Job Category: Project Engineer

Ascend PM are hiring a Project Engineer to join our clients team, a multinational biopharmaceutical company based in Dublin. This is a great Contract opportunity to join a growing team. Initially 12 Month Contract with view to extend. Contact or email CV to clairebrogan@ascendpm.ie to find out more.

Overview:

The Project Engineer is responsible for assisting with the Engineering elements of the expansion project through design, implementation, and operational readiness in collaboration with multiple stakeholder groups.

Key Responsibilities:

• As a member of the Engineering team, support the expansion of the existing manufacturing facility, focusing on filling, inspection, and formulation equipment.
• Support the manufacturing readiness strategy, startup, and validation of new systems and equipment to ensure requirements are in line with standards and fit for purpose.
• Assist with equipment project deliverables of setup, calibration, spare parts management, functional testing, and start-up support.
• Ensure consistency in equipment design and practices, with a focus on simplifying processes and tasks.
• Collaborate with diverse groups including Manufacturing, Quality, PD, Automation, IS, EHSS, and Global Engineering to ensure project delivery.
• Establish maintenance strategies and develop initial PM programs for process equipment.
• Travel as required to support project execution.

Qualifications & Experience:

• Minimum of a Bachelor’s Degree in Engineering (Mechanical, Electrical, or Chemical) with typically 4+ years of experience in engineering projects and systems.
• Fundamental knowledge of applicable quality management and regulatory requirements.
• Solid leadership, technical writing, and communication/presentation skills.
• Experience in change control, non-conformance, corrective and preventative actions, and validation practices.
• Experience in developing strategies for new product introduction and new technology deployment.
• Team player who actively promotes a culture of clear communication, collaboration, and engagement at all relevant levels for effective decision-making.
• Manufacturing experience in a biopharmaceutical formulation/fill/finish facility.
• Strong technical ability to understand and resolve complex problems as part of a focused and high-performing team.
• Experience in vendor management and contract negotiations with a focus on equipment suppliers.
• Independent, self-motivated, organized, and able to multi-task in project environments.

Ascend PM are hiring a Senior Engineer to join our clients team, a multinational biopharmaceutical company based in Dublin. This is a great Contract opportunity to join a growing team. Initially 12 Month Contract with view to extend. Contact or email CV to clairebrogan@ascendpm.ie to find out more.

Overview:

This opportunity is part of the global Process Development organization. This role will require the candidate to support manufacturing at various aseptic drug product contract manufacturing sites around Europe. Assignments may include support for new product introductions, lifecycle changes and ongoing commercial production. Depending on assignments, the candidate may support a broad range of product formats (cartridges, syringes, freeze dried and liquid vials) and a broad range of product types (including monoclonal antibodies, therapeutic proteins, small molecules and more novel modalities), across multiple manufacturing sites.

Key Responsibilities:

• Develop as a drug product technical expert, to provide leadership and solutions troubleshooting parenteral drug product manufacturing, for all processing stages from drug substance thawing, formulation, filling, lyophilisation, inspection, and transportation of vials, syringes and devices for parenteral products through the new product introduction (NPI) or commercial phases.
• Work with contract manufacturing partner SME’s, Global Operations, Contract Manufacturing Quality and drug product process teams.
• Work as a member of cross site teams to support contract manufacturers and to identify and resolve potential issues
• Provide process development expertise for commercial drug product processing in specific areas such as aseptic processing, process characterisation, technology transfer, and process validation.
• Troubleshoot issues with drug product processing technologies and equipment.
• Identify and implement operational improvements for current and new sterile operations.
• Support commercial drug product manufacturing operations and contract manufacturing quality with technical evaluation of NC/CAPA.
• Visit contract manufacturing sites to observe production operations and build relationships
• International travel will be required to visit contract manufacturing partner sites in Europe.

Experience & Qualifications:

• 3 -5 years’ pharmaceutical manufacturing experience in either a drug product or drug substance manufacturing environment
• Knowledge of cGMP’s
• Third level bachelor’s degree in Science, Engineering or a relevant quality discipline
• Language skills such as Italian or German.
• Experience with aseptic drug product processes such as; component preparation (siliconization, autoclaving, depyrogenation), sterile filtration, filter integrity testing, filling, freeze drying, capping, manual and automated visual inspection
• Experience with different aseptic drug product presentations such as pre-filled syringes, cartridges, lyophilised vials and liquid vials
• Experience with the quality testing methods and interpretation of results for biological molecules
• Aseptic drug product validation experience such as; media fill, sterilisation validation, equipment qualification, process validation
• Experience dealing with contract manufacturing organisations
• Project management experience

Ascend PM are hiring a Project Engineer to join our clients team, a multinational biopharmaceutical company based in Dublin. This is a great Contract opportunity to join a growing team. Initially 12 Month Contract with view to extend. Contact or email CV to clairebrogan@ascendpm.ie to find out more.

Overview:

The Project / Equipment Engineer reports to the Senior Manager for Strategic Engineering Projects and is responsible for scoping and executing technical projects supporting Drug Product manufacturing within Formulation, Component Preparation, Vial/Syringe Filling, Lyophilisation, Device Assembly, Inspection, Filter/Filter Integrity Testing areas. This includes qualification of new equipment and implementation of associated reliability and maintenance programs.

Key Responsibilities

• Project management and execution of assigned projects including project prioritization, resources management, status management and external communication.
• Working with various stakeholders, to scope projects and ensure requirements are satisfied. Project input will span from concept, through design, construction, commissioning and operation
• Coordinating the introduction of new processes, equipment and materials including problem solving and troubleshooting equipment issues prior to qualification & start-up
• Development and implementation of maintenance programs and spare parts inventory optimization with the introduction of new equipment.
• Ability to translate strategic/emerging technology solutions into pragmatic executable plans
• Development and management of change controls
• Participate as a member of multidisciplinary site and multisite teams
• Development of detailed specifications, engineering documents, protocols and standard operating procedures
• Work in a collaborative manner within the Process Teams structure and contributes to Root Cause Investigations and Cross Functional Investigations.
• Works in a collaborative manner with the System Owners, Maintenance Supervisors & Technicians, Capital Project Engineers and Vendors to perform equipment upgrade and/or retrofits.
• Perform all tasks with due care and attention ensuring compliance with Good Manufacturing Practices and company requirements, policies and procedures
• Support a safe working environment by complying with environmental health/safety practice, rules and regulations
• Travel may be required to support execution of projects

Experience and Qualification:

• Bachelor’s Degree in Engineering (Mechanical, Electrical or Chemical) or Relevant Experience
• Typically, 3+ years engineering experience, preferably in the biotechnology industry / aseptic pharmaceutical environment or Automated Inspection and/or Automated Device Assembly
• Proven project management experience.
• Strong mechanical capability with hands on experience in a technical role within a high-volume manufacturing environment, is advantageous
• Demonstrated experience in a GDP Compliant environment.
• Experience in MS Office, MS Project, Change Control & Document Management Systems
• Proven ability working cross functionally, delivering technical solutions and implementing improvements.
• Solid leadership skillset and experience working in a team environment, embracing an interdependent working culture that delivers results
• Technical report writing and communication/presentation skills