Packaging Engineering Manager - European Contract Manufacturing support
Global pharma & healthcare leader, the main purpose of this role is to provide packaging engineering technical support to Contract Manufacturing Organization (CMO) & Supplier Relationship Teams (SRT) within Europe in order to avoid business interruptions due to packaging related issues at Contract Manufacturing Organizations.
Responsible for overseeing technical aspects of technical transfers for packaging processes to contract manufacturer sites, major packaging equipment installations/upgrades, and packaging material projects necessary to maintain and improve quality, productivity and costs within the CMO network. Collaborates with SRT cross-functional team members to provide risk analysis guidance and recommends decisions concerning packaging validation activities, and packaging material/process changes. Manage technical packaging support for commercial supply via European based contract (external) manufacturing sites.
Includes oversight of various dosage forms (solids, liquids, powders, semi-solids, etc.), various primary packaging formats (Rigid containers, flexible pouch/sachets, tubes, blisters, etc) along with secondary and tertiary packaging.
The Packaging Engineering Manager provides technical subject matter expertise to the Contract Manufacturing Organization. Major responsibilities for this role are:
• Provides packaging engineering support to CMO Supplier Relationship Team(s) and QA on issues related to packaging materials, packaging equipment and packaging processes at contract manufacturing sites in order to meet the production schedule.
• Utilize statistical analysis tools to support evaluations of validation efforts, process capabilities evaluations, etc.
• Act as lead subject matter expert to support QA as needed on deviations and/or quality issues related to packaging materials and/or processes. Ensures robust investigations are executed at the contract manufacturer to ensure correct root cause(s) are identified and appropriate corrective/preventative actions (CAPA’s) are in-place.
• Provides packaging engineering support for product transfers to and from contract manufacturer sites; including oversight of technical documentation related to packaging portions of transfers.
• Lead technical activities related to packaging material changes at CMOs and liase with regulatory and quality departments for all packaging related required change controls. Execute technical assessments for changes included validation impact assessments, etc.
• Support major package design change projects for commercialized products (e.g. post-launch) including generation of Bills of Material, packaging specifications and artwork changes.
• Initiate and perform innovative packaging materials and equipment projects which ensure improved efficiencies and cost savings, while meeting all quality and regulatory compliance requirements. Act as primary technical liaison with contract manufacturer and packaging material supplier for changes.
• Collaborate with R&D colleagues early on for new product development and act as lead commercial packaging expert on applicable R&D projects to ensure robust product launches at contract manufacturing sites.
• Keep abreast of current technology and innovations in pharmaceutical packaging materials and equipment and provides technical leadership on CMO packaging projects.
• Keep abreast of cGMPs, current packaging regulations from health authorities, and local governments, including but not limited to container/closure change requirements, child-resistance, tamper-evidence, serialization, leachable/extractables, etc.
• Collaborating with CMO technical services colleagues and QA to define the sampling plans and documentation of validation studies for packaging equipment and/or processes at contract manufacturers.
• Maintains a level of technical excellence by proper training, can act as a reference person for given technologies, and trains the CMO and technical services organizations on packaging technology.
Skills, experience, qualificatons required .....
Education in technical fields applied to the industry, candidates from pharmaceutical world, medical devices, food industry, fast consumer goods or cosmetic
Operational experience in one of these industries linked to the supply of the product if possible, production, quality, maintenance, engineering, ideally in close contact with the packaging and or the transport of product, R&D if applied to packaging problematic can be ok
4-7 years experience in one of these industries, 1st or 2nd job
Qualification and / or Validation principle knowledge and understanding would be an asset for that position
Packaging experience : launch of product, R&D, production support, packaging batch records, management of packaging operators....
Knowledge of the regulations applicable in the field of application : GMP bases the pharma, ISO in the food, ICH standard for cosmetic, Medical devices would be an advantage
Root Cause Analysis capability, understanding of what a “Change Control Process” is about, would be highly appreciated
Evidence of delivery in significant internal or external projects, can demonstrate a certain level or potential of personal and professional maturity and also autonomy to work remotely from senior managers based in other locations is essential
BSc/MSc in Packaging Science, Packaging Technology or equivalent.
Experience in Packaging Operations and/or Engineering in a GMP pharmaceutical environment; experienced in leading technical effort for change controls and deviations in a GMP environment.
• Broad knowledge of packaging engineering as applied to pharmaceutical package equipment and materials. Experience in packaging equipment qualification and packaging process validation.
• Experienced in authoring packaging material specifications and Bills of Materials.
• Thorough understanding of the relationship between product, packaging process, packaging equipment and packaging material.
• Good understanding of industry practices and regulations (e.g. GMP, ISO, ICH, Child Resistant, Tamper-Evident, etc.) across multiple health authorities (e.g. FDA, EMEA, Health Canada, etc.)
• Strong project management, interpersonal, communication, negotiation and problem solving skills.
• English speaker
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