><li>Manage adverse event and field safety corrective action reporting to HSA and/or local country product registration within the stipulated timeline.</li><li>Ensure changes to the approved products are timely submitted to HSA and/or local country product registration as required.</li><li>Maintain product registration record and product registration database to ensure proper documentation and record filing.</li><li>Maintain QMS (e.g. Good Distribution Practice for Medical Devices, GDPMDS) and implement any changes required including training and communications with affected parties.</li><li>Responsible for all quality control duties such as establishment, verification and implementation of all quality control procedures in respect of quality system to comply with all statutory GMP &amp; ISO standards.</li><li>Handle product complain, reporting adverse events and recall to the local regulatory authorities as required.</li><li>Create training materials and train employees to improve regulatory skills in local office or region and at our manufacturers, where applicable.</li><li>Support in both internal /external QMS audit.</li></ul>&nbsp;Requirements: <ul><li>Degree in Pharmacy with a valid Singapore pharmacist licence</li><li>At least with 2 years working experience in Regulatory Affairs in Pharmaceutical, Experience in Pharmaceutical, Nutrition and Medical Device will be an advantage.</li><li>Good written and verbal communication skills</li></ul>

Responsibilities: <ul><li>Provides technical leadership within a cross functional team&nbsp;</li><li>Working closely with customer technical and project personnel</li><li>Handles both external and internal stakeholder requirements for new products / features / technology developments</li><li>Identifies, analyzes, and resolves system design weaknesses</li><li>Develops system specifications and formalized representations of solutions (for example, flow charts, models) to develop systems that meet customer needs</li><li>Systems Architecture development with roadmaps to increase feature sets, reduce cost, pursue integration opportunities, and increase quality</li><li>Leads internal sub system design teams to refine implementation of products / features / technologies &amp; specifications to ensure they meet stakeholder’s needs</li></ul> Requirements:&nbsp; Experience / Qualifications <ul><li>A university degree required (i.e., Bachelor’s degree) with 6 years to 10 years work experience.</li><li>Must be a team player able to work in a fast-paced environment with demonstrated ability to handle multiple competing tasks and demands</li><li>Strong communication skills; oral, written and presentation</li><li>Strong organization, planning and time management skills to achieve results</li><li>Strong personal and professional ethical values and integrity</li><li>Holds self-accountable to achieving goals and standards&nbsp;</li><li>Proficient in Microsoft Office programs (Outlook, Word, PowerPoint, and Excel)</li><li>Strong interpersonal &amp; collaboration skills to work effectively with all levels of the organization including suppliers and/or external customers</li></ul> Essential <ul><li>Knowledge of Enterprise Architecture or other UML tools</li><li>Knowledge of Agile/Scrum methodology</li><li>Proven ability to work collaboratively in a cross-functional team and deliver results&nbsp;</li><li>Experience developing products/systems compliant to ASPICE</li><li>Experience using Atlassian JIRA</li><li>Functional/Nonfunctional requirement analysis, perform tradeoff analysis, Architect, design and develop efficient, Scalable, and portable SWC that can be deployed across customer programs.</li><li>Definition and architecture of full Software stack for Control units like Electric Vehicle Charging Controller (EVCC). Specification of SW architectural and functional requirements for Control units like EVCC. Ensure optimal usage of functional/nonfunctional architectural requirements like RAM, ROM, CPU load, I/O ports, hardware function deployment for multicore platform, network bandwidth etc.</li><li>Excellent understanding of development processes, like Agile or v-model, skilled in the use of source control tools such as SubVersion/GIT and be familiar with the full product development lifecycle.</li><li>Understanding and experience of the software development toolchain: Requirements capture tools, bug/issue tracking tools, IDEs, software analysis and testing tools, documentation tools, compilers, and debuggers</li><li>Proven ability to work collaboratively in a cross-functional team and deliver results</li><li>Knowledge of Requirements Management tools</li><li>Revision control (Configuration management)</li><li>Requirement’s decomposition planning and reporting (KPI generation)</li><li>Test plan development</li><li>Test execution planning</li><li>Working knowledge of IS0 26262, ISO 25119, ISO 13849, IEC 61508</li></ul> Lead creation of: <ul><li>Detailed discipline specific design description</li><li>Mechanical/Electrical and hardware/software interface specifications</li><li>8D reports</li><li>Timing Plans</li><li>Other documents, as needed</li><li>Actively pursue cost saving ideas</li><li>Documents innovative solutions and proposes patent applications</li><li>Work assignments primarily involve intermediate through advanced level work, moving toward complete technical competency and mastery of the field</li><li>Performs other duties as necessary in support of business objectives. Ensures that facilities are in full compliance with all safety regulations</li><li>Complies with the requirements of Quality Management System (QOS)</li></ul>

