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 role 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 Technical Lead 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 Technical Lead is to support the design and implementation of new Syringe Inspection Lines. The successful candidate may be requested to support Filling, Warehouse / Cold-Storage and Parts Prep areas as required.
The Engineering Technical Authority (ETA) within Corporate Engineering leads the design for critical projects as well as provides technical expertise and direction across global operations network. This position is part of the ETA organization that includes Process Systems, Facilities and Utilities, Site Project Engineering, and other engineering technical functions. The Technical Lead will report to the Process Technical Lead for the project, who is also a member of the ETA.
The successful Technical Lead will have extensive experience in Automatic Inspection Equipment, Syringe Filling, Material Logistics and Drug Product Storage Area design, development, and implementation.
The successful candidate must be willing to relocate to the project site for the duration of the projects. The position requires the ability to travel internationally as needed to deliver the project including overnight stays.
Experience & Qualifications:
- Bachelor’s degree and over ten (10) years of experience in Engineering or a related technical discipline AND Experience leading teams, projects, and programs
- Extensive experience with Automatic Syringe Inspection Equipment design and delivery.
- Extensive experience in the delivery of capital projects as part of the design or process team.
- Proven ability to provide direction and oversight to equipment vendors to deliver for the capital project
- Experience in providing technical support to manufacturing facilities.
- Proven experience and track record of compliance in a highly regulated environment
- Demonstrated ability to effectively lead and partner in a complex, matrixed organizations
- Demonstrated experience in selection of and implementation of design elements for improved sustainability.
- Extensive experience in system Design, Install, Turnover and CQV.
- Extensive experience in generation of Design Qualification documentation in addition to reviewing/approving both design and CQV related documentation.
- Proven ability to work as part of cross functional team to deliver project requirements.
- Strong analytical skills to identify potential improvement opportunities
- Knowledge of industry trends (e.g., regulatory and compliance, technology, human performance programs, sustainability, asset insurance, etc.) to stay at the forefront of technology implementation
- Knowledge of applicable regulations (e.g. cGMP, building codes, fire codes, electrical codes, OSHA, LEED, Energy codes, Mechanical codes, Boiler and Pressure Vessel codes) to ensure compliance. Represent with outside firms, technical societies and regulatory bodies.
- Ability to develop, implement and utilize tools to drive efficiency in meeting business needs; establish measure and evaluate performance metrics, taking actions based on results.
Ascend PM are hiring a Senior 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 Clean Utilities Project Engineer will have previous relevant experience of Pretreatment Systems, Clean Steam, WFI and Process Air generation and distribution systems, to provide client side design input at the Basis of Design, Detailed Design, Commissioning, Qualification and handover stages of a design project for a Fill/Finish Building.
The scope of the role also includes design input and support during the project phases for various ancillary areas such as the existing Warehouse, a new -30Deg Coldroom, Laboratory reconfigurations, general site infrastructure and the new Multistorey Carpark. Due to the nature of the role, the Clean Utilities Engineer will also be required to support FAT’s at vendor sites at times during the project.
Key Responsibilities:
- To provide technical expertise working with other project stakeholders, in order to achieve design deliverables
- To track, manage and communicate adherence to discipline project milestones
- To coordinate client side clean utilities (Clean Steam / WFI / CA) design by liaising with Site SME’s and Engineering Technical Authority (ETA).
- To lead the client side design reviews in the area of Clean Utilities
- To participate in cross functional package, area, or overall design teams as required in support of overall design goals and expectations
- To input into the Vendor selection and Technical Assessment in support of the instrumentation framework, and/or procurement agreements.
- To participate in design reviews, model reviews, etc., and to input on technical elements of the design
- To execute Drawing, URS, HDS, SDS, Equipment & Instrument Specifications and other reviews associated with Clean Utility installations.
- To participate in CMSAT’s / Loop checking, including any trouble shooting activities
- To provide input and assistance to Automation, C&Q and Validation in terms of equipment packages as required.
- To participate in the design reviews and specifications review of any Vendor Package Equipment in the Facility.
- Provide attendance / assistance for FAT’s / SAT / C&Q and Validation activities at various locations, site or Vendor, as required
- To provide input into the calibration program for clean utilities. To coordinate with site Metrology Group to ascertain calibration requirements and to ensure the execution of calibrations, both equipment and field instruments, in line with these requirements.
- To liaise with the site Maintenance Group and to ensure that any data gathering required to support the MAXIMO system requirements.
- To provide input / direction into schedule and cost discussions, as required, in order to meet the project objectives as defined by the Design Manager, Project Manager and Steering Committee, or designees.
- A site presence will be required during construction. This will involve oversight / supervision of the Clean Utilities element of the project.
Experience & Qualifications
- Minimum of 10 years of experience in pharmaceutical design / build / commission / start-up with direct responsibility for Engineering Documentation, Project Execution or Facility Design.
- Degree level qualification in Chemical / Mechanical Engineering, or similar/equivalent.
- Direct experience in a similar scale project.
- Ability to challenge, defend and present technical aspects of design and commissioning.
Ascend PM are hiring a Document Control Associate 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 Document (EDMS) Controller will have previous relevant large scale project experience to support the client team side design during the Basis of Design, Detailed Design, Construction, Commissioning, Qualification and handover stages of a design project for a Fill/Finish Building.
The scope of the role also includes liaising with the Architectural & Engineering Company and any third-party consultants involved in the project to coordinate the overall document receipt, review and handover process and management of the project EDMS. The most likely platform is ACC.
