Validation Engineer

Design Quality

R&D Specialist

Product Owner - Product Lifecycle Management (PLM)

Senior Specialist - LIMS Administration

Costing

Quality Assurance Specialist/Engineer

Sr. Manager / DGM-Costing & MIS

FPGA Engineer

Downstream Pricing Data Analytics

Responsibilities: <ul><li>The Validation Engineer works alone and as part of the Engineering Department to author and execute IQ/OQ/PQ protocols, engineering studies, facility qualifications and other documents related to production and business systems.</li><li>They will also be responsible for engineering and maintenance projects, such as repairs, upgrades or replacements as the need arises.</li><li>They will work with quality, technical operations and production to identify and resolve issues.&nbsp;</li><li>Adhere to all company and cGMP procedures as well as applicable safety regulations.</li><li>Author change controls, SOPs and protocols.</li><li>Protocols o Generates and executes validation protocols, and summarizes studies to ensure compliance with manufacturer and SPI specifications, with current Good Manufacturing Practices, and national standards.</li><li>Responsible for confirming all communicated validation plans to applicable management.</li><li>Provides technical assistance in the form of rationales or validation studies.</li><li>Responsible for effectively adopting modern validation techniques, current industry practices, risk management principles, science-based approaches and a strong understanding of processes and equipment.</li><li>Troubleshoots and resolves issues as needed.</li><li>Manage multiple projects with competing deadlines.</li><li>Manage external resources to complete tasks outside SPI’s capabilities.&nbsp;</li><li>Manage approvers of documents and procedures and ensure timely closure of tasks.</li><li>Manage project-related Change Requests form initiation through closure, including presentation to Change Control Committee.</li><li>Assist with deviation investigation and identify areas for CAPAs as needed based on root causes.</li><li>Source and procure equipment, supplies and other materials as needed.</li><li>Develop and maintain cross-functional relationships.&nbsp;</li></ul> Requirements: <ul><li>Bachelor of Science in Engineering or Science discipline preferred.</li><li>Experience in pharmaceutical (i.e. Validation/QA or R&amp;D), medical device, biotechnology industries.</li><li>In-depth knowledge of the pharmaceutical plant operations is an asset.</li><li>Proficient in Microsoft Word, Excel, Power Point, Project, AutoCAD and other software relevant to the performance of the Job</li><li>Experience authoring change controls in Trackwise or other management system.</li><li>Experience authoring SOPs in MasterControl or other management system.</li><li>Integrity – Works with integrity and ethically; Demonstrates accuracy and thoroughness; Looks for ways to improve and promote quality; Applies feedback to improve performance; Monitors own work to ensure quality.</li><li>Collaboration – Works well in group problem solving situations; Speaks clearly and persuasively in positive or negative situations; listens and gets clarification; Responds well to questions.&nbsp;</li><li>People – Treats people with respect; Keeps commitments; inspires the trust of others; Demonstrates knowledge of EEO policy; Shows respect and sensitivity for cultural differences; promotes a harassment-free environment.</li><li>Responsive – Identifies and adapts to priority issues as they arise; Communicates with management and team members effectively; Works quickly and efficiently.</li><li>Proactive – Identifies and resolves problems in a timely manner; Gathers and analyzes information skillfully; Develops alternative solutions.</li><li>Organized – Tracks deadlines and adheres to schedules; Writes clearly and informatively; Presents numerical data effectively.</li><li>Learning Mindset – Adapts to unfamiliar situations as needed; Open to new ideas and methods; Readily familiarizes self with new equipment and processes.</li><li>Regularly lift and /or move up to 10 pounds and occasionally lift and/or move up to 50 pounds.</li><li>Climb ladders and work in high, precarious places up to elevations of 75 feet.</li><li>Regularly exposed to work near moving mechanical parts.</li><li>Exposed to wet or humid conditions.</li><li>Exposed to outdoor weather conditions.</li><li>Regularly exposed to high noise environments.</li><li>Exposed to extremely dusty environments.</li><li>Exposed to chemicals used in the manufacturing process.</li></ul>

