1 to 25 of 34 GMP Jobs

data flow issues. Compliance & Documentation Maintain documentation for MES configurations, SOPs, workflows, validation protocols, and system changes. Support compliance with FDA, USDA, HACCP, SQF, GMP, and internal quality standards. Participate in change management, system testing, validation, and deployment activities. Assist with user training and development of work instructions. Required Qualifications ...

site is audit-ready at all times. Maintain accurate quality records & contribute to the reporting of site quality KPIs. Manage the site's GMP auditing programme & actively participate in the internal audit team. Drive continuous improvement initiatives that enhance product quality, food safety and operational performance. Ensure Health & Safety, Hygiene ...

Microsoft 365 Group Policy Software Deployment and Release Management Desirable Experience Experience working within pharmaceutical, biotechnology, life sciences, or other regulated industries. Exposure to GMP, GxP, or validated environments. Experience supporting device refresh, Windows 11 migration, or large-scale workplace transformation programmes. Familiarity with application validation and compliance-driven change ...

less experienced engineers Desirable Experience Chartered Engineer status or working towards CEng Experience within pharmaceutical, medical device or other regulated environments Knowledge of GAMP, GMP and ISO standards Cross-disciplinary knowledge across mechanical, electrical and software engineering Experience leading small projects or engineering teams Why Join? This is an opportunity ...

. Participate on cross-functional continuous improvement teams; occasional travel to other sites may be required. Follow all safety protocols and Good Manufacturing Practices (GMP) and adhere to company policies and recognized best practices. Execute a robust preventive maintenance program and maintain accurate maintenance records. Install, maintain, and calibrate industrial ...

development of medicines that improve patients' lives worldwide. Job Responsibilities Main Duties include: Provide data science support as ARD Digital Transformation team partners with GMP-Analytics, Drug Substance (API) and Drug Product (DPA), and Degradation Science and Structural Elucidation (DSSE) teams to digitise laboratory workflows. Partner with Data Science teams ...

system. Participate in daily maintenance meetings and continuous improvement initiatives. Assist with root cause analysis and equipment reliability projects. Maintain high standards of housekeeping, GMP and health & safety compliance. Ensure equipment is operating safely and efficiently to minimise downtime. Experience/Skills/Knowledge/Qualifications: Strong electrical maintenance background ...

system. Participate in daily maintenance meetings and continuous improvement initiatives. Assist with root cause analysis and equipment reliability projects. Maintain high standards of housekeeping, GMP and health & safety compliance. Ensure equipment is operating safely and efficiently to minimise downtime. Experience/Skills/Knowledge/Qualifications: Strong electrical maintenance background ...

collected for testing schedules and testing schedules are met Logging micro samples Accurate carrying out of positive release checks for all finished products GMP audits/Glass and plastic audits, including generation of improvement areas, completing database Ensure close outs of non-conformances Sampling and recording of finished product shelf ...

related field 3+ years experience in Control Systems Engineering Hands on experience with DCS systems (ideally Siemens SIMATIC PCS7) Previous work experience in a GMP manufacturing environment (Pharmaceutical experience is desireable) Knowledge of GAMP frameworks Willing to work on customer sites across the Northwest Code: INDENM If you are interested ...

solutions on time and in line with best practices, project assurance criteria, and audit requirements. Overseeing and managing requests such as Government Dashboard Automation, GMP equalisation (GMPe), and updates to scheme calculations and documentation. Collaborating with colleagues from our Gallagher Centre of Excellence in Pune, India. Testing and implementing system ...

within a QA, Quality Assurance, or Quality Control role. Experience within the food manufacturing industry is essential. Good understanding of HACCP, Food Safety, and GMP standards. Strong attention to detail and excellent record-keeping skills. Confident communication skills and ability to work collaboratively. Ability to work independently and make informed ...

sensors, relays and control systems. Complete maintenance records using SAP/CMMS. Support continuous improvement and reliability projects. Ensure all work is completed to GMP, food safety and health & safety standards. Requirements Time-served Electrical Engineer or equivalent qualification. Strong electrical fault-finding experience in a manufacturing environment. PLC troubleshooting ...

manufacturing automation systems such as DeltaV, PI Historian, PLC, or Lab Automation Systems. Strong knowledge of GAMP 5, FDA 21 CFR Part 11, EU GMP Annex 11, risk-based validation, and CSA principles. Solid understanding of the Software Development Life Cycle (SDLC), Change Management, and Deviation processes. Proven experience supporting … capital projects and Good Manufacturing Practice (GMP) computerized systems. Strong stakeholder management and communication skills. Ability to work independently across multiple projects and sites. Benefits: Our Benefits Include: Medical, Dental, and Vision Insurance 401(k) Retirement Plan Health Savings Account (HSA) Disability Insurance (Short-Term and Long-Term) Life ...

enterprise, laboratory, and quality systems within a regulated pharmaceutical or biotechnology environment. Strong knowledge of GAMP 5, FDA 21 CFR Part 11, and EU GMP Annex 11. Strong knowledge of risk-based validation and CSA principles. Strong knowledge of Software Development Lifecycle (SDLC) processes. Strong knowledge of change management … deviation processes. Experience supporting capital projects and Good Manufacturing Practice (GMP) computerized systems. Strong stakeholder management and communication skills. Ability to work independently across multiple projects and sites. Ability to commute to the site in Rahway, NJ approximately three days per week. Benefits: Our Benefits Include: Medical, Dental, and Vision ...

