Senior Product Analyst

Senior Software Engineer 2

Quality Technician

Senior Quality & Reliability Engineer

IBM Infosphere DataStage Developer

Technical Writer

Senior Frontend Engineer

Validation Manager

Manager – ADL GMP

Senior Consultant – Commercial Solutions

Responsibilities: <ul><li>Elicit, analyze, and translate user needs into detailed, actionable requirements for the pod</li><li>Define and manage use cases, user stories, process flows, and visualizations to support development</li><li>Partner with design and engineering to explain functional requirements and continuously improve user experience</li><li>Maintain a backlog that stays 2–3 sprints ahead, ensuring clear Definitions of Ready and Done for all features</li><li>Communicate product vision and requirements effectively to developers, testers, and stakeholders</li><li>Support User Acceptance Testing by writing UAT scripts and participating in testing cycles as needed</li><li>Document confirmed business processes to serve as reference for development and IT support teams</li><li>Apply business process improvement methodologies to optimize workflows and system efficiency</li><li>Collaborate closely with the Product Manager to ensure backlog priorities align with business objectives</li><li>Track delivery metrics and build reports to measure progress, quality, and outcomes</li><li>Manage cross-pod dependencies in partnership with the Technical Product Manager</li><li>Ensure compliance with applicable standards by maintaining SDLC documentation, system configurations, and audit artifacts</li><li>Maintain a strong understanding of the IT application portfolio, developing deep expertise in specific products or BPM domains</li><li>Support and facilitate system demonstrations, including Inspect &amp; Adapt workshops, as required</li></ul> Requirements: <ul><li>Proven knowledge and understanding of standard practices, technology and supporting industry principles</li><li>Experience gathering requirements and translating into a product vision by leveraging their expertise in product development, engineering and UX</li><li>Deep understanding of business/processes and high-level understanding of high-quality digital product delivery</li><li>Experienced in managing a product backlog/release plan, tracking team level metrics, attend product team ceremonies, removing blockers (burndown chart, release burn up, etc.)</li><li>Experienced in developing systems and tools to enable customer interactions and collaboration (e.g., digital self, precision marketing, DAM, immersive technology)</li></ul>

Responsibilities:&nbsp; <ul><li>Lead and own the architectural design of the cloud platform, ensuring solutions align with scalability requirements and long-term business objectives.</li><li>Define and execute the technical roadmap in collaboration with cross-functional stakeholders to advance the product vision.</li><li>Translate complex business requirements into clear technical specifications, actionable milestones, and high-quality deliverables.</li><li>Drive engineering excellence by proactively managing functional and non-functional requirements, and initiating corrective action when outcomes diverge from expectations.</li><li>Mentor and develop engineers through structured design, code, and operational reviews, fostering a culture of continuous improvement and technical rigor.</li></ul> Requirements: <ul><li>Experience: 10+ years of software development experience, with at least 3+ years in a technical leadership role.&nbsp;</li><li>Education: Bachelor’s or Master’s degree in Computer Science or a related field.&nbsp;</li><li>Deep Technical Expertise: Extensive mastery of Java, Spring Boot, and SQL.&nbsp;</li><li>Cloud &amp; Distributed Systems: Proven experience designing and operating modern cloud-native, fault-tolerant distributed services (preferably on AWS).&nbsp;</li><li>Architecture: Solid understanding of Microservices and REST API standards.&nbsp;</li><li>Quality Focus: Strong experience in writing Unit and API tests to ensure platform stability.&nbsp;</li><li>Soft Skills: Exceptional strategic thinking and the ability to communicate technical concepts to non-technical stakeholders.</li></ul>

Responsibilities: <ul><li>Ensuring products meet internal and external customer requirements.</li><li>Performing regular inspections and tests on raw materials, in-process components, and finished products using measurement equipment (e.g., calipers, micrometers, and gauges).</li><li>Recording inspection results and maintaining detailed quality documentation.</li><li>Identifying defects and reporting findings to supervisors or engineers.</li><li>Assisting Quality Engineers in resolving quality issues within the production operation.</li><li>Supporting root cause analysis and corrective action activities.</li><li>Complying with Health, Safety, and Environmental Policies.</li><li>Contributing to continuous improvement activities and initiatives.</li><li>Writing reports and providing data to management.&nbsp;</li></ul> Requirements: <ul><li>Experience as an Inspection or Quality Technician.</li><li>Understanding of engineering drawings and quality management systems (e.g., ISO9000, TS16949, ISO 17025).</li><li>Knowledge of statistical tools (e.g., Minitab) and data analysis.</li><li>Strong attention to detail, analytical, and problem-solving skills.</li><li>Ability to interpret technical information and work with minimal supervision.&nbsp;</li></ul>