Responsibilities: <ul><li>To validate the form, shape and highlights.</li><li>Freeze gap and flush values.</li><li>Part by part Creation on EAAR.</li><li>Converge design to engineering.</li><li>Bench mark study &amp; proposals.</li><li>Finalise color, grain and texture with C&amp;M designer.&nbsp;</li><li>Draft angle analysis to achieve good aspect.</li><li>Discussion &amp; Negotiation with supplier, CDMM &amp; grainer for Digital grain mapping sign off.</li><li>Monitor &amp; delivery of project delivarables.</li><li>To validate shape / Volume / highlights on all class A physical parts based on Class A release.</li><li>Shape &amp; cavity validation (Plastic &amp; Metal).</li><li>Discuss with grainer for better texture reachability and aspect.</li><li>To validate physical grain mapping, Cavity validaiton &amp; provide Graining go ahead.</li><li>To validate Grain, Color, gloss &amp; aspect.</li><li>Seats validation</li><li>Vehicle Pre harmony &amp; harmony validation</li><li>Maintenance &amp; Calibration of masters</li><li>Calibration of Equipments</li><li>Bench mark study &amp; proposals.</li><li>Support for color homologation.</li></ul> Requirements: <ul><li>Good Eye vision and good knowledge of design execution.</li><li>Excellent skill on Catia, TC, Alias basic</li><li>Good Stamping, Tooling, Injection, painting &amp; Assy process knowledge.</li><li>Basic skill on A2mac, Benchmark software.</li><li>MS Office with Exctl. presentation skill</li><li>Exctl. communication skill with team and suppliers.</li><li>Good planning and organising skill.&nbsp;</li><li>Good problem solving skill.</li><li>Good Team work skill.</li><li>10+ Years relevant design background in automotive field.</li></ul>

Responsibilities: <ul><li>Identify the needs and gaps in the product portfolio along with the category managers (marketing)</li><li>Build the product portfolio to bridge the gaps and aligned to the portfolio planning.</li><li>Scout for advanced technologies and build technology partnerships (develop, acquire, partner) to build a rich IP portfolio for these category</li><li>Technology partner management</li><li>Compliance (products &amp; components) to relevant test protocols, safety standards and regulatory requirements</li><li>Identify/ Build the pool of suppliers of high quality products and critical components</li><li>Project Management activities</li></ul> Requirements: <ul><li>Working experience in water product category with exposure to Water purifiers and water filtration mechanisms</li><li>Understanding of the core concepts of water flow dynamics, water management, filtration systems and filter media&nbsp;</li><li>Fully conversant with emerging sub and the futuristic trends in domestic water segment.</li><li>Exposure to Smart &amp; connected products, Sensors, display to build products with self-diagnostic capabilities and data generation</li><li>Knowledge of regulatory &amp; safety requirements and test protocols as per Indian &amp; global standards</li><li>Creativity and analytical skills</li><li>Engineering graduate in Mechanical</li><li>Should have Good written/ oral communication skills, inter-personnel skills and Self-motivation.</li><li>A good team player, capable of handling and motivating a team for successful project delivery</li></ul>

Role Description: <ul><li>Understand business needs to validate, plan and develop PLM initiatives to streamline and improve the processes needed to develop our products.</li><li>You will own the digital and analytics roadmap for the function, developing the digital strategy alongside multi-functional colleagues, while taking an active role in the evaluation, approval and implementation process of new tools and applications.&nbsp;</li></ul> Responsibilities: <ul><li>Develop the emerging agenda for the department by creating and assessing business case value and impact potential, scoping out use case and implementation plans.</li><li>Own Product &amp; Lifecycle Management and support prototype development and implementation with Digital Strategy and IT teams.</li><li>Lead the deployment of PLM solutions by contributing expert product release experience, through pilot phases through to launch.</li><li>Take a lead role in change management and driving adoption of tools and processes, ensuring appropriate governance and performance metrics are in place to realise business value</li><li>Support the integration of related departments and external partners by utilising communication platforms and outstanding programs for key collaborators</li><li>Support validation of existing processes or feasibility of process adaptations by: ensuring that agreed targets are met with tangible or intangible benefit; providing meaningful recommendations on processes changes; Ensure awareness and alignment of the team to our clients Standards, Principles and Practices (CSV)</li></ul> Requirements: <ul><li>University degree (BSc, MSc) in Engineering, Computer Science, Mathematics, Automation, or related fields.</li><li>IT Service Management, ITIL certification is a plus.</li><li>At least 3 years’ proven experience in the domain or with use cases of Digital Systems, Data Science, Manufacturing Engineering, Robotic Process Automation or Industrial IoT solutions, preferably as a Product Owner role.</li><li>Knowledge of Computer System Validation (CSV) environment.</li><li>Demonstrable expertise in project management (Agile and/or Waterfall) additional certification is beneficial.</li><li>Solution &amp; data driven mindset, able to think critically while dealing with ambiguity and fast paced projects.</li><li>Proficiency in English both oral and written.</li></ul>

