1 to 25 of 91 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 ❯

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 ❯

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 ❯

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 ❯

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 ❯

We're Looking For Degree in a life science field or relevant experience in quality assurance/quality control. Experience in the pharmaceutical or healthcare industry preferred. Knowledge of GMP requirements for sterile manufacturing (clean room) is desirable or general experience of working within a GMP environment. Familiarity with sterile operations or compounding is a plus. If you're passionate More ❯

in achieving key milestones and progressing towards clinical readiness, positioning IRBM as a major player in driving innovation in the pharmaceutical and biotech fields. IRBM Group also has a GMP - certified Contract Development and Manufacturing Organization (CDMO), ADVAXIA Biologics. ADVAXIA is authorized to produce investigational medicinal products by the Italian National Regulatory Authority (AIFA) and is compliant with the FDA More ❯

basic understanding of computer system validation in the pharmaceutical sector Experience and knowledge of working in a regulated environment, specifically with regards to record retention Knowledge of GCP and GMP with regards to QMS activities Responsible for ensuring that own work complies with GMP, Data Integrity and Good Documentation Practice (GDP) and is undertaken in accordance with applicable procedures Responsible … for ensuring that own training is undertaken in a timely and GMP compliant manner before the task is undertaken Responsible for ensuring that any GMP documentation assigned to me e.g. (but not limited to) Issues, CAPAs, Change Controls, BMRs & audit/inspection actions are closed timely and in a RFT state Job Background Minimum of 3 years experience working in More ❯

client based in South West London on a permanent basis. The ideal applicant will have an in depth pharmaceutical background with a strong knowledge of QMS, EU/UK GMP and EU/UK GDP guidelines. Spanish language skills are essential, at a professional level. Responsibilities Include: Ensure Quality Assurance (QA) business and regulatory requirements are met at all times … by all 3rd party suppliers, service providers and customers and Operational activities are compliant with authorised activities and scope detailed in the clients GMP and WDA licences. Co-ordinate the collation and review of supplier licences and certificates. Ensure medicinal products procured, held and distributed are as authorised by WDA of company, storage premises and customers. Manage authorised activities to … of importation performance monitoring. Qualifications: Degree level in a Life Science subject or equivalent in relevant experience. Knowledge of Quality Management system within a pharmaceutical background. Good understanding of GMP/GDP. Good understanding of pharmaceutical regulation and regulators. Good inter-personal and communication skills. Ability to work under pressure and to tight time deadlines. Excellent attention to detail. Ability More ❯

day-to-day operations with long-term strategic planning. This involves ensuring that advanced instrumentation, automation, and control engineering techniques are implemented across the Barnard Castle Site in a GMP compliant manner to meet both local and global requirements. By integrating robust management practices with strategic initiatives, the site can optimize operational efficiency, maintain regulatory compliance, and achieve sustainable growth. … with maintenance technicians, fostering a collaborative and innovative work environment. System Design and Implementation: Lead the design, development, and implementation of advanced automation systems, including PLCs, SCADA, and DCS. GMP Compliance: Ensure all automation systems and processes comply with Good Manufacturing Practices (GMP) and regulatory requirements. Training and Development: Develop and deliver training programs to ensure staff are proficient in More ❯

intermediate product release while maintaining an efficient service in line with customer demands for the release of manufactured batches. Give advice and assistance across site on a range of GMP topics. May be expected to carry out GMP or corrective training. Review and approve documents as the Quality representative such as SOPs and technical reports. Support validation document review and More ❯

Work Schedule Flex Shifts 40 hrs/wk Environmental Conditions Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Cleanroom: no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair etc allowed, Loud Noises (Equipment/Machinery), Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.) Job Description Position 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 ❯

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 ❯

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 ❯

client's biotechnology start-up facility in North East England. This role offers the opportunity to be part of a high-performing automation team delivering critical systems in a GMP-regulated environment. Responsibilities: Executing FAT/SAT/IOQ protocols including generation of protocols and reports. Design, configure, and support Emerson DeltaV PCS and/or BMS platforms for bioprocessing … qualification, and validation of automation systems in collaboration with CQV and Operations teams. Participate in the development, testing, and deployment of automation changes, and maintain documentation in compliance with GMP requirements. Provide technical input during design reviews, FATs, SATs, and system walkdowns. Qualifications & Experience: Bachelor's degree in Automation Engineering, Software Engineering, or a related field. Prior experience in a More ❯

Looking For: Degree in Food Science, Microbiology, or a related field (or equivalent experience). Experience in a QA role within the food manufacturing industry. Strong knowledge of HACCP, GMP, and food safety regulations. Excellent communication and problem-solving skills. Detail-oriented with a proactive approach to continuous improvement. What We Offer: A supportive and collaborative work environment. Opportunities for More ❯

with global platform projects when needed. Requirements: Bachelor's degree in Life Sciences or Computer Science . Experience or interest in lab equipment, data systems, or automation. Knowledge of GMP and working in regulated environments. Good problem-solving and analytical skills. Strong communication skills in English ; Dutch is a plus. Able to manage multiple tasks and work independently. Practicalities: Location More ❯

internal stakeholders (IT, Facilities, Engineering, Security, and Real Estate) and external consultants, contractors, and OEMs. Develop and maintain package scope, budget, schedule, and quality requirements. Ensure all systems meet GMP/GxP compliance, cybersecurity standards, and pharmaceutical industry best practices. Lead RFP processes, technical evaluations, and contract negotiations for IT/AV vendors and integrators. Manage interdisciplinary coordination with MEP More ❯

internal stakeholders (IT, Facilities, Engineering, Security, and Real Estate) and external consultants, contractors, and OEMs. Develop and maintain package scope, budget, schedule, and quality requirements. Ensure all systems meet GMP/GxP compliance, cybersecurity standards, and pharmaceutical industry best practices. Lead RFP processes, technical evaluations, and contract negotiations for IT/AV vendors and integrators. Manage interdisciplinary coordination with MEP More ❯