1 to 25 of 223 GMP Jobs

equipment qualifications, process validations, cleaning validations and computer software validations. Previous experience in root cause, corrective action, preventative action and process improvement. Understanding of ISO 9001, Good Manufacturing Practices (GMP), and Good Documentation Practices (GDP) requirements. Travel, Motor Vehicle Record & Physical/Environment Requirements: Ability to travel up to 10% a year. Must have a valid driver's license with More ❯

About the Role We are seeking a seasoned MES Project Manager with deep expertise in PAS-X to lead the design, deployment, and optimization of MES solutions across GMP-regulated manufacturing operations. In this role, you will be accountable for managing complex MES programs, ensuring alignment between business needs, technical implementation, and regulatory requirements. You will serve as the primary … QA, Validation, Engineering, IT/OT, and external vendors. Oversee system configuration, MBR design governance, interface development (e.g., ERP, LIMS, SCADA), and data migration activities. Ensure full compliance with GMP, GxP, CSV, GAMP5, and 21 CFR Part 11 regulations throughout the project lifecycle. Manage project documentation including URS, functional specs, risk assessments, validation protocols (IQ/OQ/PQ), and … field. 5+ years of experience in managing MES projects with a minimum of 3 years dedicated to PAS-X implementations. Proven track record of successful PAS-X rollouts in GMP manufacturing environments (pharma/biotech). In-depth knowledge of PAS-X architecture, MBR design principles, and standard modules (eBR, Equipment Management, Weigh & Dispense, etc.). Strong grasp of GxP More ❯

reliability processes exist for site utility control systems and equipment. Monitor, generate and complete the periodic review, master plan for the automation engineering program. Develop equipment documentation to meet GMP requirements, i.e.: URS, FAT, Equipment IQ/OQ, PM, SOPs. Implement engineering standards and best practices 2) Support Capital Projects and the integration of new equipment/technologies to the … B.S. degree in an Engineering related field. Master's Degree and 2 years of Engineering experience 8+ years of relevant automation/controls experience in pharmaceutical or biopharmaceutical based GMP manufacturing operations Proficient in BAS/BMS programming or mechanical HVAC control experience Experience with one or more of the following platforms: Johnson Controls, Schneider Electric, Tridium Niagara, Honeywell, Rockwell More ❯

as extensive technical training will be provided. Proven experience in leading complex MES projects from concept to deployment. Knowledge and understanding of Pharma and Biotech industry & processes. Familiarity with GMP, FDA 21 CFR Part 11, GAMP5, and other relevant regulatory requirements. Excellent problem-solving, communication, and interpersonal skills. Ability to travel as required to client sites. What We Offer: Competitive More ❯

testing, including communicating testing priorities, review and approval of OOS investigations, and test method maintenance. Oversee and own the process for review and approval of analytical data for future GMP testing of raw materials, in-process materials, and finished drug products. Act as Quality Control during inspections and conferences with FDA, Notified Body, Competent Authority, and other regulatory agencies. Proactively … and ISO compliance. Support company goals and objectives, policies, and procedures. Requirements: B.Sc. in Life Sciences, Chemistry, Chemical Engineering. Minimum 5 years related experience in the pharmaceutical industry supporting GMP testing activities - startup experience a bonus. A willingness to work hard, with a driven outlook and with a strong desire to succeed, as a scientist, as a team, and as More ❯

and industry events. About You You will have extensive experience of leading Quality Improvement initiatives. Competence in investigation, root cause analysis, and risk management strategies. A deep understanding of GMP and Quality Management Systems. Strong leadership skills with the ability to inspire and motivate teams. Competence in investigation, root cause analysis, and risk management strategies. Excellent interpersonal and influencing skills More ❯

solutions, systems and interfaces (API). Agile and hands-on. Team player. Recommended Degrees: Life Sciences or Quality-Focused Fields: These provide strong domain knowledge for regulated environments (GxP, GMP, compliance, etc.). Bachelor's or Master's in: Pharmaceutical Sciences Biotechnology Biomedical Science Information Technology/Computer Science: Essential for understanding systems architecture, interfaces, user support, and configuration. Bachelor More ❯