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

Responsibilities: <ul><li>Design, develop, and implement ETL processes using IBM InfoSphere DataStage to extract data from various source systems, transform it according to business rules, and load it into target data warehouses and data marts.&nbsp;&nbsp;</li><li>Develop and maintain DataStage jobs, sequences, and workflows, ensuring optimal performance and scalability.</li><li>Troubleshoot and resolve data integration issues, working closely with data analysts and other stakeholders.</li><li>Write and execute complex SQL queries to analyze data, profile data sources, and validate ETL processes.</li><li>Collaborate with business analysts and data architects to understand data requirements and translate them into technical specifications.&nbsp;&nbsp;</li><li>Participate in the full software development lifecycle, including requirements gathering, design, development, testing, deployment, and documentation.&nbsp;&nbsp;</li><li>Ensure adherence to data governance policies and standards.</li><li>Monitor ETL processes and proactively identify and address potential performance bottlenecks.</li><li>Contribute to the development and maintenance of technical documentation, including design specifications, mapping documents, and operational procedures.</li></ul> Requirements: <ul><li>Minimum of 3 to 5 years of hands-on experience in designing, developing, and implementing ETL solutions using IBM InfoSphere DataStage.</li><li>Strong understanding of ETL concepts, methodologies, and best practices.</li><li>Proficiency in writing complex SQL queries and working with relational databases, preferably Oracle.</li><li>Experience with data modeling concepts (e.g., dimensional modeling, star schema, snowflake schema).</li><li>Familiarity with Linux operating systems and basic Linux commands is a plus.</li><li>Exposure to OBIEE (Oracle Business Intelligence Enterprise Edition) or other business intelligence tools is a plus.</li><li>Excellent written and verbal communication skills, with the ability to effectively communicate technical concepts to both technical and non-technical audiences.&nbsp;&nbsp;</li><li>Excellent analytical skills and technical skills, with a strong attention to detail and problem-solving abilities.</li><li>Bachelors degree in Computer Science or equivalent in education and work experience.</li></ul>

Responsibilities: <ul><li>Develop and maintain comprehensive documentation for smart contract applications, including user guides, API references, and system overviews.</li><li>Collaborate with engineering and product teams to understand new features and translate them into accurate and accessible documentation.</li><li>Create tutorials, walkthroughs, and FAQs to support users and developers interacting with our applications.</li><li>Ensure documentation is consistent with brand voice, technical accuracy, and usability standards.</li><li>Maintain version control and change logs for documentation updates.</li><li>Organize and manage documentation repositories using tools like Git, Notion, or Confluence.</li><li>Conduct user research and gather feedback to improve documentation quality and relevance.</li><li>Stay current with Web3 trends, tools, and best practices to ensure documentation reflects the latest standards and innovations.</li></ul> Requirements: <ul><li>3+ years of experience in technical writing, preferably in software or blockchain environments.</li><li>Strong understanding of Web3 technologies, including smart contracts, dApps, and blockchain fundamentals.</li><li>Experience documenting APIs, SDKs, and developer tools.</li><li>Proficiency with documentation tools such as Markdown, Git, and static site generators.</li><li>Excellent written and verbal communication skills.</li><li>Ability to work independently and manage multiple documentation projects simultaneously.</li><li>Strong attention to detail and commitment to clarity and accuracy.</li></ul> Bonus Experience: <ul><li>Experience working with smart contracts</li><li>Familiarity with Solidity, Rust, or other smart contract languages.</li><li>Experience with Chainlink tools, including CCIP, Data Feeds, VRF, and Automation.</li><li>Background in UX writing or instructional design.</li><li>Contributions to open-source documentation or developer communities.</li><li>Experience in financial services or regulated industries.</li></ul>