The EDMS will span design through design, construction, commissioning, qualification and handover.
Key Responsibilities:
- To support client side Documentation Control activities.
- Liaise with ETA system owner to ensure EDMS compliance with corporate requirements
- Liaise and coordinate with A&E Document Control to streamline document management system
- Management of Owner EDMS workflows and tracking of incoming / outgoing documentation.
- Reporting and communicating EDMS status and adherence to milestone documentation deliverables
- Ensure documentation being logged onto the EDMS is correctly formatted and version controlled prior to distribution via EDMS
- Ownership / Maintenance of Project Document Distribution Matrix and alignment of same to EDMS workflows
- Ensure that documents are distributed to correct recipients as per DDM and document workflows
- To determine, in conjunction with ETA, the end-state requirements for handover of project related files via the EDMS and to ensure that these are agreed / incorporated into the EDMS architecture for the project.
- To provide input / technical direction into the configuration / operation of the EDMS
- Provide user training on EDMS usage and document control procedures
- Maintain confidentiality and integrity of EDMS
- This is a key role in the project and a site presence will be required during all phases of the project.
Experience & Qualifications
- Diploma in Business Administration, Engineering or related relevant experience in large scale capital projects
- Minimum of 10 years of experience in large scale capital projects document control.
- Experience in automated EDMS such as PIMS, Fusion, Procore, ACC etc.
- Ability to communicate documentation requirements across multiple disciplines and end-users.
Ascend PM are hiring a Construction Safety 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
We are looking for a qualified and experienced construction safety engineer to join our clients team and ensure that construction projects comply with the highest standards of health and safety.
You will report to the project manager and liaise with the relevant stakeholders, including EHS POC.
Responsibilities
- Foster a strong safety culture and adherence to best in class standards through the following:
- Walk construction work with the contractor in advance of execution to ensure safe practices are followed
- Execute gap analysis studies, ranging from regulatory requirements, GDE/SOPs and overall EHS cover. Report the outcome to the Project Manager for next steps consideration
- Input to safety stand downs & one-point lessons (typically executed by GC or contractor EHS reps)
- Preview RAMS, lift plans and temporary work designs to ensure best practices are followed
- Monitor and update safety signage
- Conduct site inspections and risk assessments to identify and eliminate any hazards or violations
- Keep the relevant safety reporting data up to date.
- Plan and execute EHS demonstrations, workshops, training etc with our CM team.
- Work closely with our PSCS and PSDP in relation to the execution of all works on site
- Report any accidents, incidents, or near misses. Input into the investigations, as appropriate
- Coordinate and cooperate with the project manager, the site supervisor, the client, and the relevant authorities and stakeholders on safety matters
- Keep abreast of the latest developments and best practices in the field of construction safety
- Advise the project team/construction management of potential Safety efficiencies/improvements
- Provide safety moment topics and content for the project team.
- Populate relevant EHS content on displays/notice boards within ADL1X portacabin and Construction zones.
- Request clarity on any Amgen EHS training/documentation/requirements/SOPs for the relevant Amgen EHS POC.
Requirements
- Bachelor’s degree in engineering, occupational health and safety, or a related field.
- At least three years of experience as a construction safety engineer or a similar role, ideally at a biopharmaceutical facility (or similar).
- Knowledge of the construction industry and the relevant safety regulations and standards.
- Excellent communication, interpersonal, and leadership skills.
- Ability to work independently and as part of a team.
- Attention to detail and problem-solving skills.
Ascend PM are hiring a Senior Validation 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:
An exciting opportunity for a Senior Validation Engineer. In this role, you will be responsible for delivering on the qualification and validation program, which will include planning and execution of validation/requalification activities on critical equipment.
This role will focus on HVAC qualification & validation in the production environments, including managing the routine re-qualification program of airflow visualisation, filter integrity, velocity & particle monitoring testing activities as well as testing in response to changes & expansion of the production environment. This role may support (re)qualification of additional equipment on site as required (E.g. Isolators, E-Beams etc.)
The Validation department performs equipment, utility, facility, cleaning, and sterilization validation activities to ensure compliance with company procedures and industry standards in support of Operations and Quality Systems for Drug Product Manufacturing.
Key Responsibilities:
- Provide technical validation support to meet site objectives, comprising the full validation lifecycle process.
- Develop, review, and approve validation plans, protocols, and discrepancy summary reports.
- Lead the execution of airflow visualization, filter integrity, velocity, and particle monitoring testing activities.
- Lead the execution of cycle development, performance qualifications, and requalification programs for VPHP isolators
- Collate and report relevant validation data and metrics.
- Assist in the development and improvement of the validation lifecycle process while ensuring compliance with all applicable regulations and standards.
- Provide validation support for quality management system, including change control, deviation, and CAPA processes.
- Coordinate projects and prioritize workload in line with site priorities.
- Participate in multidisciplinary site and multisite teams, such as cross-functional investigation teams and change control.
- Update and maintain validation Standard Operating Procedures (SOPs) in accordance with site and corporate requirements.
- Comply with the responsibilities outlined in the Site Safety Statement and champion safe working practices.
Experience & Qualifications:
- Bachelor of Science/Engineering degree or equivalent.
- Knowledge of cGMPs and other worldwide regulatory requirements.
- Experience qualifying HVAC systems and/or executing VPHP qualifications.
- Familiarity with Quality and Document Management Systems, including Trackwise Deviations, CAPA and Change Controls, Maximo, CDOCs, Kneat.
