This role requires an experienced individual with a minimum of 5 years’ (for MSc) or 7 years’ (for BSc) directly related experience in academia, pharmaceutical or biotechnology company – along with a working knowledge of current regulatory requirements and current Good Manufacturing Practices. A self-starter and results-focused, the successful candidate will have strong contemporary knowledge, and the ability to work independently and on multidisciplinary teams. The successful candidate will also have demonstrated the ability to deliver what is needed on-time, holding self and team accountable for commitments, decisions, actions and behaviors. Excellent oral and written communication skills, with the ability to effectively articulate understanding of process science, in order to drive decision making, impact assessments, design of studies, etc., in a multi-disciplinary team environment.
Responsibilities
· Support the design, construction and qualification of upstream & downstream equipment on site through to technology transfer and commercialization.
· Support establishment of the commercial process and routine manufacturing
· Supporting experimental design, execution, data analysis and interpretation.
· Interpreting trends observed in commercial process monitoring (e.g., proactive process analysis (PPA), continued process verification (CPV), statistical process control (SPC) multivariate analyses (MVDA)), and for further technical investigations and process changes that seek to drive improvements to yield and/or robustness.
· Supporting deviation management.
· Supporting change control prioritization and implementation.
· Authoring and reviewing of batch documentation, technical reports and global regulatory submissions.
· Supporting multidisciplinary teams (manufacturing science and technology, quality, analytics, regulatory) for process improvement and troubleshooting with end-to-end product focus.
· Applying LeanSixSigma tools by: Securing continuity of an appropriate LSS/CEM level of knowledge. Facilitating problem solving & risk assessment (FMEA) projects/meetings. Making problems visible and strive for continuous improvement.
· Serving as a key member during internal audits and external inspections/audits
· Lead and support various manufacturing science and technology organizational initiatives as needed (examples include safety, financial forecasting, work standardization, etc).
· Maintain continuous focus on quality and safety compliance and unflinching focus on the customer.
· This role may require shift work support after the facility startup phase is complete.
Experience & Skills
· Experience with upstream cell culture and/or downstream purification of biological molecules.
· Experience with technology transfer, regulatory filing, and commercial drug substance manufacturing of biologics is a plus.
· Technical operations experience in the drug substance manufacture of biological molecules at commercial scale.
· Prior experience in drug substance process development, process characterisation studies, process performance qualification and validation, site readiness, batch record reviews, authoring regulatory CTD sections and/or working with external contract organisation for development and/or manufacturing.
· Working knowledge of statistical methods for DOE design and data analysis (e.g., JMP or Design Expert software)
· Working knowledge of statistical process control (SPC), multivariate analysis (MVDA), and/or process analytical technologies (PAT) techniques for biologics processes
To apply contact Martin Lynch on 087-344 3581.
Email CVs to
Headcount Solutions is currently assisting a leading International manufacturer of cutting-edge air purification equipment. We are now looking for an experienced Senior Manufacturing Engineer to support the process from product design and development, through to manufacturing and production.
Working with the contract manufacturers, you will also be tasked with improving product manufacturing efficiencies. With a facilities across Ireland this position will also lead and support the US operations. You will also be required to work remotely based on the current restrictions.
The products utilize a proprietary ionization technology that provides high tech solutions to the commercial, industrial, and institutional markets.
This position represents an opportunity to join a growing company in an expanding industry and be on the forefront of green technologies.
Position Duties and Responsibilities:
Position Requirements:
For immediate consideration, please contact Andy Litchfield (Dublin, Ireland) – andy@headcount.ie +353 86 0482656
Do you want to work for a vibrant, exciting company operating in one of the fastest growing markets online today?
I am working closely with a leading multinational eCommerce company that provide an online marketplace which allows their users to access a vast range of royal-free digital media content.
