Blister Packaging Lead Engineer
|Contact Name:||Larry O’Leary|
Our client, a Biopharma company based in Munster region with strong development pipeline and multiple blockbuster products, now seeks an experienced Engineer who will lead new product introductions of blister packaging technology fand supporting product launches.
The successful candidate will provide leadership and guidance to Blister Packaging team, contributes to the development of department strategies
The ideal candidate will be a subject matter expert with Blister Packaging technology, with demonstrated technical engineering knowledge of both Primary & Secondary Blister technology and experienced in transitioning such technology into pharmaceutical operations and supporting the area as required.
Requirements for Blister Packaging Lead Engineer:
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
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.
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
Subject Matter experience in Blister Packaging (Primary & Secondary) i.e; Thermoforming, Heat sealing, Digital printing, Tablet feeders and / or Tablet inspection systems
Prior experience in a cGMP related industry is desirable, within Biopharmaceutical or Pharmaceutical industry preferred.
Must possess a strong knowledge of the FDA and cGMP standards as well as regulatory guidance documents.
Audit and Investigation Skills, Report Writing Skills.
Strong verbal, technical writing and interpersonal skills are required.
Proficiency in Microsoft Office applications.
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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