דרושים Senior Automation Engineer Manufacturing ב-Msd ב-אירלנד

Job Description

Bring energy, knowledge, innovation to carry out the following:

• Support and execute experimental design, data analysis and interpretation to resolve complex cell culture and / or downstream deviations.
• Support the process sciences team during small scale model run execution, including media & buffer preparation make up, equipment set up, run execution, sampling and data analysis.
• Author and review standard operating procedures, study protocols and reports as required.
• Support global regulatory submissions as needed.
• Support multidisciplinary teams (MS&T, quality, analytics, regulatory) for process improvement and troubleshooting.
• Assure effective application of Lean Six Sigma and Change Management tools in the Analytical Sciences group by:
• Secure continuity of an appropriate level of knowledge.
• Facilitate problem solving & risk assessment (FMEA) projects/meeting.
• Make problems visible and striving for continuous improvement.
• Support alignment and knowledge exchange with development organizations, other commercial nodes and external manufacturing partners.

What skills you will need:

In order to excel in this role, you will more than likely have:

• Bachelor’s degree (or higher) in in Biological Sciences/Chemistry /Chemical Engineering/Biological Engineering.
• 5 years directly related experience in academia, pharmaceutical or biotechnology company.
• 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.
• Experience in executing experimental programs in the laboratory.
• Working knowledge of statistical methods for DOE design and data analysis (e.g., JMP or Design Expert software).
• Experience with technology transfer, regulatory filing, and commercial drug substance manufacturing of vaccines is a plus.
• Knowledge of and experience in applying Six Sigma and Lean methodologies
• Desirable evidence of Continuous Professional Development.

Please don't hesitate to contact the Talent Acquisition Advisor assigned to this role should you need any support during our recruitment process.

Please feel free to speak to us about what flexibility means to you during your application.

So, if you are ready to:

Invent solutions to meet unmet healthcare needs,please apply today.

Current Contingent Workers apply

*A job posting is effective until 11:59:59PM on the dayBEFOREthe listed job posting end date. Please ensure you apply to a job posting no later than the dayBEFOREthe job posting end date.

Job Description

Bring energy, knowledge, innovation and leadership to carry out the following:

• Provide technical support to the project and site automation teams.
• Maintain DeltaV DCS automation systems in a validated state.
• Design, develop, and maintain automation applications and infrastructure.
• Ensure that objectives are met in compliance with company requirements, safety standards, and reliable supply to customers.
• Provide regular updates on delivery, cost, and resourcing to the automation lead.
• Ensure that technical solutions adhere to corporate and compliance standards.
• Seamlessly transition new or modified automation systems from capital projects to ongoing operations.
• Lead continuous improvement efforts.
• Ensure the success of production support processes for DCS automation systems.
• Collaborate with the business on the effective use of automation solutions.

What skills you will need

• Bachelor's degree or higher in Automation Process Control, Computer Science, or Software Engineering (other engineering degrees considered based on experience).
• Extensive technical and operational expertise on DeltaV DCS systems.
• Extensive technical and operational expertise in data historian and reporting systems, computer system validation, and control system/shop floor integration.
• Understanding and application of S88 batch.
• Experience with facility commissioning and startup.
• Leadership in implementing and supporting automation solutions.
• Experience working in a GMP environment and with regulatory inspections.
• Strong project execution skills along with routine/support work planning and scheduling.
• Experience in mentoring and coaching junior engineers.
• Proficiency in reviewing and approving technical and compliance documentation.
• Vendor management skills.
• Knowledge of Lean Six Sigma methodology with demonstrable problem-solving skills would be beneficial
• Excellent communication, presentation, and interpersonal skills.
• Strong knowledge of pharmaceutical and manufacturing processes would be beneficial.

So, if you are ready to:

Current Contingent Workers apply

*A job posting is effective until 11:59:59PM on the dayBEFOREthe listed job posting end date. Please ensure you apply to a job posting no later than the dayBEFOREthe job posting end date.

