4 days old

Senior Validation Engineer

Pfizer
Andover, MA 01810
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**ROLE SUMMARY**



Andover Liquid Dosage Manufacturing (AN-LDM) Engineers are responsible for providing engineering solutions that enable successful and innovative manufacturing within Pfizer's state-of-the-art large molecule early stage clinical drug product manufacturing facility.



Engineers are responsible for managing the lifecycle of all relevant facility equipment and systems and ensuring all efforts are completed in a compliant manner.



**ROLE RESPONSIBILITIES**



+ Participate/lead in all validation activities, including but not limited to writing, executing and reporting on qualification work for equipment/systems such as:

+ Facilities/Utilities

+ Vial Washers

+ Depyrogenation Tunnels

+ Filling Machines

+ Labelers

+ Process Control System (SCADA)

+ Controlled Temperature Units (CTUs)

+ Quality Control/Laboratory Equipment (HPLCs, etc.)

+ Lyophilizers

+ Autoclaves

+ Steam-in-Place/Clean-In/Out- of Place (SIP/CIP/COP)

+ Participate/lead in cross-functional teams, working effectively in a highly matrixed team environment to advance Pfizer's clinical portfolio.

+ Provide engineering solutions at various scale, as both an individual contributor and/or as a member of a larger team. Engineering efforts will include all manufacturing operations required to produce drug product for clinical supply. Exposure will include non-sterile, aseptic, and sterile processing steps.

+ Interact directly with manufacturing, identifying opportunities to expand capability and increase efficiency

+ Participate in aspects of process equipment and facility lifecycle, including specification, design, procurement, commissioning, qualification, sustainable maintenance, decommissioning, and retirement

+ Adhere to and continuously review local policies to conform against a center-based quality and standards unit. Beyond conforming, policies should also be reviewed to ensure alignment with modern engineering practice.

+ Create and maintain appropriate documentation to reflect as-built conditions for all relevant systems



**BASIC QUALIFICATIONS**



+ Degree in an engineering, scientific or related discipline. Experience in regulated pharmaceutical/medical device industry

+ Bachelor's Degree, 9+ years of relevant experience

+ Master's Degree, 7+ years of relevant experience

+ Doctorate, 4+ years of relevant experience

+ Exposure to and aptitude in core engineering lifecycle competencies

+ Scientific and mathematical analysis

+ Specifications and build documents

+ Design

+ Implementation



**PREFERRED QUALIFICATIONS**



+ 15+ years in regulated pharmaceutical industry

+ Demonstrated experience in a matrix team environment and interacting with Process Development, Project Management, Manufacturing, Regulatory, Compliance, and Quality

+ Strong attention to detail, along with excellent communication and collaboration skills

+ Strong decision-making skills, routinely demonstrated in highly complex environments

+ Ability to work independently and complete deliverables with little guidance



**PHYSICAL/MENTAL REQUIREMENTS**



+ Collaborative skills and effective partnering skills in complex working environments

+ Ability to work in a dynamic multi-discipline organizational model

+ Ability to focus in an open concept work environment



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



+ Flexibility to occasionally perform weekend work and 2nd shift work

+ Minimal travel required

+ Ability to gown to enter non-aseptic and aseptic areas of the manufacturing facility.

+ Must be able to stand for extended periods of time, as needed, while performing job tasks



**Other Job Details:**



+ **Last Date to Apply for Job: June 28, 2021**

+ Eligible for Employee Referral Bonus

+ \#LI-PFE



**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.



**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.



Engineering



\#LI-PFE
Posted: 2021-06-11 Expires: 2021-07-12
Sponsored by:
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Senior Validation Engineer

Pfizer
Andover, MA 01810

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