Responsibilities: <ul><li>Prepares crystal reports.</li><li>Creates or approves static data entries.</li><li>Adds/modifies calculations, workflows, and schemas as necessary.</li><li>Codes LIMS system to customize software platform.</li><li>Integrates and customizes software with laboratory instrumentation</li><li>Responsible for instrument integration.</li><li>Builds Crystal Reports.</li><li>Builds/Configure Electronic Laboratory Notebooks.</li><li>Participate in cross-site implementation of new LIMS features and enhancements</li><li>Coordinates roll-out of additional LIMS phases..</li><li>Assists in Project Planning and Budget Spending.</li><li>Performs periodic audits on the system, collates and presents the results of the audit to senior management.</li><li>Develop training modules and provide user training as necessary.</li><li>Interact with laboratory personnel to ensure necessary developments are present and functioning, as necessary.</li><li>Interface with IT department on global LIMS issues.</li><li>Follows EH&amp;S procedures to ensure a safe work environment.</li><li>Performs other LIMS-related responsibilities as required by management.</li></ul> Requirements: <ul><li>Bachelor’s degree in life science, physical science, or technology field with 5+ years’ laboratory experience performing development functions for a GMP laboratory</li><li>3+ years’ experience within software development</li><li>Worked within a regulated environment (Pharmaceuticals, Medical Devices, Biotech or other regulated field)</li></ul> Knowledge: <ul><li>Knowledge of 21 CFR Part 11</li><li>Strong knowledge of Computer System Validation techniques and practices</li><li>Company SOPs applicable to job</li><li>Thorough knowledge of general routine laboratory operations and workflow, with the ability to integrate those processes into an electronic workflow</li><li>Strong understanding of Company SOPs applicable to job</li><li>GMP Knowledge of FDA regulations, primarily GMP regulations</li><li>Thorough knowledge of general routine laboratory operations and workflow, with the ability to integrate those processes into an electronic workflow</li><li>In-depth knowledge of Crystal Reports, SQL programming, and SSL scripts or other varying scripting languages such as JavaScript, SQL, Java</li></ul> Skills &amp; Abilities: <ul><li>Advanced computer skills</li><li>Strong attention to detail. Highly productive, able to manage time and prioritize tasks to meet timelines</li><li>Strong interpersonal and communication skills; confident presenter, clear, concise technical writer.&nbsp;Able to interact with various departments and levels</li><li>Customer focused</li><li>Troubleshooting and critical thinking skills. Able to define problems, collect data, establish facts and draw conclusions</li></ul>

* Proven work experience as a Cost Accountant, Cost Analyst or similar role, should have worked &#10;independently in all aspect of Costing Department and to work with close co-ordination with CFO on all &#10;costing related work.&#10;* Preparation / monitoring the precosting (New Enquiry / Updating / Target/Costing for new product Development&#10;* Preparation &amp; analysis of post costing of all products with detailed observation and recommendation to management&#10;* Should have worked on Cost Improvement Project validation with proper inputs&#10;* Cost Audit Report&#10;* Budgetary activities of the company., Product costing, Pricing etc.&#10;* MIS Reporting &amp; Trend Analysis,&#10;* Work closely with Technology partner on Various report development which help timely decision making by Top Management&#10;* Excellent analytical skills with an attention to detail&#10;* Identify and recommend cost-effective solutions.

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: <ul><li>The Quality Engineer is responsible for ensuring procedures, systems and processes effectively meet the Quality and Regulatory requirements and Biomaterials business needs.&nbsp;</li><li>The successful candidate will be a seasoned professional with experience in pharma, medical device or related FDA regulated industry.&nbsp;</li><li>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;</li><li>As Quality Engineer you will be the quality lead in Strategic projects involving introduction of new production processes and/or introduction of new products.</li><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>Proven work experience as a Cost Accountant, Cost Analyst or similar role, should have worked independently in all aspect of Costing Department and to work with close co-ordination with CFO on all costing related work.</li><li>Preparation / monitoring the precoating (New Enquiry / Updating / Target/Costing for new product Development</li><li>Preparation &amp; analysis of post costing of all products with detailed observation and recommendation to management</li><li>Should have worked on Cost Improvement Project validation with proper inputs</li><li>Cost Audit Report</li><li>Budgetary activities of the company., Product costing, Pricing etc.</li><li>MIS Reporting &amp; Trend Analysis,</li><li>Work closely with Technology partner on Various report development which help timely decision making by Top Management</li><li>Excellent analytical skills with an attention to detail</li><li>Identify and recommend cost-effective solutions.</li></ul> Requirements: <ul><li>CMA</li><li>10-12 years of relevant experience in Manufacturing Industry &amp; relevant profile</li></ul>