platform. Mytos is already SOC 2 Type 2 audited, but as our customers move from research into production of cell therapies, they need our technology to be suitable for GMP environments. In this role, you'll be responsible for designing and implementing the infrastructure, processes, and features needed to support cell therapy manufacturing in regulated environments. You'll create elegant … our approach to security, compliance and risk management. Own Mytos' information security program (e.g., SOC 2, ISO 27001) and work cross-discipline to bring the business and product into GMP environments. Develop automated testing and validation strategies that build quality into our development process rather than bolting it on afterward. Streamline our deployment processes enabling both rapid development and stable … Knowledge of relevant standards and compliance frameworks (e.g. ISO 27001, SOC 2, ISO 9001, GAMP 5, FDA 21 CFR Part 11, ALCOA+, BS 10008). Experience with regulated environments (GMP, HIPAA, etc.). Understanding of hardware-software integration. Experience with containerisation and orchestration (Docker, Kubernetes). Experience with Python for tooling or data processing. Background in manufacturing or laboratory automation. More ❯

highest standards for aseptically compounded medicines. Monitor Trends: Investigate trends in quality KPIs, including fails, rework, and complaints, and report findings to management. Promote Best Practices: Educate colleagues on GMP (Good Manufacturing Practices) and ensure compliance. Support Inspections: Assist the Head of Quality Assurance in leading and closing MHRA and Home Office inspections. Strategise for Success: Work with Executive Directors … criteria: Proven experience in a similar role, ideally in aseptic manufacturing A degree in a life sciences discipline (e.g., pharmacy, microbiology, chemistry). At least 5 years of relevant GMP experience within a licensed facility or under a section 10 exemption. Comprehensive, up-to-date knowledge of GMP practices. A self-starter with a demonstrated ability to work autonomously and More ❯

highest standards for aseptically compounded medicines. Monitor Trends: Investigate trends in quality KPIs, including fails, rework, and complaints, and report findings to management. Promote Best Practices: Educate colleagues on GMP (Good Manufacturing Practices) and ensure compliance. Support Inspections: Assist the Head of Quality Assurance in leading and closing MHRA and Home Office inspections. Strategise for Success: Work with Executive Directors … criteria: Proven experience in a similar role, ideally in aseptic manufacturing A degree in a life sciences discipline (e.g., pharmacy, microbiology, chemistry). At least 5 years of relevant GMP experience within a licensed facility or under a section 10 exemption. Comprehensive, up-to-date knowledge of GMP practices. A self-starter with a demonstrated ability to work autonomously and More ❯

closely with Operational Teams to share information and best practices to improve standards. Ensure all Quality Management System standards are followed. Perform label verifications and allergen checks. Conduct site GMP and GHP audits according to schedule for bakery and warehouse. Carry out quality checks and document verification for bakery and warehouse operations. Maintain product inspections, laboratory testing, and generate/ More ❯

/raw material approval, product setup, and incoming material quality control. Additionally, you will support the management of MSC, ASC, and BRC certification standards, ensuring ongoing adherence to quality, GMP, hygiene, and pest control requirements. Your responsibilities also include conducting raw material intake checks, overseeing traceability and labelling accuracy, coordinating sample testing for internal and external assessments, and analyzing results … accountabilities: Continuously improve and enforce QMS through audits, technical support, and consistent system implementation. Support customer, regulatory, and third-party audits (BRC, MSC, ASC) and ensure compliance with quality, GMP, hygiene, pest control, and legal standards. Manage non-conformance investigations, complaints, raw material intake checks, traceability, labelling, and environmental monitoring. Maintain QMS documentation, review artwork and labels, manage product specifications More ❯

for supplier/raw material approval, product setup, and incoming material quality control. You support the management of MSC, ASC, and BRC certification standards, ensuring ongoing adherence to quality, GMP, hygiene, and pest control requirements. Your role also includes conducting raw material intake checks, overseeing traceability and labelling accuracy, coordinating sample testing for internal and external assessments, and analyzing results … accountabilities: Continuously improve and enforce QMS through audits, technical support, and consistent system implementation. Support customer, regulatory, and 3rd party audits (BRC, MSC, ASC) and ensure compliance with quality, GMP, hygiene, pest control, and legal standards. Manage non-conformance investigations, complaints, raw material intake checks, traceability, labelling, and environmental monitoring. Maintain QMS documentation, review artwork and labels, manage product specifications More ❯

bona fide checks on new and existing suppliers and clients. Training & Staff Development: Training staff on SOPs and GDP compliance; Keeping the company updated on changes in GDP and GMP regulations. Complaint & CAPA Management: Investigating customer and supplier complaints or deviations; Overseeing CAPA tracking, implementation, and verification of effectiveness post-implementation. Regulatory Tasks: Preparing and submitting WDA variations, renewals, and More ❯

cash, advertising strategy & sales operations teams needs, challenges and requirements. - Develop strategies to leverage Salesforce Media Cloud for centralizing and monetizing ad inventory across platforms like Google Marketing Platform (GMP); Meta Ads; Criteo and LinkedIn and more. - Provide expert advice on best practices for ad operations, inventory optimization, and revenue growth. * Implementation and Configuration: - Lead the implementation of Salesforce Media More ❯

