Fill Finish Specialists / Process Design Engineers

Recruiter
PM Group
Location
Carlow / Cork
Salary
Not disclosed
Posted
17 Sep 2018

PM Group are currently seeking to expand our technical teams with the addition of expertise experienced in Fill Finish, Syringe, Vial, Process projects to support a growing portfolio of Secondary Pharma projects based in our Cork office & onsite in Carlow.

PM Group is an international project delivery company operating across Europe, the USA and Asia. We have a 45 year track record in project management, process design, facility design and construction management for leading multinational companies.  We are world leaders in the pharmaceutical, food, mission critical, medtech, advanced manufacturing and energy sectors.

PM Group are currently seeking to expand our technical teams with the addition of expertise experienced in Fill Finish, Syringe, Vial, Process projects to support a growing portfolio of Secondary Pharma projects based in our Cork office & onsite in Carlow.

The broad base of work across the PM Group offers the opportunity to work on a range of projects, from conceptual stage through to detailed design, commissioning and qualification. Some projects will require travel and may involve overseas placements of varying durations.

The proposed role will include but will not be limited to the following:

  • Leading Process engineering activities within a sterile fill-finish environment
  • Coordination of Process Mechanical Design Team to achieve project design deliverables
  • Technical input and support for Equipment / Mechanical Design Team
  • Coordination of process and equipment design with other design disciplines and equipment suppliers
  • Ownership of equipment modules and packages through design and procurement phases
  • Completion of Design Risk Assessments
  • Participation in Technical and Safety reviews
  • Interfacing with client design team/end users
  • Mechanical optimization/site support
  • Delivery of agreed design scope within budget hours and schedule
  • Prepare Scope of Work Documentation for equipment packages and site based activities including commissioning and systems qualification
  • Prepare Mechanical Project Specifications

Requirements: Technical experience of key interest for the role(s) include:

  • Degree in Mechanical or Chemical/Process Engineering, relevant process experience may also be considered
  • 5+ years’ experience within Biotech/pharmaceutical Manufacturing environments with a specific background in Biologics sterile/aseptic fill finish
  • Deep Knowledge of sterilization principles and practices
  • Experience in Sterile operations including: Batch Formulation, Filling, Freeze-drying, Sterilization, Automatic and semi-automatic inspection, Parts preparation, Clean rooms and clean facility operation, Sterile Isolators and RABS, Filtration, Contamination control and cleaning processes, Clean services, Packaging systems, Single-use technologies
  • Solid experience of project lifecycle activities to include the qualification of equipment in conjunction with Project engineering teams
  • Demonstrable experience in drafting, executing and reporting of documentation i.e. IQ, OQ, PQ protocols
  • Self-starter, experience in leading a design team and in coordinating the efforts of others
  • Good communication skills (ability to lead Technical and Safety reviews)
  • Chartered status desirable but not necessary