Job Description

What you will do:

Bring energy, knowledge, innovation and leadership to carry out the following:

• Lead engineer on new product introductions and/or technical transfers to and from the site, including new technologies.
• Co-develop new SM API products with Research and Development partners globally.
• Direct day-to-day project development plans.
• Provide knowledge and subject matter expertise on API processing unit operations and scale up to colleagues in Quality, Supply Chain and Manufacturing Operations.
• Evaluation of raw materials, development of process fits, safety and environmental reviews, batch sheet reviews, regulatory and validation compliance, process monitoring and cycle-time studies, deviation investigations and resolution, and development of filing strategies.
• Work as part of a multi-functional, diverse team to deliver results within schedule and product launch milestones

What skills you will need:

In order to excel in this role, you will more than likely have:

• A qualification in Chemical Engineering or related discipline. An advanced degree (MS, PhD) in Scientific or Engineering related field is desirable.
• A minimum of 6 years post-graduation experience in a pharmaceutical manufacturing organisation or process development role with experience of new product introduction, technology transfer and process fit.
• Experienced in leading cross-functional teams.
• Demonstrated ability to work as part of diverse teams in an all-encompassing manner.

So, if you are ready to:

Current Contingent Workers apply

*A job posting is effective until 11:59:59PM on the dayBEFOREthe listed job posting end date. Please ensure you apply to a job posting no later than the dayBEFOREthe job posting end date.

Job Description

Current Contingent Workers apply

Language(s) Job Description:

*A job posting is effective until 11:59:59PM on the dayBEFOREthe listed job posting end date. Please ensure you apply to a job posting no later than the dayBEFOREthe job posting end date.

Job Description

Key Accountabilities:

Ensure that personal safety and the safety of team members is prioritized at all times. Ensures that all permits, LOTO, SPA, and required EH&S training are in place or completed prior to performing any CQV activities.
 Coordinate with the Engineering Leads and QAV Leads to establish Test Plans that capture strategy for CQV testing, test scripts and acceptance criteria
 Work with the Project Automation team, determine and coordinate automation testing that will be required as part of the equipment/system(s) assigned in the CQV Lead scope.
 Actively manage the execution of all CQV testing with a very low deviation level.
 For CQV testing that is planned during the FAT phase and leveraged as defined in the Project Validation Master Plan (PVMP)
 Partner with the Engineering Lead to plan for the testing and ensure that the vendor and vendor documents are ready for CQV level testing. Produce Monthly Reports for the CQV Phase, in line with overall project reporting requirements.
 Attend & contribute to CQV and project meetings as required to communicate status, share learning, and participate in planning discussions.
 For systems requiring cycle development (CD) and performance qualification (PQ), generate document, execute studies, gather data and generate final CD and PQ reports.
 Maintain the site Equipment Validation Master Plan
 May be required to perform other duties as assigned.

Educational and Experience Requirements:

A minimum of a Level 8 Bachelor’s Degree in Engineering, Science or an equivalent technical discipline.
 A minimum of 8 years of relevant experience in the biotechnology and/or pharmaceutical industry or commensurate experience.
 At least 2 years experience in the planning, document generation, support or execution of CQV activities in a biologic drug substance manufacturing plant.
 Experience with CQV execution in a greenfield plant is highly desirable.
 Knowledge of engineering principles as applied in a biotechnology and/or pharmaceutical manufacturing environment is required.
 Thorough understanding of good engineering practices (GEP) and good manufacturing practices (GMP) is required.
 Experience developing and executing IQ (Installation Qualification), OQ (Operational Qualification and PQ (Performance Qualification) Protocols.
 Knowledge of cycle development (CD) and performance qualification (PQ) practices is highly desirable.
 Excellent communication skills (written and oral).
 Ability to multi-task and handle tasks with competing priorities effectively.
 Strong technical aptitude (i.e. able to read and comprehend technical documentation and execute procedures).
 Proven ability around working cross functionally, focusing on meeting and tracking to schedules and embracing an interdependent work culture.
 Ability to manage multiple priorities and know when to escalate issues for resolution.
 Proficiency in Microsoft Office and job-related computer applications required.
 Experience with paperless validation systems is an advantage.

Other Job Requirements:
 This role is a site based role.

Current Contingent Workers apply

*A job posting is effective until 11:59:59PM on the dayBEFOREthe listed job posting end date. Please ensure you apply to a job posting no later than the dayBEFOREthe job posting end date.