Packaging Operations Lead

Dublin Engineering & Life Sciences

Ref: 11820

An established global pharmaceutical with multiple global manufacturing facilities have recently established a virtual global supply chain and have recently launched and developed multiple branded products . As part of this new external manufacturing structure they are currently developing a pipe-line of innovator products in bio-pharma and they need to recruit new global technical operations team to develop and launch biotechnical products into global markets. As a result of this expansion they are looking to recruit an experienced packaging engineer to manage the efficiency of packaging contract manufacturers: This role with report into a Director of Technical Operations and will be responsible for managing the operational efficiency of the packaging CMOs This individual with need to have an in-dept knowledge of packaging manufacturing across a wide range of products. Another focus of this role will be to work closely with contract manufacturers to improve the efficiency of the packaging lines and to manage any new product introductions in a timely manner as the organization continues to expand their product portfolio. This role will require the individual to over see the maintenance and efficiency of all packaging operations within the contract manufacturers. Experience Required Degree qualification with 5-7 years packaging experience within pharma or biopharma manufacturing Experience of drug product packaging is essential. The Next Step for you: Should this position be of interest to you please forward your CV to Sarah Mac Mullan from Next Generation Recruitment or alternatively call on the main line on 00 353 1662 9120 Next Generation are specialists in Engineering, Data Science, Digital, Finance, IT Contract, IT Permanent, Life Sciences, Supply Chain, Procurement and Operations Applications are in strict confidence. Next Generation will never share your data outside of our organisation without your prior written consent; all our calls are recorded for training and quality purpose. Please read our Data Protection Policy on our website. .

Health & Safety Manager - FMCG

Roscommon Engineering & Life Sciences

Ref: 11756

Health & Safety Manager - FMCG Ready to move into your next role as a Health and Safety Manager in the food manufacturing industry? Then look no further, I have the perfect role for you! This is a one of a kind job in a fast paced and constantly growing food manufacturing company. Their team is growing and they need someone like you to join them and ensure that the factory maintains its high levels of health & safety practices already instilled. You will be reporting into the Assistant Site Manager and you will ensure compliance with all applicable regulatory & statutory requirements. This is a permanent (full-time) job based in County Roscommon. What will you do in this job? You will assist Group Safety Managers in undertaking risk assessments for all operations on site. You will implement and oversee internal audit processes and measure performance and action planning. You will liaise with the HSA and other outside agencies in relation to H&S matters, including reporting, auditing and ensuring recommendations and guidelines are fully complied with. You will ensure ongoing development and implementation of improved Health & Safety practices, policies and procedures on the site. You will undertake regular unscheduled safety audits on the site to ensure compliance with group policy. You will develop and budget with the assistant site manager, effective training policies for implementation on site. What do you need to be successful in this job? You have 5+ years of experience in Health & Safety. You have a degree or qualification in Health & Safety. You have knowledge of H&S legislation as well as Bord Bia & HACCP requirements. You have prior experience of audits and visits. You have a strong personality, excellent communication skills and you are able to keep up within a fast pasted and rapidly growing environment. If you happen to have experience in the food industry, that would be amazing, but that's not a deal breaker if you don't. What's in it for you? A competitive salary with incentives. Time to rest, with 20 days of paid annual leave. And... much more! The Next Step for you: Interested in this role? Please send your CV to SIMONA MORELLI at Next Generation Recruitment by clicking on the Apply button! Not ready to apply just yet? Meet with our recruiters here or get some inspiration to update your CV there. Next Generation specialise in Life Science, Engineering, Supply Chain & Operations, Data Science, Digital Marketing, and IT. Next Generation will never share your data outside of our organisation without your prior written consent; all our calls are recorded for training and quality purpose. Please read our Data Protection Policy on our website.