support the factory QA team, ensuring effective shift coverage, clear responsibilities and opportunities for professional development. Championing food safety: Maintain robust standards across HACCP, GMP, allergen management, hygiene, traceability and product integrity, ensuring compliance with legislation and customer requirements. Driving continuous improvement: Analyse quality performance, investigate complaints and non-conformances … bring: Experience within Quality Assurance or Technical functions in food manufacturing, ideally within chilled food production. A practical understanding of food safety legislation, HACCP, GMP, allergen management and quality risk assessment. Experience of leading, coaching or developing colleagues, with the confidence to provide clear direction and constructive feedback. Knowledge ...

presenting initiatives to the Site Leadership Team, and owning approved projects from analysis through solution build, training, implementation, and sustainment while ensuring compliance with GMP and FDA requirements. Responsibilities: Personally perform process studies, time studies, waste assessments, and bottleneck analysis to identify improvement and automation opportunities. Develop evidence-based opportunity … duplicate reporting or double counting. Establish process ownership, standard work, training, controls, documentation, and performance tracking before project closure. Ensure all improvements comply with GMP, data integrity, safety, quality, change-control, and validation requirements in an FDA-regulated environment. Candidate Profile: The candidate will be a hands-on Continuous Improvement ...

wider Technical Operations Group to turn science and data into compliant, reliable supply. You may also lead equipment and facility qualification for GMP-relevant equipment using DQIQOQ, ensuring systems are designed, installed, operated and perform, and continue to perform as intended. What youll do Lead PPQ: author/approve protocols … oversee execution, analyse data, and issue PPQ summary reports for timely release Lead or participate in equipment and facility qualification: Deliver qualification lifecycle for GMP-relevant equipment using DQIQOQ-PQ and maintain equipment in validated state through periodic review and scheduled requalification, aligned to site procedures and Annex 15 expectation ...

standards. Working closely with cross-functional teams, you'll oversee key quality activities, support continuous improvement initiatives, and play a vital role in maintaining GMP compliance across the site. Key responsibilities include: Lead and support the QA team, providing coaching, training and day-to-day guidance. Ensure quality activities … completed in line with GMP, compliance and business requirements. Review batch documentation and support product release activities. Oversee investigations, deviations, CAPAs and change controls, ensuring issues are resolved effectively. Monitor quality performance and drive continuous improvement initiatives. Manage customer and product quality complaints, ensuring thorough investigation and resolution. Deliver ...

experience in backend development and coding practices. Roles/Responsibilities: Serve as a Quality SME for SAP QM and Digital Quality solutions translating GMP business needs into system requirements and process improvements Support SAP QM incident management, sustainment, and solution releases Drive standardization and optimization of quality processes (e.g., material … supporting implementation of corrective actions as needed. May assist with compliance audits as required. Basic Qualifications: 6+ years of relevant experience in a GMP environment related field and a BS or BA. (computer science) OR 4+ years of relevant experience and an MS. Preferred Qualifications: Prior experience in pharmaceutical ...

identify opportunities, develop business cases, quantify benefits, and build practical workflows, dashboards, or data tools. Strong project ownership and effective cross-functional execution within GMP, data-integrity, safety, and quality requirements. Looking for a candidate with deeper manufacturing automation and continuous improvement execution experience who can independently identify, drive … duplicate reporting or double counting. Establish process ownership, standard work, training, controls, documentation, and performance tracking before project closure. Ensure all improvements comply with GMP, data integrity, safety, quality, change-control, and validation requirements in an FDA-regulated environment. Experience: 2-3 years of pharmaceutical industry experience is required, including ...

support the achievement of Grade AA BRCGS status. You'll manage non-conformances, customer complaints and corrective actions, drive improvements in good manufacturing practice (GMP), and work closely with production, technical and development teams to embed a strong quality culture. This is an excellent opportunity to influence manufacturing standards, develop ...

technology strategy across manufacturing, laboratories, quality, engineering, warehouse operations, automation, infrastructure, data, cybersecurity, and enterprise platforms. Working at the heart of a highly regulated GMP environment, you will ensure technology investments support operational excellence, product quality, regulatory compliance, patient safety, and long-term digital transformation objectives. This is a highly … digital manufacturing initiatives including MES, electronic batch records, paperless production, laboratory digitisation, analytics, AI, integration, cloud, and edge technologies. Ensure architecture decisions align with GMP, GxP, CSV/CSA, data integrity, cybersecurity, validation, and operational resilience requirements. Develop and maintain architecture artefacts including capability maps, data flows, system landscapes, integration ...

Specialist will play a key role in supporting site validation activities across a range of projects. This is a great opportunity for someone with GMP validation experience looking to build on their existing knowledge within a supportive and expanding team. Candidates with equipment or process validation experience from pharmaceutical … other GMP-regulated manufacturing environments are encouraged to apply. The role: Plan and execute validation activities in line with site validation plans and project timelines. Author and maintain validation protocols and reports across multiple validation areas such as: Cleaning validation Computerised systems validation Equipment and utilities qualification Process validation Interpret ...

Provide technical support, troubleshooting, and ongoing maintenance for QC laboratory electronic systems. Manage and maintain master data to ensure system performance remains compliant with GMP and data integrity requirements. Support system enhancements, software updates, new module deployments, and change control activities. Assist with the qualification, validation, and implementation … this role, you will possess: A degree in a scientific discipline, or equivalent industry experience. Proven experience supporting laboratory electronic systems within a pharmaceutical GMP environment. Strong working knowledge of LIMS and/or CDS platforms, including master data management. Excellent communication skills with the ability to explain technical concepts ...