Responsibilities: <ul><li>As an Associate – Cyber Security Services you will provide 24x7 technical support for issues that involve our Cloud Managed Services customers cloud services. You will operate under pressure to isolate problems which are directly affecting our customer systems.</li><li>Using your experience, technical knowledge and company provided Knowledge Base Articles you will identify a customer’s needs and resolve Incidents or Service Requests. If an escalation is needed when troubleshooting, you have the support of your tier 2 peers.</li><li>You will be working in a fast-paced environment supporting our customers around the world. You will need to keep your skills up-to-date and relevant for the cloud technologies which we offers services for.</li><li>You will monitor the remote monitoring and management system alerts and notifications, and respond accordingly through service tickets. Your excellent written language skills will be used to communicate with customers through email and the IT Service Management tool.</li><li>Your excellent spoken language skills will be used for communication with customers as required; keeping them informed of incident progress, notifying them of updates for Service Requests.</li><li>The team which you work in provides support services focused on security technologies across Workplace, Data Center and other cross functional line of services. As a member of this team you will have the opportunity to develop your deep technical knowledge or broaden your skills across the different Practice areas.</li><li>Perform health checks on security solution regularly and help detect</li><li>incidents before there is any impact</li><li>Monitor and measure system resources, and if needed, resolve Issues related to</li><li>security incidents related to emails, changes and problem tickets;</li><li>Provide inputs to technical documents based on repeat incidents and help assist</li><li>SMEs during problem resolution;</li><li>Provide inputs to technical documents based on repeat incidents and help assist</li><li>SMEs during problem resolution</li><li>Troubleshoot security related service issues as they occur and follow up with after action reviews;</li><li>Follow Incident, Request, Problem, Change and Access Management processes</li></ul> Requirements: <ul><li>Minimum 3+ years of experience working in a Security Operation Centre</li><li>Have a good understanding and awareness of 2 or more of the following:</li><li>Proof Point ,FireEye ,Trend Micro Deep Security, Trend Micro ApexOneDigital Guardian, Qualys Guard / Metasploit / Nessus Tenable, Microsoft M365,McAfee CASB, Cisco Meraki, Splunk Enterprise and Security, Okta, CyberArk</li><li>Have a good understanding of ticket management and service requests</li><li>Have a good understanding of Security Operations and Service Delivery</li><li>Exposure to ISO 27001, PCI related certification and compliance practices</li><li>Awareness and expertise of using at least 1 Enterprise Ticketing system</li><li>ITIL processes in supporting Security Solutions and Service Delivery</li><li>Engineering Degree in Computer Science or Technical Degree with certifications in Information Technology or Information Security</li><li>Good command in English, other foreign languages are a plus;</li><li>Good cross-cultural communication skills;</li><li>Ability to interact with various teams and customer;</li><li>Be a Team Player and Fast Learner;</li><li>Share best practices and proactively suggest continuous improvement;</li><li>Escalate operational issues to management when needed;</li><li>Willing to work in 24x7 shifts</li><li>Cisco certifications such as CCNA</li><li>Microsoft certifications such as MCSA, MS-100, MS-101 and MS-500</li></ul>

