Job Type: contract

Senior Project Manager

Ascend PM are hiring a Senior Project Manager 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 Senior Project Manager will lead project teams and interact across functional and site department groups to achieve project objectives. These capital projects could include new builds, facilities/utilities system and/or equipment lifecycle replacements, upgrades, manufacturing improvements and changes to support New Product Introductions. The candidate will lead all aspects of their project(s): Safety, planning, cost, schedule, risk, communications, resources, team dynamics and performance, implementation, monitoring, completion and follow-up.

Key Responsibilities:

• Project management and delivery of projects including project planning/scoping and execution, prioritization, resources management, status management and external communication through the Engineering Project Delivery Process.
• Working with various stakeholders, to scope projects and ensure requirements are satisfied. Managing expectations and communicating project progress and challenges to these stakeholders.
• Develop and/or review engineering technical specifications and bid documents for engineered equipment, materials engineering, and construction service contracts
• Lead day to day design (where applicable) and construction management of project works, including procurement, installation, and commissioning
• Provide engineering support for manufacturing processes and equipment within the manufacturing facility by designing, specifying, purchasing and constructing mechanical systems and components (with the aid of an A&E firm where required).
• Implement and maintain quality control processes to ensure that installations and deliverables meet industry standards and client expectations.
• Strategic solution seeking to complex project phasing and execution issues. The Project Manager will be responsible for their portfolio of projects from concept, through design, construction, commissioning and operation
• Coordinating the introduction of new equipment including driving the project team problem solving and troubleshooting process prior to qualification & start-up
• Leader of multidisciplinary site teams
• Work in a collaborative manner within the Process Teams structure and contributes to Root Cause Investigations and Cross Functional Investigations.
• Role model safety leadership. Support a safe working environment by driving compliance with environmental health/safety practice, rules and regulations. Ensure projects are designed with superior levels of environmental control, health and safety built in.
• Supervise contingent workers as needed. These workers include construction managers and all general craft labour and A&E firm personnel
• Support team members in the management of third party contractors and outsourced partners to ensure the optimal delivery of portfolio against safety, cost, quality and schedule objectives
• Works with Project Controls to manage and report on the Capital Budget for the assigned project.
• Present projects to senior leadership at governing bodies for updates and approvals
• Limited travel may be required to support execution of projects

Experience and Qualification:

• Bachelor’s Degree in Engineering or Relevant Experience
• Typically, 5+ years project management/engineering experience, preferably in the biotechnology industry / aseptic pharmaceutical environment
• Proven project management experience from project inception through to handover
• Strong technical capability with hands on experience in a technical role within a high-volume manufacturing environment, is advantageous
• Demonstrated experience in a GDP Compliant environment.
• 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
• Data driven decision maker
• Ability to work to tight deadlines in a fast-moving environment

Senior Engineer

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

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 / 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

CQV Engineer

Ascend PM are hiring a CQV 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:

Clean Utilities Commissioning and Qualification (C&Q) engineer for various capital projects. Ensure the C&Q activities associated with various capital projects are completed safely, as per schedule and in compliance with GMP and Quality Requirements.

Key Responsibilities:

• Commissioning & Qualification of Clean Utility Systems and execution of qualification documentation
• Generation of all C&Q test documents (C&Q Plan/Set to Works/FAT/SAT/IV/FT/C&Q Summary Report)
• Provide technical assistance during investigations and system design.
• Coordinates and Supervises all C&Q activities on their systems.
• Ensures the C&Q schedule is maintained.
• Manages Daily C&Q coordination meetings.
• Responsible for Tracking and Reporting of C&Q status and risks/issues.
• Ensures Startup of equipment/utilities is completed in a safe and coordinated manner.
• Assist in the development of User Requirement Specifications (URS’s) and Quality Risk Assessment for Equipment and Automated Systems (QRAES).

Qualifications & Experience:

• 3+ years experience in Engineering or Commissioning and Qualification Management
• Technical qualification at third level or equivalent in Engineering.
• Extensive knowledge and demonstrated experience managing Commissioning and Qualification for Pharmaceutical / Biotechnology projects preferred
• Knowledge of safety, GMP and environmental regulatory requirements.
• Demonstrated strong Communication and Leadership skills
• Demonstrated ability to collaborate with senior stakeholders to achieve optimal outcomes.
• Strong understanding of a risk‐based approach to commissioning and qualification within the biotechnology industry
• Familiarity with paperless validation systems.

Technical Writer

Ascend PM are hiring a Technical Writer 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 has opened within the Manufacturing Support team for a Technical Writer. In this role, you will be responsible for owning and managing change controls critical to site development and managing the operational documentation updates as required by each project.

 

Key Responsibilities:

 

  • Develop/ Update and maintain Operations procedures in accordance with site and corporate requirements. Serve as a document owner. Assist in generation of training materials and may assist in providing training on scientific or technical aspects of the process.
  • Liaise with Manufacturing/Inspection/Engineering regarding documentation changes in an effective and timely manner
  • Develop protocols for execution in Manufacturing & Inspection in support of change controls, non-conformances & troubleshooting investigations with support from relevant SMEs
  • Involvement in projects as part of continuous process improvement and / or troubleshooting
  • Ownership and management of change controls as required
  • Issuance and updates of paper batch records in line with production schedule
  • Liaise with Quality Assurance to ensure that GMP standards are maintained in line with current OS
  • Partner with Operations lead/appropriate SME to ensure updates are correct and aligned with project deliverables/ timelines.
  • Perform document trending upon project completion to identify keys issues/mistakes in document processing.
  • Support data verification of Operations owned protocols reports and risk assessments
  • Support the production support team in reducing document turnaround times
  • Use specified software packages and standard procedures, responsible for compiling and maintaining all relevant documentation including SOPs
  • Provide technical and clerical support to the manufacturing, inspection & engineering teams in the preparation of documentation, collation of data and tracking of SOPs
  • Ensure Non-conformance are triage within the established goal and serve as a deviation owner for minor deviations.
  • Own corrective /preventative actions and effectiveness verification.
  • Support execution of C&Q, characterisation, functional testing protocols as required by project. NOTE: This may require flexible working hours.

 

 

Experience & Qualifications:

 

  • Bachelor’s degree in a Science or Engineering discipline.
  • 3+ years of experience in Chemistry/Microbiology/Engineering/Validation gained within a biotech, pharma or health care organization
  • Experience with regulatory compliance in cGMP manufacturing and testing of pharmaceutical products an advantage

 

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