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Pfizer Inc. Thermal Packaging Engineer Manager EMEA in Reno, Nevada

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

EEO & Employment Eligibility:

Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Pfizer is an E-Verify employer.

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