Responsibilities: <ul><li>Create and implement interactive, user-friendly, and visually appealing user interfaces (UIs) for web applications.</li><li>Develop robust front-end architectures, write high-quality code, and perform code reviews to maintain standards.&nbsp;</li><li>Ensure applications are fast, responsive, and scalable across various devices and platforms by optimizing loading times and performance.&nbsp;</li><li>Research, evaluate, and adopt new front-end technologies and frameworks (Angular, React) to keep products at the groundbreaking.&nbsp;</li><li>Collaborate with our team to create user-friendly web3 applications.</li><li>Develop responsive and intuitive UIs with React, Next.js, HTML, CSS, and JavaScript/TypeScript.</li><li>Work with WAGMI, Viem to interact with smart contracts.</li><li>Work with Redux and/or MobX for smooth state management.</li><li>Work with REST APIs and GraphQL for backend communication.</li></ul> Requirements: <ul><li>Proven experience as a senior frontend engineer, with a track record of delivering high-quality web applications.</li><li>Strong proficiency in JavaScript/TypeScript languages.</li><li>Expertise in frontend frameworks: Angular and/or React.</li><li>Hands-on experience with RxJS library and state management systems: NGRX, NGXS.</li><li>Experience in writing and support unit tests (Karma, Jasmine, Spectator).</li></ul>

Responsibilities: <ul><li>Serve as the site Validation SME, overseeing all validation activities, including process, cleaning, equipment, utility, and computer system validation.</li><li>Own and maintain the Validation Master Plan (VMP), ensuring alignment with regulatory expectations, site activities, and company objectives.</li><li>Develop, implement, and maintain the site validation lifecycle program, including process validation, performance qualification (PQ), and CPV.</li><li>Lead validation planning and coordination efforts for new equipment, systems, and process changes in collaboration with Engineering, Manufacturing, and Quality.</li><li>Manage validation project timelines and resource allocation, ensuring activities support commercial readiness and ongoing operations.</li><li>Review and approve validation protocols, reports, and risk assessments in compliance with FDA, EMA, ICH Q8-Q10, EU Annex 15, and company standards.</li><li>Support and participate in cross-functional risk assessments (e.g., FMEA) related to qualification and validation efforts.</li><li>Ensure validation documentation is complete, accurate, and audit ready.</li><li>Provide guidance and technical expertise during regulatory inspections, audits, and customer assessments.</li><li>Develop and maintain the site’s Continuous Process Verification (CPV) program to monitor validated state and process performance over time.</li><li>Define and monitor KPIs for validation program effectiveness and drive improvements in validation efficiency and compliance.</li><li>Train and mentor staff on validation principles and procedures to build internal capability across departments.</li><li>Ensure change control, deviation management, and CAPA processes integrate appropriately with validation and qualification requirements.&nbsp;</li></ul> Key Stakeholders: Internal: <ul><li>Site Quality, Manufacturing, and Engineering Teams</li><li>Technical Services, Supply Chain, and EHS</li><li>Validation Analysts and Support Staff</li><li>Corporate Validation and Quality Teams</li></ul> External: <ul><li>Regulatory Agencies (FDA, EMA, etc.)</li><li>Equipment and system vendors</li><li>Contract testing laboratories</li><li>Third-party auditors and certifying bodies</li></ul> Requirements; Qualifications / Experience: <ul><li>Bachelor’s degree in engineering, Life Sciences, Pharmacy, or related discipline; Master’s preferred</li><li>Minimum 10-12 years of experience in pharmaceutical or biotechnology validation, with at least 3 years in a leadership or SME role</li><li>Validation of sterile injectable equipment expertise required</li><li>Strong knowledge of FDA cGMPs, ICH Q8–Q10, EU Annex 15, and validation best practices</li><li>Experience with sterile injectable manufacturing, aseptic processes, utilities, and equipment qualification</li><li>Experience with controlled substances and high-potency compounds preferred</li><li>Proven experience supporting regulatory inspections and third-party audits</li><li>Experience with commissioning, qualification, and validation in a startup (greenfield) or expansion environment preferred </li></ul> Skills / Competencies: <ul><li>Strong technical writing and documentation review skills</li><li>Ability to manage multiple projects and prioritize in a fast-paced environment</li><li>Expertise in sterile systems, process validation, cleaning validation, and computer system validation</li><li>Excellent cross-functional communication, influencing, and collaboration skills</li><li>Strong analytical, risk-based decision-making, and problem-solving skills</li><li>Leadership presence with ability to coach and mentor others in validation principles</li><li>Commitment to data integrity, patient safety, and product quality</li></ul>

