(Pharmaceutical Manufacturing) Dublin South West.
Suitable candidates will have a 3rd Level engineering degree in Science or Engineering Technology and have a minimum of 3 to 5 years experience working as a Project Manager in Technology Transfer in a GMP Pharmaceutical manufacturing plant.
This a fantastic opportunity to Coordinate and Lead Manufacturing Science & Technology / New Solutions Engineering activities related to Manufacturing Science & Technology / New Solutions Engineering and New Product Induction Projects.
Overall General Qualifications and Experience required:
- Third level qualification to at least degree level in science or engineering-related discipline.
- Ideally 1-2 years’ experience within the pharmaceutical industry, relevant GMP exp & 3-5 years Tech transfer experience.
- Effective project management skills, PMI qualification.
- Good organisational/administrative skills.
- Effective communication and presentation skills in one-on-one and group situations.
- Proficiency in using Microsoft Word, Excel, PowerPoint and MS Project
- Experience in equipment procurement, installation and qualification.
- Ability to understand manufacturing processes, and to identify issues and improvements.
- Skills to prepare written protocols, procedures and reports.
- Ability to handle various responsibilities simultaneously.
- Self-directed and self-motivated.
- To support MSAT NSE activities associated with the development, selection and implementation of new pilot-scale or full-scale equipment/technologies for the production of new topical products or formats.
- Provide technical expertise on the development of the manufacturing process, equipment selection, functionality and definition of critical quality attributes. Activities will include: Manage or participate in the identification and implementation of new technologies, as required for new or existing products
Evaluate proposed changes to equipment or filling/packing processes in relation to the impact on the product quality, safety, efficacy, stability, performance on-line or waste reduction.
- Manage or participate in the identification and implementation of new technologies, as required for new or existing products.
- Evaluate proposed changes to equipment or filling/packing processes in relation to the impact on the product quality, safety, efficacy, stability, performance on-line or waste reduction.
- Work with key stakeholders and equipment suppliers to help identify and eliminate variables in their processes that lead to quality issues and downtime.
- Evaluate component functionality, machine compatibility and performance on-line, including the coordination of technical trials.
- To plan, manage, co-ordinate and design the ‘front-end’ design of the project whilst evaluating quality, value engineering and design for Manufacture (DFM) principles
- To source, select, procure, inspect, approve and oversee installation and qualification of equipment, machines and systems associated with the execution of MSAT NSE projects
- Preparation of equipment specifications, budget estimates, scope documents, IA submittals, purchase requisitions, cost control data sheets, meeting minutes and circulation of same
- Prepare and review documentation relating to equipment or processes associated with NPI projects, e.g specifications, regulatory documents, validation documents, test protocols, URS’s etc.
- To oversee and control drawing and documentation updates to ensure drawings are registered, prepared, checked, approved, circulated and controlled as per relevant procedures.
- To ensure that all work carried out in MSAT NSE is to the highest standard and is in compliance with Safety and GMP standards. Manage and control contractors working on site, ensuring that work practices comply with the relevant regulations, Standards, and cGMP.
- Ensure all AWP’s and contractor management procedures are followed
- To ensure decisions, work practices or use of certain contractors do not expose the company to the risk of poor quality.
- To act as the capital investment lead for NPI projects.
For Further information or to apply please contact: Tom Doyle at kppm in Dublin on: 086 8205038 Email: firstname.lastname@example.org
or email email@example.com
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