Associate Director - Analytical AS&T

County Dublin Engineering & Life Sciences

Ref: 11822

Associate Director - Analytical AS&T Ready to move into your next role as an Associate Director - Analytical AS&T and looking to grow your career further within an expanding Biopharma? Look no further, this is the job for you! This is a permanent position based in Dublin. The key aim for the successful candidate will be to develop and mentor a team to support process analytical, QC and manufacturing. You will contribute to site investigations, troubleshooting and lead site analytical technical transfers. Responsibilities Lead the strategic direction of the Analytics team while providing analytical site support Develop and mentor the analytical team SME for technical transfers of analytical methods Define strategies that are scientifically sound, appropriate and incorporates industry and Health Authority best practices and expectations Provide advise to support method robustness Gather and interpret QC data Write and review technical protocols and reports Work collaboratively across organization and sites for in-process method readiness, transfer, performance and troubleshooting Manage scientists involved in technical support, investigations, and process analytics Experience: Minimum BSc. in a scientific related discipline Minimum 8 years' experience in a QC/Analytical/Process role Demonstrated experience in method transfers, validations Previous experience with Biological assays or Process developemnt is essential The Next Step for you: Interested in this role? Please send your CV to Emma Wickham at Next Generation Recruitment by clicking on the Apply button! Not ready to apply just yet? Meet with our recruiters here or get some inspiration to update your CV there. Next Generation specialise in Life Science, Engineering, Supply Chain & Operations, Data Science, Digital Marketing, and IT. Next Generation will never share your data outside of our organisation without your prior written consent; all our calls are recorded for training and quality purpose. Please read our Data Protection Policy on our website.

Senior Professional, Quality Support

Dublin Engineering & Life Sciences

Ref: 11798

Senior Quality Professional - Compliance Are you a Quality professional with 4+ years experience in quality and ready to move into your next role? Then look no further, I have the perfect opportunity for you within a leading Pharmaceutical organisation. This is a permanent job based in Dublin. What will you do in this job? Co-ordinate regulatory activities including site master file, licences, declarations, desk top audits and other regulatory support. Manage and participate in GMP inspections by partners and regulatory authorities. You will be actively supporting the development/implementation and continuous improvement of the Quality Management Systems on site. Project lead for quality initiatives on site. Manage and deliver site wide GMP Training Policy & Programmes. You will be collating information and assisting in the preparation of reports in relation to Annual Product Quality Reviews for all products manufactured on site. You will be supporting change control process as required. What do you need to be successful in this job? You have a third level qualification in Science related discipline You have 4+ years of experience within quality in the Pharmaceutical industry The Next Step for you: Interested in this role? Please send your CV to Emma Wickham at Next Generation Recruitment by clicking on the Apply button! Not ready to apply just yet? Meet with our recruiters here or get some inspiration to update your CV there. Next Generation specialise in Life Science, Engineering, Supply Chain & Operations, Data Science, Digital Marketing, and IT. Next Generation will never share your data outside of our organisation without your prior written consent; all our calls are recorded for training and quality purpose. Please read our Data Protection Policy on our website.

EHS (Process) Engineer

County Dublin Engineering & Life Sciences

Ref: 11737

Are you the EHS (Process) Engineer we are searching for? If you are a spectacular EHS (Process) Engineer who wants to take the next step working at an amazing company then keep reading! This is a permanent (full-time) job based in Dublin. What will you do in this job? Develop and lead the Process Safety Programme on site to define the company's best practice for individual operations/engineering design with respect to process safety/ATEX and machinery safety, and industrial hygiene requirements. Develop and lead HAZOP/process risk assessments plan for the Bulk Business Unit. Support the engineering department in the application of Process Safety elements as per the project development stages for both capital Projects and New Process Introduction and development of EHS related project handover documentation. Lead and support on site audits, to ensure that the company are compliant with applicable process safety requirements, ISO Standards and global programmes/policies. Champion a culture of process safety excellence; managing and eradicating EHS operational risks and hazards to ensure an accident/hazard free work environment. Responsible for continual improvements on the company's environmental footprint and increase sustainability. Collaboratively work with specific departments to provide instruction and training to supervisors on EHS programme initiatives. What do you need to be successful in this job? Degree in Chemical Engineering 3-5 years experience in industry, preferably pharmaceutical Demonstrated experience in process safety and process safety management systems is required What's in it for you? A competitive salary with incentives/bonus. Time to rest, with 25 days of paid annual leave. Free onsite parking. Subsidised canteen. And… much more! The Next Step for you: Interested in this role? Please send your CV to Nicole Tianihad at Next Generation Recruitment by clicking on the Apply button! Not ready to apply just yet? Meet with our recruiters here or get some inspiration to update your CV there. Next Generation specialise in Life Science, Engineering, Supply Chain & Operations, Data Science, Digital Marketing, and IT.

