Cpl are working with our client partner who are a global pharmaceutical manufacturing company based in Dublin 15 to support them with the recruitment of a Manufacturing Specialist. (this role is day shift Monday to Friday only)
They company are a heritage brand in the pharma industry and their portfolio includes –
Specialty Pharmaceuticals, Active Pharmaceutical Ingredients, Specialty Generics, Pain Medications, Autoimmune and Rare Diseases, Neonatal Respiratory Critical Care, Hemostasis Products, and Extracorporeal Photopheresis
Due to ongoing growth in the Dublin 15 plant, they are now seeking to recruit in a Manufacturing Operations Specialist.
The ideal candidate will have a 3rd level or similar qualification in a Science or Chemistry related discipline. The role itself is an ideal opportunity for someone with a minimum of 1 year’s industry experience and who is looking to continue their professional development in the Pharma manufacturing sector.
Based in the API and Pharmaceutical Manufacturing Department, the job will involve a variety of processing duties in a fast-moving technical environment.
This role is a mix of both “Raw Material Dispensing, Product and Batch Blending.
You will spend about 70% of your time in a Class A clean room manufacturing suite, and the other 30 of the time you’ll be working on CAPA’s, Compliance, SOP review and generation, preparing batch manufacturing documentation etc…
Job Duties and Responsibilities of the position
Ensure compliance of manufacturing operations with relevant regulations and standards associated with cGMP including data integrity, ISO 14001, EMAS, Health & Safety Legislation and Environmental Legislation.
Timely and comprehensive reporting of all hazardous occurrences, incidents, deviations & abnormal occurrences.
Ensure compliance of manufacturing operations with all site standards, policies, and procedures. Knowledge of these standards must be kept up to date using site training programs.
Ensure that the production plants are operated to optimum efficiency.
Provide input and support for continuous improvement initiatives in Manufacturing and other areas as required, includes identifying opportunity for improvements in efficiencies, operations, and procedures.
Closely monitor the operation of the plant and process both in the field and from the plant control systems to ensure compliance with process requirements.
Perform all activities/operations as required and defined in the relevant documentation (e.g. SOPs, MIR).
Prepare ingredients and processing requirements for batches and load prescribed quantities to batches.
Complete inline filter change outs where required or as directed by the Team Leader/Senior Operator.
Calibrate Manufacturing instruments in line with current procedures and as directed by the Team Leader/Senior operator.
Actively participate in training programmes and continuous improvement or other initiatives as directed by the Team Leader.
Participate in the preparation and update of Manufacturing SOPs or Manufacturing related documentation as directed by the Team Leader.
Support inter manufacturing campaign cleaning and product changeovers including the completion of all associated tasks as set out in the CIR (This will include confined space vessel entries as required)
Ensure daily scheduled activities are complete, this may require unforeseen flexibility around the site core business hours. Batches must be progressed to a safe holding point before activities are concluded.
The successful applicant must possess the following knowledge, skills, qualifications, attributes, and experiences.
You will have a minimum of 1 year’s previous experience working in bulk pharmaceutical manufacturing or bulk chemical is a necessity for this job (HPRA/FDA approved), with in-depth understanding of cGMP Quality systems and their implication in a manufacturing context.
Further education in a related field, preferably a Higher Cert in Pharmaceutical Science.
Experience of Bulk Product or Pharmaceutical Batch or API manufacturing, with sound knowledge of related machinery and their operations is a key requirement.
You will have demonstrated ability to troubleshoot and identify technical issues and follow up with corrective actions.
The ability to work in a team environment where individuals often set priorities and complete work activities with minimal supervision.
Demonstrated ability to work with short timelines and meet strict deadlines.
Demonstrated ability to write SOPs relating to the operation (ideally with proven experience of same)
OpEx/LSS certification to White Belt or above would be an advantage.
If you have 1+ years’ experience in GMP Pharma or related manufacturing and you are interested in a move, please send your CV to email@example.com and I’ll reply back to you within 24 hours.