Responsibilities:&nbsp; <ul><li>Work with software and design teams to understand the functional and performance goals of MCU design.</li><li>Follow the FPGA/Emulation process flow and platforms across multiple pre-silicon design projects while working with Emulation team members across multiple geographies.</li><li>Implement and debug FPGA design primarily on Stratix-10 development board using Quartus.</li><li>Assist software and validation teams in reproduction, triage, and debug of issues.</li><li>Support a regression test suite consisting of system-level test cases to validate updated FPGA builds.&nbsp;&nbsp;</li></ul> Requirements: <ul><li>BSEE or BSCE with 5+ years of SoC design, verification, or related work experience and 2+ years of experience of FPGA design, bring-up, debugging, and verification;&nbsp;&nbsp;</li><li>In-depth knowledge of top-down FPGA development process with recent experience with FPGA-based prototyping on a platform comprising one FPGA;</li><li>Expertise in Intel Quartus Prime Pro or Xilinx Vivado suites with emphasis on Quartus Prime Pro 19.x and later;&nbsp;&nbsp;</li><li>Solid understanding of the tool flow from RTL to bitstream;</li><li>In-depth experience writing Verilog code and FPGA timing analysis;</li><li>Familiarity with source code control systems (git) required;</li><li>Familiarity with languages such as C/C++, Make, TCL, Python script is a plus;&nbsp;</li><li>Familiarity with embedded systems and interfaces such as I2C, SPI, MSPI, UART, USB, SDIO, MIPI is a plus.</li></ul>

Responsibilities: <ul><li>Develop, maintain and continuously improve fit-for–purpose price forecast visualization tools.</li><li>Consult with Pricing Insights and Market Analysis team and AEs to gather information on global events affecting energy/ oil &amp; gas market and market trends.</li><li>Gather data from forward curves of all crude and products, market premium or discount values, costs of freight and other elements of Transfer Prices.</li><li>Compute transfer prices daily for M till M+3, according to the planning cycle.</li><li>Coordinate with AEs &amp; market insights for review and validation of prices to be issued</li><li>Issue price forecast weekly to the AEs to ensure timely identification of opportunities, estimate uplift margins and serve as a basis for negotiations among stakeholders.</li><li>Issue actual transfer prices on the last day of M-1 for M, to allow for timely review.</li><li>Perform periodic lookback of TP forecasting quality and identify trends.</li><li>Perform random checks and assist OAD to QA implemented prices on Standard and Non-Standard Cargoes.</li></ul> Requirements: <ul><li>Bachelor Degree in Statistics, Commerce, Marketing, Engineering, Business Administration or closely related specialty.</li><li>Post-graduate education or equivalent experience in MBA/ Statistics/Economics is desirable.</li><li>Deep knowledge of model development and utilization of excel functions.</li><li>Decent understanding of downstream business and supply chain.</li><li>5 to 10 years relevant professional experience (preferable in oil &amp; gas downstream business), including several years in field as data analytics including market research, corporate planning, business development).</li><li>Must have excellent communication and interpersonal skills and work effectively in cross functional teams.</li></ul>

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47 validation Jobs found

Validation Engineer

Design Quality

R&D Specialist

Product Owner - Product Lifecycle Management (PLM)

Senior Specialist - LIMS Administration

Costing

Quality Assurance Specialist/Engineer

Sr. Manager / DGM-Costing & MIS

FPGA Engineer

Downstream Pricing Data Analytics

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Skills

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47 validation Jobs found

Validation Engineer

Design Quality

R&D Specialist

Product Owner - Product Lifecycle Management (PLM)

Senior Specialist - LIMS Administration

Costing

Quality Assurance Specialist/Engineer

Sr. Manager / DGM-Costing & MIS

FPGA Engineer

Downstream Pricing Data Analytics

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

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