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.
- 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.
- 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
- 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)
- 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 / firstname.lastname@example.org
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
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