12 days old

MES Engineer

Pfizer
Andover, MA 01810
**ROLE SUMMARY**



+ The site MES SME (subject matter expert) requires an in-depth knowledge of the system; understanding User Requirements and Manufacturing Processes; designing and developing building blocks; designing Functional Testing documentation and execution of those plans; developing Recipe Approach; applying Family Approach to Configuration Documentation and testing; development of Training Materials and delivery of training to End-Users.



**ROLE RESPONSIBILITIES**



+ Collaborating with other sites to maintain a high degree of system reusability and replication, ensuring consistency.

+ Seen as a resource for all departments

+ Defines scope of work for upgrades, including (but not limited to): recipe revisions, remediation plan for recipes, SAP impact, MCS impact, QA impact, SOP impact and revision remediation plans.

+ The EBR Specialist - Recipe Author for Electronic Batch Records is responsible for generating and maintaining Commercial, Clinical, and/or Development production recipes per Standard Operating Procedures, project timeline and Production Schedule.

+ Work on interdisciplinary self-directed teams, to define and implement process improvements and participate in process troubleshooting.

+ Provide some detailed engineering on change controls and limited functionality upgrades to existing systems.



**BASIC QUALIFICATIONS**



+ BS in computer engineering, mechanical, electrical engineering, bio-engineering or relevant discipline is required

+ Minimum of 5 + years of experience with MES (Manufacturing Execution Systems) pharmaceutical process systems executing design, commissioning, troubleshooting, and/or sustainable activities is required

+ **Or** Candidates with a Bachelor's Degree must have a minimum of 8+years of experience in a pharmaceutical process systems relevant position with MES experience is required

+ 2 years of working knowledge of cGMP type systems and practices is required



**PREFERRED QUALIFICATIONS**



+ Computer skills, ability to work across functional areas such as operations, maintenance, and validation are required to provide appropriate support

+ Good process knowledge about bio-manufacturing

+ Candidates should also be familiar with relational database such as SQL or Oracle

+ Good communication skills, verbal and written

+ MS degree with 5+ years of experience is preferred



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



+ The position may require some off-shift support and/or remote support.



**OTHER INFORMATION**



+ Last date to apply: 4/11/21



**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

Categories

Posted: 2021-03-31 Expires: 2021-04-30

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MES Engineer

Pfizer
Andover, MA 01810

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