<h2>About our partner:</h2>Our Partner occupies a unique position in the global energy industry. They are the worlds largest producer of hydrocarbons (oil and gas), with the lowest upstream carbon intensity of any major producer. With their significant investment in technology and infrastructure, they strive to maximize the value of the energy they produce for the world along with a commitment to enhance our partners value to society.Headquartered in the Kingdom of Saudi Arabia, and with offices around the world, they combine market discipline with a generations’ spanning view of the future, born of their nine decades experience as responsible stewards of the Kingdom’s vast hydrocarbon resources. This responsibility has driven our partner to deliver significant societal and economic benefits to not just the Kingdom, but also to a vast number of communities, economies, and countries that rely on the vital and reliable energy that they supply. <h1>The Role</h1>Our Partner is seeking a Vibration Specialist&nbsp;to join the Rotating Equipment Division of Consulting Services Department. The Rotating Equipment Division is responsible for providing effective specialized engineering consultation, introducing viable technologies and maintaining quality standards. The Vibration Specialist&nbsp;primary role is to provide technical support on issues related to rotating and static equipment vibration for the support of projects and operation activities. <h2>Key Responsibilities:</h2><ul><li>Perform vibration measurement.</li><li>Perform complex vibration analysis.</li><li>Review rotor dynamics designs of new machines.</li><li>Perform model analysis of parts and systems.</li><li>Design detailed vibration tests for rotating equipment, piping and structure systems</li><li>Perform simulations for rotating equipment and their system.</li><li>Perform modal analysis on machines, piping and structural. </li><li>Witness Factory Acceptance Tests &amp; review tests’ results</li><li>Deliver in-house Vibration training.</li><li>Mentoring/transferring experience/knowledge to young engineers.</li></ul> <h2>Minimum Requirements:</h2><ul><li>Bachelor of Science in Mechanical Engineering. Advanced degree is highly preferred, but not required.</li><li>Over 9 years of experience preferably in the oil industry or similar process industry.</li><li>Have experience with maintenance programs and setting vibration monitoring programs for operating facilities.</li><li>Have an in-depth knowledge of Mechanical Engineering principles and the ability to reflect them in engineering projects from conceptual to detailed engineering stages.</li><li>Have extensive experience in the measurement and analysis of vibration and configuration of online monitoring systems.</li><li>Fully familiar with international codes that are related to vibration of rotating equipment, instrumentation, protection system and condition monitoring systems.</li><li>Have experience in machines’ rotor dynamics design.</li><li>Have experience in machines’ high vibration troubleshooting and solutions. </li><li>Have machinery knowledge (Compressors, Steam Turbines, Gear units, Pumps, Gas Turbine and motors) </li><li>Fully aware and up to date with related vibration international standards such as API and ISO.</li><li>Have Fundamentals of Engineering, Professional Engineering, Chartered Engineer, Vibration Analyst CAT-III or IV certification or equivalent is highly desirable.</li></ul> <h2>Working environment</h2>Our high-performing employees are drawn by the challenging and rewarding professional, technical and industrial opportunities we offer, and are remunerated accordingly.Our people work on truly world-scale projects, supported by investment in capital and technology that is second to none. And because, as a global energy company, we are faced with addressing some of the world’s biggest technical, logistical and environmental challenges, we invest heavily in talent development.We have a proud history of educating and training our workforce over many decades. Employees at all levels are encouraged to improve their sector-specific knowledge and competencies through our workforce development programs – one of the largest in the world.

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7 iso Jobs found

Quality Assurance Specialist/Engineer

Cybersecurity Generalist Senior Associate

Software Design Engineer

Regulatory Affairs Specialist (Pharma) - Singapore

Systems Design Engineer EVCC

Associate - Cyber Security Services

Vibration Specialist

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7 iso Jobs found

Quality Assurance Specialist/Engineer

Cybersecurity Generalist Senior Associate

Software Design Engineer

Regulatory Affairs Specialist (Pharma) - Singapore

Systems Design Engineer EVCC

Associate - Cyber Security Services

Vibration Specialist

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

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