system architecture. Proven experience in lifecycle management activities. Required experience in pharmaceutical, biological, or bulk-manufacturing facilities. In-depth understanding of the validation lifecycle in a Good Manufacturing Practice (GMP) environment. General knowledge of IT infrastructure, including networking, Windows Server, virtualization, and storage technologies. Experience with Delta V, PI, and PAS-X systems is preferred What we offer We welcome More ❯

floor, or in discussions with digital teams. This individual will support and maintain both the infrastructure and applications used in our manufacturing environment, ensuring seamless operations that adhere to GMP standards. This position is ideal for a highly skilled engineer who thrives at the intersection of IT and OT, switching between systems-level problem-solving and on-the-ground operational … and supporting innovation initiatives, including proximity to Generative AI-enabled tools. Here’s What You’ll Do: Your key responsibilities will be: Ensure uninterrupted performance of systems that support GMP operations, including virtual machines, servers, and critical manufacturing applications. Troubleshoot and maintain infrastructure components such as VMware, Windows Servers, DNS/DHCP, network architecture, and wireless networks in GMP settings. More ❯

Managing non-conformance, complaints, and root cause investigations — implementing corrective and preventative actions. Supporting NPD launches, ensuring new products are introduced effectively and safely onto the factory floor. Overseeing GMP, hygiene verification, and internal audit activity, while contributing to HACCP and site improvement initiatives. Acting as a key support to the Site Technical Manager, including deputising when required. Championing best More ❯

in process control skills, including some of the following: PLC (AB Rockwell, Siemens), SCADA systems (Rockwell Historian), CAD, Trend BMS/Set, Lighthouse EMS, JDEdwards. Experience: Good Manufacturing Practice (GMP) experience. Attributes: Proactive, methodical, and a strong problem solver. Why You Should Join Catalent: Competitive Salary - Reflecting your experience and skills. Bonus & Benefits - Includes an annual performance bonus, a pension More ❯

User Requirement Brief (URB) and User Requirement Specification (URS) with the end customer as required by the project and interfaces with validation. Co-ordination of design reviews, safety studies, GMP reviews and constructability assessments to shape the design and planning process. Preparation of Pre-Construction Information (PCI) for accountable projects as well as client HSE requirements (e.g. F10 notification). More ❯

User Requirement Brief (URB) and User Requirement Specification (URS) with the end customer as required by the project and interfaces with validation. Co-ordination of design reviews, safety studies, GMP reviews and constructability assessments to shape the design and planning process. Preparation of Pre-Construction Information (PCI) for accountable projects as well as client HSE requirements (e.g. F10 notification). More ❯

User Requirement Brief (URB) and User Requirement Specification (URS) with the end customer as required by the project and interfaces with validation. Co-ordination of design reviews, safety studies, GMP reviews and constructability assessments to shape the design and planning process. Preparation of Pre-Construction Information (PCI) for accountable projects as well as client HSE requirements (e.g. F10 notification). More ❯

mechanisms. Front line interface for sandwich quality initiatives. Factory Standards Work with the Factory Operations teams to set clearly defined factory standards. Monitor adherence to these standards through detailed GMP, food safety and finished standards audits. Encourage the principles of continuous improvement. Maintain appropriately managed documentation to support the systems. Internal Audits Support the central compliance audit programme. Monitor adherence More ❯

Key responsibilities: Supporting the Head of QA & RA, QA Managers, Responsible Persons and Qualified Persons with the implementation and maintenance of the Quality Management System in accordance with the GMP and GDP guidelines and GPhC, ISO 9001 and ISO 13485 standards. Supporting the ongoing compliance with relevant standards, legal requirements, regulations and the PSDL documented policies and procedures. Promoting a … of the Quality standards required and able to promote a positive Quality culture within the company. Excellent knowledge of Word, Outlook, Excel, PowerPoint, and Teams. Good knowledge of GDP, GMP and GPhC regulations, ISO 9001 and ISO 13485 standards. More ❯

and embedded analytics for production KPIs Exposure to SAP IBP, PP/DS, or advanced scheduling tools is highly desirable Awareness of industry manufacturing standards and regulatory compliance frameworks (GMP, ISO, etc.) Stakeholder & Soft Skills Strong engagement skills with manufacturing stakeholders: Heads of Production, Plant Managers, and COOs Ability to translate complex operational processes into streamlined SAP-enabled solutions Excellent More ❯