Currently undergoing a period of growth, I am looking to speak with a talented, passionate and experienced QA Engineer to join this companies Software QA team in Dublin. The perfect candidate will have excellent testing skills, be detail oriented, and will thrive working in a highly technical environment.
This person will work across various teams using a number of tools and technologies and the company are looking for someone with a proven record in enabling the delivery of quality software and engaging throughout the full SDLC.
Duties of the role:
•Interact with PM and Dev teams to gain a strong understanding of the project and the testing objectives.
•Maintain and expand existing testing documentation for product and solutions.
•Work within an Agile environment (using JIRA).
•Protect the overall of quality, security and performance.
•Execute/analyse manual testing and write, execute, and maintain automated tests using the Robot Framework.
•Setup/maintain test environments.
•Support production deployment of applications.
What you need:
•1 - 3 years' experience in QA (at least 1 year to be within an agile environment).
•Excellent understanding of the full Software Development Lifecycle.
•At least 1 years' experience of automated web application test tools (Selenium, Protractor, Robot, etc).
•Knowledge of databases and writing SQL.
•Exposure to/experience in managing frequent releases.
•Excellent communications skills.
•Exposure to PHP, Postgres, Linux implementations (Desirable).
•ISTQB Certification (Desirable).
Please apply at the link provided or contact me for more information on this role and the fantastic package on offer! Call 087 695 0048 or email niall.gormley@stelfox.com
Please note:
We have a number of similar positions currently, and in the future, which we would like to discuss with you should you indicate your interest in this role. When we receive your application for this role, we will contact you to advise you of our process for other similar positions.
Stelfox is fully compliant with GDPR regulations and you can read more in our privacy policy here: https://www.stelfox.com/privacy-policy-gdpr/
Your shared data will not be disclosed or transferred to a third party data controller or data processor located outside the EEA unless we have obtained your express consent.
We look forward to working with you.
Responsibilities:
Qualifications:
Following your application for this specific role, Sigmar may contact you regarding other positions that we feel you may be suitable for. If you do not wish to be contacted about other opportunities please let us know. For further information please refer to the Privacy Statement on our website.
Headcount Solutions is currently assisting a leading International manufacturer of cutting-edge air purification equipment. We are now looking for an experienced Senior Manufacturing Engineer to support the process from product design and development, through to manufacturing and production.
Working with the contract manufacturers, you will also be tasked with improving product manufacturing efficiencies. With a facilities across Ireland this position will also lead and support the US operations. You will also be required to work remotely based on the current restrictions.
The products utilize a proprietary ionization technology that provides high tech solutions to the commercial, industrial, and institutional markets.
This position represents an opportunity to join a growing company in an expanding industry and be on the forefront of green technologies.
Position Duties and Responsibilities:
Position Requirements:
For immediate consideration, please contact Andy Litchfield (Dublin, Ireland) – andy@headcount.ie +353 86 0482656
IPS is hiring! We are looking for 2 talented Senior Process Engineers to join our industry leading Process Engineering team at our office in Dublin, Ireland.
The Senior Process Engineer is responsible for designing and implementing manufacturing processes, and, supporting utilities on a scale that can range from developmental pilot plant, to full commercial production. In this role we require a candidate who has process design and operations experience in pharmaceutical facilities, which include biologic and organic synthesis Active Pharmaceutical Ingredients.
Job Duties and Responsibilities:
About Us
IPS-Integrated Project Services is a global leader in developing innovative and cost-effective solutions for the engineering, construction, commissioning and qualification of complex pharmaceutical and biotech research and manufacturing facilities. With technical expertise spanning R&D to pilot-scale to large-scale production, our team specializes in the technology, trends and regulatory environment to successfully deliver capital projects and improve operations. For over thirty years, we have applied unique LEAN methodologies throughout the project life cycle, continually finding ways to do things better and more efficiently, delivering higher quality and controlling costs. Headquartered in Blue Bell, PA, IPS is a multi-national company with over 1,450 professionals worldwide and offices in California, Indiana, Kansas, Massachusetts, New Jersey, North Carolina, Pennsylvania, Brazil, Canada, China, Germany, Ireland, Singapore, Switzerland, UK and four locations in India. Visit our website at www.ipsdb.com.
