Manchester, England, United Kingdom Hybrid / WFH Options
Factorytalk
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 ❯
/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 ❯
Manchester, England, United Kingdom Hybrid / WFH Options
JR United Kingdom
low/no-code tools is advantageous but not essential. Proven track record of leading MES projects from start to finish. Understanding of Pharma/Biotech processes and regulations (GMP, FDA 21 CFR Part 11, GAMP5). Strong problem-solving and communication skills. Willingness to travel to client sites. What We Offer: Competitive salary and benefits. Growth and development opportunities. More ❯
Oxford, England, United Kingdom Hybrid / WFH Options
Moderna
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 ❯
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 ❯
asubject matter expert in automation, ensuring seamless integration of digital manufacturing approaches beyond traditional automation boundaries. Your contributions will support system reliability, performance optimization, and continuous improvement initiatives within GMP-regulated environments. Working under the technical supervision of your line manager and senior technical colleagues, you will ensure regulatory compliance, system validation, and effective automation strategies that align with MMIC … Automation for Pharma strategy into practical deliverables within the Operational Technology ( OT ) team to meet business objectives. Compliance & Documentation: Ensure full compliance with Safety, Health, and Environmental ( SHE ) regulations, GMP standards, and best practices. Maintain clear and documented records of technical data, validation master plans, and experimental testing plans within the MMIC GMP framework. Technical Leadership: Act as arecognized authority … GAMP 5 approach to GxP Computerised System Validation. Knowledge of functional safety systems within automated machinery. Chartered/registered status with arelevant professional institution. Have industrial experience within a GMP environment. What does CPI offeryou? At CPI , we offer awide range of benefits to our employees, this includes: Up to 36 days holiday, including bank holidays - Plus aholiday purchasing scheme 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 ❯
Leighton Buzzard, Bedfordshire, South East, United Kingdom
Marken
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 ❯
You Bring 5+ years delivering MES solutions (Tulip or similar platforms - e.g. Siemens, Rockwell, Koerber, etc.) Strong experience in integration: ERP, lab systems, IoT, machines A practical grasp of GMP, GAMP5, and 21 CFR Part 11 Familiarity with business process mapping from URS to validation Confident working across Fit-Gap, presales, and improvement phases Curious, modern mindset — excited by low More ❯
members, closing skill gaps through tailored training plans. Drive a strong quality culture within QA and operational teams through effective communication and leadership. Quality Compliance & Improvement Maintain and improve GMP standards via auditing, coaching, and root cause analysis. Ensure product specifications and manufacturing procedures meet GMP and customer standards. Manage internal and external audits, ensuring all non-conformances are resolved More ❯
Management Representative relating to the development and continuous improvement of the processes needed for the Quality Management System. Leads external supplier audit and qualification. Requests, reviews, and processes all GMP/GDP documentation as defined in the QTAs. Requirements: Extensive quality experience in the pharmaceutical industry. Previous experience of acting or deputising as a Responsible Person. Experience working with medical More ❯
upholding health and safety policies Support other departments as required. All staff are expected to support the company's commitment to ISO 9001:2015 standards and GoodManufacturingPractice (GMP) as part of our quality management system. #J-18808-Ljbffr More ❯
Out in Science, Technology, Engineering, and Mathematics
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 GoodManufacturing Practices (GMP) and regulatory requirements. Training and Development: Develop and deliver training programs to ensure staff are proficient in More ❯
will also lead efforts in driving adherence to the food safety agenda. Maintain food safety and QMS in line with group standards and retailer requirements Conduct verification activities (QMP, GMP, internal audits) and support investigations Ensure microbiological data is accurately recorded, analyzed for trends, and reports are generated and circulated Conduct routine traceability exercises and lead trace activities during audits … Support investigations of food safety-related customer complaints and issues Maintain site GMP standards, food safety, and quality systems in line with SDUK and retailer standards Maintain BRC accreditation and relevant retailer approvals, including Red Tractor, Halal, and Kosher certifications Demonstrate experience with food safety/quality roles, BRC, and retailer standards and audits Show knowledge of analysis and trend More ❯
Wirral, England, United Kingdom Hybrid / WFH Options
Humdinger
process, and packing checks. Provide coaching and development, closing skill gaps with tailored training plans. Foster a strong quality culture through effective leadership and clear communication. Maintain and enhance GMP standards through auditing, coaching, and root cause analysis. Ensure products meet both GMP and customer specifications. Manage internal and external audits in collaboration with the Technical Manager, resolving non-conformances More ❯
Salford, England, United Kingdom Hybrid / WFH Options
MORGAN SINDALL GROUP PLC
You As Senior/Principal Architect - Life Sciences you will have experience in delivering projects from concept to detailed design in the life science sector for both laboratories and GMPmanufacturing facilities. You will be part of an enthusiastic and committed team of Architects and Technicians who will deliver high quality output on projects. To be successful you will exhibit More ❯
Manchester, England, United Kingdom Hybrid / WFH Options
BakerHicks
You As Senior/Principal Architect – Life Sciences you will have experience in delivering projects from concept to detailed design in the life science sector for both laboratories and GMPmanufacturing facilities. You will be part of an enthusiastic and committed team of Architects and Technicians who will deliver high quality output on projects. To be successful you will exhibit 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 ❯
as met by the Quality team. Provide support to Operations to allow them to operate to the required technical and quality standards whilst maintaining operational efficiency. To monitor audit GMP standards in the factory and ensure corrective actions are taken where necessary to drive standards. Ensure routine internal audits i.e. hygiene, glass and brittle material, foreign bodies and GMP are More ❯