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Associate Director- Packaging Engineering: Cork

Core Purpose

In this role you will be accountable for both personnel and task management and may be responsible for managing people managers.

Core Job Responsibilities :

  • Determine the functions most critical to departmental success and proactively engage these to drive business forward.
  • Lead multiple components of departmental strategic initiatives.
  • Provide technical guidance and training to junior group members.
  • Examine and work to resolve inter-departmental working issues from a broader organisational perspective.
  • Analyse, revise and develop internal procedures and systems required to ensure GMP compliance.
  • Manage complex processes across functions and interact effectively with the other team members to ensure product meets regulatory, performance, and cost requirements.
  • Lead technical investigations and assessment of deviations.
  • Advise more junior staff or members of project teams in the initiation and execution of new methods, considering economic, regulatory and safety factors
  • Present results of work, interpret data, and draw conclusions regarding presented material and nature of work.
  • Manage the planning and implementation of new site start-ups.
  • Make recommendations for cost reduction initiatives as related to materials, labour or overhead.
  • Make recommendations for continuous improvement in all operation processes.
  • Investigate the feasibility of applying advanced principles and techniques of related engineering specialty to products and problems.
  • Demonstrate ability to recognise anomalous and inconsistent results and interpret experimental outcomes.
  • Manage external vendor relationships and negotiate contracts.
  • Manage budget for pharmaceutical/packaging engineering-related projects and activities.
  • Lead the day-to-day activities of a team of personnel, which may include people managers.
  • Manage team of personnel, including hiring, organising and/or conducting training, conducting performance reviews, and ensuring assigned work is performed to required standards.
  • Work independently on significant portions of projects.
  • Make contributions to specialist literature and conferences through publication and presentation of technical advances.
  • Manage activities at third party sites, including providing project timelines, resolving issues, on-site troubleshooting, and providing overall technical support; may negotiate pricing for defined projects.
  • Coordinate the specification, installation, utilisation, qualification, and improvement of equipment used for solid dose and liquid products.
  • Approve documents for Regulatory filings, and review filings, including sections from other disciplines.
  • Identify Bill of Material components for company products.
  • Project involvement: serve as a lead for large scale cross-functional projects with the ability to identify and adjust for potential issues

Interested applicants should be able to:

  • Ability to identify risks in the business, elevate the issues and propose and defend solutions to functional leadership.
  • Represents the company as a SME across multiple areas.
  • Demonstrate problem solving skills and negotiate with external, partners, production sites and vendors.
  • Participate in business negotiations in support of new projects.
  • Provide expertise and guidance in interpreting and implementing governmental regulations, agency guidelines, and internal policies to ensure compliance at production sites.
  • Represents the company as an SME in regulatory inspections and quality audits, both internal and external.
  • Communication and adherence to timelines is critical.
  • Responsible for independent assessment of issues that may have significant impact on operations or create a significant amount of risk for the organisation.
  • Gather the information necessary to escalate an issue of critical importance or risk to the appropriate levels.
  • Maintain constant awareness of current landscape of the function, and begin to understand the needs of other disciplines.

To be successful in this role you should have:

  • In-depth knowledge of Good Manufacturing Practices (GMPs)
  • In-depth knowledge of manufacturing principles, concepts, industry practices, and standards
  • Strong computer, organisational, and management skills required.
  • Excellent verbal, written and interpersonal communication skills are required.
  • Have and maintain a full working knowledge of state-of-the-art principles and theories, applying such knowledge to the direction that supports the company's interests.
  • Demonstrate technical proficiency and creativity, collaboration with others and independent thought in suggesting new methods, processes, etc.
  • Must think critically and creatively, and be able to work independently, determine appropriate resources for resolution of problems and have strong organisational and planning skills.

You should have:

At least 8 to 10 years' experience in the pharmaceutical industry and a Degree or Master's qualification.