20 days old

Thermal Packaging Engineer Manager EMEA

Pfizer
Myrtle Point, OR 97458
**The Thermal Packaging Engineering will be responsible for the following:**



+ Support the thermal qualification of controlled temperature shipping systems for Intercompany Operations and In-Market distribution

+ Maintaining portfolio of new product launches (NPL) with Global Launch Operations (GLO) with a focus on biologics and biosimilars

+ Supporting timely filing of MLA/BLA, and other MOH/BOH licensing and regulatory amendment applications

+ Establishing global strategies for selecting thermal packaging conveyances supporting PIH and PCH New Product Launches

+ Establishing bracket methodologies and matrices for thermal conveyance qualifications as part global product registration and regulatory dossiers filings

+ Establish requirements for global thermal profiles per global MOH and BOH requirements in support of qualification and thermal bracketing strategies

+ Ensure the execution of shake/drop and shock/vibe studies are executed per ASTM standards

+ Support thermal studies across the network to support Zero Defects Strategy

+ Responsible for compiling data to be filed in the Qualification and Validation section of Shipping Solutions in regulatory dossiers.

+ Role has direct responsibility for Control Tower operational support of in transit incidents, and intervention. This includes nonstandard business hour support (e.g. weekends) as required.



**ROLE RESPONSIBILITIES**



+ **New Product Launch (NPL) Support:**

+ Oversee the deployment of controlled temperature shipping technologies including the identification, selection, qualification and implementation of solutions to support Business and Operational unit requirements

+ Work with Bio Tx, Pharma Tx, Consumer Health and Animal Health teams to provide controlled temperature shipping technology perspectives and support for new products

+ Serve as the technical representative to support GTS for controlled temperature logistics

+ Act as a key interface/SME for controlled temperature shipment technologies between Business and Operational units for NPL's

+ Responsible for executing data models using global seasonality data for the development of temperature control solutions

+ Leverage controlled temperature shipping component supplier capabilities in the initiation and evaluation of system development/improvements

+ Establish strategy for the execution of IQ/OQ/PQ for new product launches and regulatory amendments

+ Role has direct responsibility for Control Tower operational support of in transit incidents, and intervention. This includes nonstandard business hour support (e.g. weekends) as required.



+ **Validation and qualification support**

+ When required, will author operational, performance qualification protocols and reports.

+ Responsible for drafting technical documentation supporting qualification strategies established by LSC launch or regional leads

+ Ensures logistics compliance with regional regulatory requirements where accountable



+ **General Operations Support**

+ Real time shipment intervention and ensuring follow up actions with transportation suppliers are actioned against predefined playbooks and Standard Operating Procedures.



**Technical skills**



+ Master's degree in Thermal Engineering or related packaging preferred or

+ Bachelor's degree, 3+ years experiences in Pharmaceutical Logistics, Thermal Packaging Engineering, Transportation or Supply Chain management in an international environment with experiences on temperature controlled/cold chain logistics and Transport Qualification.

+ In depth knowledge of a broad range of controlled temperature shipping components, systems, monitoring equipment, best practices and governing regulations

+ In depth understanding of the regulatory guidelines impacting the requirements for qualifying and utilizing temperature control shipping systems

+ Understand the concepts of product label claim and stability data and how to apply to the qualification process

+ Understanding of processes used in development and qualification of controlled temperature shipping systems

+ Proven project management and complex problem solving skills

+ Impeccable technical writing skills

+ Ability to effectively manage and influence cross functional teams

+ Effective verbal and written communication

+ Can evaluate the latest technology advances and apply industry principles and applications

+ Can determine areas of potential risk to business success and generate gap analysis

+ Subject matter expert in relevant materials, design and principles



**Technical functional skills :**



+ Can analyze operational process problems and provide support in determining appropriate corrective and preventative actions

+ Demonstrate knowledge through practical application

+ A propensity to pursue goals with energy and persistence

+ Willingly share information and ideas with colleagues

+ Can articulate the issues and solutions to both the team and to senior management

+ Maintains clear communication with customers (internal and external) and monitors customer expectations



**Interpersonal skills :**



+ Strong leadership acumen with the ability to lead cross functional meetings to drive strategic decision-making

+ Must be detailed oriented with the ability to translate regulatory requirements into logistics strategy

+ Ability to work with multi-cultural teams and collaborative environment

+ Ability to work in a matrixed organization

+ Interacts with others in a transparent, honest and authentic fashion. Ensures stakeholders are confident of one's intentions as well as those of the organization

+ Understands and acknowledges the differing needs of stakeholders and works to achieve success in a mutually beneficial manner

+ Highly organized and ability to prioritize activities on a daily basis



**NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS**



+ Must be able to work in a global environment across multiple time zones

+ Up to 25% travel

+ Nonstandard business hour support (e.g. weekends) as required



**What we offer**

In addition to competitive salaries and customized benefits packages, we offer a supportive and diverse culture and unparalleled career development opportunities.



We offer you a challenging job in an international and complex environment within a dynamic team.



Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.



**"For all our projects regarding diversity and inclusion on the work floor, Pfizer is closely collaborating with Actiris."**



**\#LI-PFE#LI-REMOTE**



Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.



Logistics & Supply Chain Mgmt

Categories

Posted: 2020-10-05 Expires: 2020-11-04

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Thermal Packaging Engineer Manager EMEA

Pfizer
Myrtle Point, OR 97458

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