Job Description
Our client, a Biopharma company with EU HQ in Dublin, now seek a Packaging Engineering Contractor to work across all commercial products globally in a specific product portfolio, packaged within the internal Packaging Network and approved contract manufacturing organizations (CMO’s) throughout company global footprint.
Reporting to the Global Head of Packaging Engineering, this hire will function as Dublin-based Packaging Engineer SME. This is a contractor role, with ongoing requirement and opportunity to work in a rolling contract.
As an individual contributor this hire will be responsible to manage any/all impacted changes for the group, in US, EU and Rest of World markets in a product portfolio. This role is exclusively and solely in support of this product portfolio CMO Packaging Engineering, including projects/product supplied both from internal and external CMO operations.
Responsibilities for Global Packaging Engineer Contractor:
This role will manage all the documentation requirements of Packaging Engineers to facilitate Legal Entity Organization, MAH changes resulting from the Integration of multiple acquired organizations and products.
Knowledge of cGMP documentation requirements a must
Knowledge of developing and qualifying a sturdy packaging component a must
Management (development, review and approval of) new and modifications to technical profile drawings and purchasing/release specifications a must
Knowledge, experience and SME in electronic documentation, change control, deviation and CAPA a must (Trackwise a must; FOCUS, SPOT and EQMS/Veeva a plus)
Knowledge of Master Data documentation processes so as to modify master data (for serialized product) impacted by CMO changes
Ability to multi task and achieve tactical deliverables with little to no supervision, post training
Support team in substantiating and qualifying alternate component substrates, suppliers, and processes to mitigate risk of supply the development (input), launch, life cycle management and continuous improvement of primary and/or,
Lead or own change control, non-conformances and CAPA activities working with Quality and Global Labeling Operations
Manage implementation of platform (harmonization / standardization) components
Manage bill of materials, etc.
Candidate will facilitate template inclusion of regulatory (serialization)and global corporate standard labeling requirements (i.e. authentication)
Technical Expertise:
cGMP SME in packaging
Technical specification, profile drawing development (Auto Cad, etc.)
Specification development, review, approval and implementation
Trackwise (change control, deviation/investigation and CAPA initiation, review and approval mechanisms a must)
Interaction Must be a team player who can manage multiple tasks, a dynamic environment with a positive, outgoing spirit
Interacts closely and builds strong relationships with internal cross functional team members:
Forsters trust and confidence of peers and collaboration with other team members
Complexity (Products managed, mix of businesses, internal and/or external business environment, cultural considerations)
Demonstrated abilities to manage and collaborate across internal stakeholders such as packaging colleagues, quality...
Demonstrated strength in cross boundary communication, influencing others, working in cross-functional teams
Demonstrated organizational skills including project management.
Requirements for Global Packaging Engineer Contractor:
Bachelor’s Degree in an engineering related field; Packaging Engineers preferred.
5 years pharmaceutical experience (or equivalent).
Strong knowledge of cGMP documentation requirements.
Strong technical, interpersonal, communication and leadership skills.
Knowledge of electronic documentation systems (MUST: Trackwise).
Please contact Larry on +353 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
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