Global Director Technical Operations

Dublin Engineering & Life Sciences

Ref: 11811

An established global pharmaceutical with multiple global manufacturing facilities have recently established a virtual global supply chain and have recently launched and developed multiple branded products. As part of this new external manufacturing structure they are currently developing a pipe-line of innovator products in bio-pharma and they need to recruit new global technical operations team to develop and launch biotechnical products into global markets. As a result of this expansion they are looking to recruit a Global Director Technical Operations to develop and scale up the organization’s global contract manufacturing base This role with report into a global VP External Manufacturing and will be primarily focused on developing and scaling up the technical and operational delivery of the organization’s global contract manufacturers across drug product ,drug substance and packaging as the organization scales up their commercial product portfolio. This role will require the individual to work closely with senior leadership with commercial supply chain and quality functions within the external manufacturing group to ensure all product launches are met in a timely manner and there is no disruption to market supply of new and existing products due to lack of operational delivery by the contract manufacturers. This role will manage a cross functional team from operations, technical and engineering functions who play a key part in the scale up of the operational efficiency across all contract manufacturers and that all tech transfer and launches are handled in effectively. Experience Required Degree qualification with 10-15 years manufacturing and technical operations experience within pharma or bio-pharma sector. Strong drug product and packaging manufacturing experience would be a distinct advantage. Lean manufacturing and operational excellence experience is required. The Next Step for you: Should this position be of interest to you please forward your CV to Sarah Mac Mullan from Next Generation Recruitment or alternatively call on the main line on 00 353 1662 9120 Next Generation are specialists in Engineering, Data Science, Digital, Finance, IT Contract, IT Permanent, Life Sciences, Supply Chain, Procurement and Operations Applications are in strict confidence. Next Generation will never share your data outside of our organisation without your prior written consent; all our calls are recorded for training and quality purpose. Please read our Data Protection Policy on our website. .

Quality Specialist - Audit Management

Dublin Engineering & Life Sciences

Ref: 11810

Quality Auditor Ready to move into your next role as a Quality Auditor? Look no further, this is the job for you! This is a permanent position and with remote working options. The successful candidate will be part of the Development & External QA Operations group. Responsibilities Develop and manage the Clinical Phase and Commercial Contractor Quality Management Program Develop and Manage the internal auditing program for External Operations Manage additional auditing personnel and perform vendor audits, and other qualification activities Management and maintenance of the contractor and clinical phase suppliers GMP Approved Supplier List including the audit schedule Support of Quality/Technical Agreements, External Service Agreements Auditor training with a focus in data integrity auditing; qualifying auditors and SMEs for external auditing Troubleshoot issues, develop and implement effective risk mitigation strategies as required Experience required 8+ years’ experience in a Quality Assurance role Certified Quality Auditor is advantageous Expert knowledge on regulatory requirements and industry expectations for Vendor / supplier Quality Management Working knowledge of US and European Drug Product GMP requirements *Ability to travel up to 40% of the time* The Next Step for you: Interested in this role? Please send your CV to Emma Wickham at Next Generation Recruitment by clicking on the Apply button! Not ready to apply just yet? Meet with our recruiters here or get some inspiration to update your CV there. Next Generation specialise in Life Science, Engineering, Supply Chain & Operations, Data Science, Digital Marketing, and IT. Next Generation will never share your data outside of our organisation without your prior written consent; all our calls are recorded for training and quality purpose. Please read our Data Protection Policy on our website.

QP

Dublin Engineering & Life Sciences

Ref: 11808

An excellent opportunity has just opened up for a QP within leading Global Biopharmaceutical organisation based in Dublin.The successful candidate will be part of a team responsible for the certification of externally manufactured products to be released to the EU/EEA and ROW markets. Responsibilities: QP within the quality release team Review and approval of SOPs, LPRs etc. Oversight of quality activities Maintaining batch records, leading investigations of deviations and improving change controls Quality batch documentation review and control Quality performance reporting Core competencies: Leadership and communication skills Proficient communicator and collaborator at a variety of levels Proven success working well in a team environment with flexibility to react to changing business needs Demonstrated problem solving and project management skills. Requirements: Bachelor’s degree in a Scientific related discipline 5+ years’ in the Biopharmaceutical/pharmaceutical industry Must be eligible to act as a Qualified Person in accordance with the EU Guide to GMP The Next Step for you… Interested in this role? Please send your CV to Emma Wickham at Next Generation Recruitment by clicking on the Apply button! Not ready to apply just yet? Meet with our recruiters here or get some inspiration to update your CV there. Next Generation specialise in Life Science, Engineering, Supply Chain & Operations, Data Science, Digital Marketing, and IT. Next Generation will never share your data outside of our organisation without your prior written consent; all our calls are recorded for training and quality purpose. Please read our Data Protection Policy on our website.