Process Engineer III

3 weeks ago

The Municipal District of Carlow, Ireland eTeam Full time

Job Description

Location: Carlow, Ireland

Work model: HYBRID - 2/3 days per week on-site (after the training period)

Type of contract: Temporary Employment Contract for 12 months with hourly rate

Our client: A global healthcare company committed to advancing medical innovation and improving patient outcomes through science-led initiatives. It focuses on developing life-changing medicines, vaccines, and biologic therapies across various therapeutic areas, including oncology, infectious diseases, diabetes, vaccines, and animal health.

ABOUT THE ROLE:

In this role, you'll make an impact in the following ways:

  1. This Technical Engineering role will play a key part in the development of the company drug product facility.
  2. Lead activities to deliver on the Tech Transfer requirements needed to support New Product Introduction into Carlow, including Tech Transfer, Validation programs & strategies, Technical support, and process improvement projects.
  3. Collaborate across functions, supporting, coaching, and facilitating project sub-teams to meet required project schedule milestones in accordance with applicable company standards for Quality and EHS compliance.

KEY RESPONSIBILITIES:

Safety

  1. Work collaboratively to drive a safe and compliant culture in Carlow.
  2. Collaborate with multiple partners in achieving excellence in technical transfer programmes.
  3. Serve as technical engineering representative for internal technical group discussions and represent Technical Engineering Carlow at Global Technical Forums as required.

Compliance

  1. Comply with Merck Global Policies, Procedures and Guidelines, regulatory requirements, and execute current Good Manufacturing Practices (cGMP).
  2. Complete documentation, conduct risk assessments, close out corrective actions, participate in audits and inspections, and proactively highlight compliance issues.

Process Engineering & Validation

  1. Lead and execute process engineering and validation activities to support technical transfers.

Projects

  1. Lead and manage multiple Technical Engineering projects needed to support the business at Carlow, including process improvements, capital projects, and Lean projects.
  2. Collaborate closely with cross-functional teams to establish scope in improvement projects at Carlow.

Continuous Improvement

  1. Manage and deliver on all technical/Validation/Quality Notifications/Change control/Project support within the technical engineering team.
  2. Sponsor and foster lean six sigma and standard work within the technical engineering Team.
  3. Drive collaboration between group functions and proactively look for synergies and innovative ways to work efficiently while remaining compliant.

Technical Expertise

  1. Act as a subject matter expert on Equipment Design, C&Q execution and planning, and Process design and validation.
  2. Serve as a liaison with global engineering services and specialist vendors on process requirements to deliver projects.

May be required to perform other duties as assigned.

ABOUT THE CANDIDATE:

General

  1. Considerable experience in a comparable role with a proven track record in leading a technical team through sustaining operations and technical transfer projects.
  2. Strong career history in pharma (ideally aseptic filling) and familiarity with a highly regulated environment.
  3. Innovative thinker with excellent decision-making and problem-solving skills.
  4. Experience of working in a cross-functional environment.
  5. Knowledge of and experience in applying Six Sigma and Lean methodologies.

Technical

  1. Knowledge of regulatory/code requirements to Irish, European and International Codes, Standards and Practices.
  2. In-depth knowledge and experience of Sterile filling processes and equipment, especially aseptic processing.
  3. Experience of executing and/or managing equipment and process validation in a sterile environment.
  4. Good shipping/Filter/Cleaning validation knowledge required.
  5. Excellent report, standards, policy writing skills required.
  6. Proficiency in Microsoft Office and job-related computer applications required.

People

  1. Ability to participate in highly-effective teams.
  2. Strong leadership and interpersonal skills.
  3. Willingness to support the team and a strong focus on delivering excellence.

Education

  1. Degree qualification or equivalent (Science, Engineering, Technical).
  2. Green Belt preferable.
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