Manufacturing Engineer lll

Contract Type: Permanent
Location: Münster
Contact Name: Larry O’Leary
Contact Email: larry@rftgroup.ie

Job Description

Manufacturing Engineer lll

Our client, a Biopharma company based in Munster region with strong development pipeline and multiple blockbuster products, now seeks an experienced Manufacturing Engineer with blister pack experience.

Job Spec
  • Works within operations team on the Primary & Secondary Blister packaging line
  • Manages operation delivery KPIs for Blister Packaging
  • Manages safety metrics, complies with all safety and GMP regulations
  • Manages compliance metrics for Blister Packaging
  • Manages and executes training & development of Packaging team running the Blister Packaging Line
  • Supports & leads process deviations and investigations (technical support)
  • Reports on a regular basis on line performance, and reports any issues that need to be resolved & highlighting where support is required
  • Manages & coordination of resolution of material related issues
  • Manages the optimization of Blister Line performance (OEE & optimizing yield / minimizing waste)
  • Works with supply chain planning the line & measuring execution of the locked plan
  • Performs evaluation studies and trouble shooting on manufacturing process, equipment and systems
  • Independently resolves manufacturing issues of complex scope
  • Independently manages assigned projects through completion
  • Participates on cross-functional project teams
  • Coordinates cross-functional efforts to support new product introductions in Blister Packaging to support product launch
  • Contributes to the development of department strategies
  • May participate in audits to include internal, vendors, contract manufacturers.
  • May review and approve batch record and processing documentation, including planned or unplanned deviations.
Key Differentiating Contributions
  • Requires an extensive understanding and application of Blister Packaging, concepts, practices and standards.
  • Demonstrates advanced technical knowledge (Primary & Secondary Blister technology)
  • Demonstrated success in leading investigations and problem resolution
  • Works on complex problems where analysis of situations or data requires in-depth evaluation of various factors, considerable judgment is required in resolving problems and making routine recommendations
  • Provides leadership and guidance to Blister Packaging team
  • Demonstrates the ability to clearly and concisely present/ explain process/product features, performance and deviations to multiple internal audiences.
  • Demonstrates an ability to communicate effectively with peers in the organization.
  • Demonstrates the ability to think outside of the process and consider the impact decisions will have on other areas

Person Spec
  • Proficient knowledge of Good Manufacturing Practices (GMPs)
  • Audit and Investigation Skills, Report Writing Skills.
  • Strong verbal, technical writing and interpersonal skills are required.
  • Proficiency in Microsoft Office applications.
  • Must possess a strong knowledge of the FDA and cGMP standards as well as regulatory guidance documents.
  • A good level of relevant experience in Blister Packaging (Primary & Secondary)
    • Thermoforming
    • Heat sealing
    • Digital printing
    • Tablet feeders
    • Tablet inspection systems
  • Prior experience in a cGMP related industry is desirable, within Biopharmaceutical or Pharmaceutical industry preferred.

Please phone Larry on +353 (0)1-2302400 / larry@rftgroup.ie
The RFT Group, BioPharmaceutical Division specialise exclusively in the recruitment of scientists, engineers and executives for the biotechnology, pharmaceutical and medical device sectors. www.rftgroup.ie
Follow us on: Facebook, Linked-in, twitter