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>

The RoleTo provide expertise, advice, support, report on, and lead large scale/complex supply chain solution projects that optimises organisational value chain integration and performance, underpinned by supply chain and logistics capabilities. The Senior Consultant is experienced in leading cross-functional teams, conducting analysis, providing recommendations and guidance towards the delivery of strategic multiple large-scale supply chain solutions projects. Expected to work closely with clients to understand their business needs, identify opportunities for improvement and design solutions to optimise their supply chains. Manages and balance the requirements between business objectives and project requirements.&nbsp;Recognise trends, patterns, or themes in complex data, and leverages experience to solve complex problems.&nbsp;Understands the importance of project governance, stakeholder management, commercial models, and managing project teams. Key Responsibilities·&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Grow clients and revenue.·&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Overseer quality of analysis and solution teams outputs ·&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Design the test methodology and success criteria for value-chain improvement solutions across multiple capabilities and regions.·&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Facilitate cross functional business improvement and solutions development workshops.·&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Obtain and document client requirements to enable design of integrated fit-for-purpose business solutions that improve client’s value chain.·&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Support management of prospective client pipeline by evaluating and qualifying solution leads·&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Project team performance management Minimum RequirementsQualifications required&nbsp;<ul><li>B.Eng Industrial or BCom Logistics (Honours) or BCom Supply Chain Management (Honours) [NQF level 7 or higher]&nbsp;</li></ul>Skills and experience required<ul><li class="ql-align-justify">8 - 12 years relevant work experience (operations and/or solution design role)</li><li class="ql-indent-1 ql-align-justify">Applies supply chain management knowledge, solves problems in the supply chain using this knowledge.</li><li class="ql-align-justify">Proven track record of leadership and managing project teams</li><li class="ql-indent-1 ql-align-justify">The ability to inspire, motivate and direct individuals to take ownership of-, and achieve desired outputs.</li><li class="ql-indent-1 ql-align-justify">Establishes an atmosphere of trust and mutual respect between team members. </li><li class="ql-indent-1 ql-align-justify">Clearly articulates a goal and purpose to ensure alignment of team members towards a desired objective.</li><li class="ql-indent-1 ql-align-justify">Manages performance of team members.&nbsp;&nbsp;</li><li class="ql-indent-1 ql-align-justify">Provides performance feedback to team members in a constructive manner</li><li class="ql-align-justify">Proven track record of delivering successful projects</li><li class="ql-indent-1 ql-align-justify">The ability to ensure high standards of accuracy, quality, and service delivery to meet and exceed client expectations.</li><li class="ql-indent-1 ql-align-justify">Applies knowledge, tools, and technical expertise to support value creation, tailoring it to the specific needs of the client.</li><li class="ql-align-justify">Thorough understanding of capabilities offered by our client.</li><li class="ql-align-justify">Understanding of financial and management accounting (commercial models).</li><li class="ql-align-justify">Demonstrated understanding of supply chain costs, cost drivers and cost efficiencies levers.</li><li class="ql-align-justify">Ability to review business analysis process and deliverables in order to recommend improvements.</li><li class="ql-align-justify">Exceptional analytical skills.</li><li class="ql-align-justify">Creating &amp; delivering professional presentations.</li><li class="ql-align-justify">Written and verbal communication, including technical writing skills.</li><li class="ql-align-justify">Time management: comfortable working under pressure with stringent deadlines and complex deliverables. Flexible hours to achieve deliverables (sometimes required to work in addition to/outside of normal business hours).</li><li class="ql-align-justify">Plan, manage and account for own time according to tasks’ priorities with a high attention to detail.</li><li class="ql-align-justify">Self-motivated and proactive.</li><li class="ql-align-justify">Able to think logical and objectively with the ability to be innovative in approach and solution design / problem solving.</li><li class="ql-align-justify">Willingness to travel (predominantly Africa, ad-hoc).</li></ul>

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27 writing Jobs found

Senior Product Analyst

Senior Software Engineer 2

Quality Technician

Senior Quality & Reliability Engineer

IBM Infosphere DataStage Developer

Technical Writer

Senior Frontend Engineer

Validation Manager

Manager – ADL GMP

Senior Consultant – Commercial Solutions

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27 writing Jobs found

Senior Product Analyst

Senior Software Engineer 2

Quality Technician

Senior Quality & Reliability Engineer

IBM Infosphere DataStage Developer

Technical Writer

Senior Frontend Engineer

Validation Manager

Manager – ADL GMP

Senior Consultant – Commercial Solutions

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