Senior Project Engineer - cell engineer
Independent Solutions
- Limerick
- Contract
- Full-time
Overview:Provide engineering support in developing new or improving existing equipment and/or process related activities. Define or assist in defining process equipment requirements and specifications based on process requirements, client's safety requirements and customer needs.
Key Responsibilities:
- Perform project management tasks for small to medium scale projects involving either new or existing equipment
- Assist in determining the budget to support requirements
- Evaluate or assist in evaluating technology necessary to support requirements
- Propose options to Management/Customer/Stakeholders
- Provide technical support for projects
- Support and/or develop and execute equipment or process related validations in accordance with IML requirements, processes and procedures
- Assist in negotiation with equipment suppliers
- Utilize necessary project tools, i.e. URS, Microsoft Project, etc. to manage projects successfully
- Develop the necessary equipment, process and product knowledge to be recognised as a local expert.
- Measure/evaluate equipment efficiencies, downtime and assist in the development of maintenance requirements
- Propose and implement improvement projects that improve compliance, improve efficiencies, yields or throughputs
- Define root cause and implement solutions to equipment and process related non-conformances utilising the NCMR and CAPA processes
- Actively interfacing with cross-functional team members, always practicing good team work in support of day to day operating requirements
- Ensure effective closure on quality system documents (Audit Action, NCR's, CAPA's, Maps, etc.)
- Implementation of safety/environment requirements on purchase and changes of all new and existing equipment.
- Hold a relevant degree or equivalent qualification in production, manufacturing or mechanical engineering.
- 4 years' experience in relevant engineering role
- Prior experience in a GMP or medical device manufacturing environment
- Prior experience in equipment and process validation activities
- Process development experience
- Familiar with ISO safety standards
- Previous experience in the use of 'black belt' statistical techniques would be a distinct advantage, as would familiarity with equipment validation in a FDA environment
- Have statistical process control and capability analysis using ANOVA and DOE techniques
- Ability to apply a scientific approach to problem solving, blending analytical and experimental skills to maximize productivity and yields is an essential requirement.
- Develop good working relationships across the business
- Ability to motivate and lead - must be team orientated
- Ability to work on own initiative
- Good project management and communication skills.
- Attention to detail
Responsibilities and accountabilities will vary for all positions and the scope of individual roles may not be limited to the contents of this position description. QUMAS procedures will define responsibilities from time to time and each manager is responsible for complying with these processes, which supplant any responsibility outlined within. As such, adherence to company procedures is also a responsibility of any roles encompassed within this Job Description.Benefits:
- Benefit from Independent Solution's ethical principles.
- Pre-interview preparation before attending the interview and help to use STAR technology to answer the questions.
- While placed on client sites you will be an integral part of our team, gaining support and access to the knowledge and experience of our cross-functional Life Science team.
- We offer attractive rates - competitive margins compared to our competitors.
- Payment on time and in full.
- We are recognized as approved suppliers to leading key pharmaceutical and medical device companies.