Specialties
Process Architecture, Process Design, Engineering, Construction, Commissioning, Qualification, LEAN Project Delivery, Strategic Master Planning, Energy Conservation Management, Project Controls, Program/Project Management, Operations/Logistics Strategy and Planning, EPCMV and Staffing Services.
IPS is an equal opportunity, affirmative action employer of protected veterans (M/F/D/V).
Attention Search Firms / Third Party Recruiters: IPS is not seeking assistance or accepting unsolicited resumes from search firms for employment opportunities with IPS. Regardless of past practice, all resumes submitted by search firms to any employee at IPS via-email, the Internet or directly to hiring managers at IPS in any form without a valid written search agreement in place for a specific position will be deemed the sole property of IPS, and no fee will be paid in the event a candidate is hired by IPS as a result of the referral or through other means.
Posted
Today
This role requires an experienced individual with a minimum of 5 years’ (for MSc) or 7 years’ (for BSc) directly related experience in academia, pharmaceutical or biotechnology company – along with a working knowledge of current regulatory requirements and current Good Manufacturing Practices. A self-starter and results-focused, the successful candidate will have strong contemporary knowledge, and the ability to work independently and on multidisciplinary teams. The successful candidate will also have demonstrated the ability to deliver what is needed on-time, holding self and team accountable for commitments, decisions, actions and behaviors. Excellent oral and written communication skills, with the ability to effectively articulate understanding of process science, in order to drive decision making, impact assessments, design of studies, etc., in a multi-disciplinary team environment.
Responsibilities
· Support the design, construction and qualification of upstream & downstream equipment on site through to technology transfer and commercialization.
· Support establishment of the commercial process and routine manufacturing
· Supporting experimental design, execution, data analysis and interpretation.
· Interpreting trends observed in commercial process monitoring (e.g., proactive process analysis (PPA), continued process verification (CPV), statistical process control (SPC) multivariate analyses (MVDA)), and for further technical investigations and process changes that seek to drive improvements to yield and/or robustness.
· Supporting deviation management.
· Supporting change control prioritization and implementation.
· Authoring and reviewing of batch documentation, technical reports and global regulatory submissions.
· Supporting multidisciplinary teams (manufacturing science and technology, quality, analytics, regulatory) for process improvement and troubleshooting with end-to-end product focus.
· Applying LeanSixSigma tools by: Securing continuity of an appropriate LSS/CEM level of knowledge. Facilitating problem solving & risk assessment (FMEA) projects/meetings. Making problems visible and strive for continuous improvement.
· Serving as a key member during internal audits and external inspections/audits
· Lead and support various manufacturing science and technology organizational initiatives as needed (examples include safety, financial forecasting, work standardization, etc).
· Maintain continuous focus on quality and safety compliance and unflinching focus on the customer.
· This role may require shift work support after the facility startup phase is complete.
Experience & Skills
· Experience with upstream cell culture and/or downstream purification of biological molecules.
· Experience with technology transfer, regulatory filing, and commercial drug substance manufacturing of biologics is a plus.
· Technical operations experience in the drug substance manufacture of biological molecules at commercial scale.
· Prior experience in drug substance process development, process characterisation studies, process performance qualification and validation, site readiness, batch record reviews, authoring regulatory CTD sections and/or working with external contract organisation for development and/or manufacturing.
· Working knowledge of statistical methods for DOE design and data analysis (e.g., JMP or Design Expert software)
· Working knowledge of statistical process control (SPC), multivariate analysis (MVDA), and/or process analytical technologies (PAT) techniques for biologics processes
To apply contact Martin Lynch on 087-344 3581.
Email CVs to