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Thermal Engineering Lead

Pfizer


Location:
Collegeville, PA
Date:
09/22/2017
2017-09-222017-10-21
Job Code:
1612996
Pfizer
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Job Details

Job Title Thermal Engineering Lead

JobID 1612996

Location: Collegeville, PA

Description **ROLE SUMMARY**

The Thermal Engineering Lead 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 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 all 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



+ **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



**Technical skills**



+ Bachelor's degree in Mechanical or Chemical Engineering

+ 7+ years experiences in Pharmaceutical Logistics, Thermal 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

**PHYSICAL/MENTAL REQUIREMENTS**

**Technical skills**



**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

+ Ability to lead meetings with senior-level personnel and can articulate issues and solutions to both team and 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



**Communication skills :**



+ Ability to translate technical and operational issues into summary level updates

+ Ability to communicate ideas in both technical and user-friendly language

+ Excellent written and oral communication skills are a must



**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



**OTHER INFORMATION**



+ Telecommuting will be considered for the right candidate



**EEO Statement**

**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.



**Sunshine Act**

Pfizer reports payments and other transfers of value to health care providers as required by federal and state transparency laws and implementing regulations. These laws and regulations require Pfizer to provide government agencies with information such as a health care provider's name, address and the type of payments or other value received, generally for public disclosure. Subject to further legal review and statutory or regulatory clarification, which Pfizer intends to pursue, reimbursement of recruiting expenses for licensed physicians may constitute a reportable transfer of value under the federal transparency law commonly known as the Sunshine Act. Therefore, if you are a licensed physician who incurs recruiting expenses as a result of interviewing with Pfizer that we pay or reimburse, your name, address and the amount of payments made currently will be reported to the government. If you have questions regarding this matter, please do not hesitate to contact your Talent Acquisition representative.



**Additional Offer Details:**



+ **Last Date to Apply for Job: September 20, 2017**

+ **Grade: 11**



A career at Pfizer offers opportunity, ownership and impact.



All over the world, Pfizer colleagues work together to positively impact health for everyone, everywhere. Our colleagues have the opportunity to grow and develop a career that offers both individual and company success; be part of an ownership culture that values diversity and where all colleagues are energized and engaged; and the ability to impact the health and lives of millions of people. Pfizer, a global leader in the bio-pharmaceutical industry, is continuously seeking top talent who are inspired by our purpose to innovate to bring therapies to patients that significantly improve their lives.



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


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