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PASX Engineer at Framingham, Massachusetts, USA
Email: [email protected]
From:

Cauvery Priyadarshini,

Vyze Inc.

[email protected]

Reply to:   [email protected]

Hi,

This is Cauvery from Vyze Inc.

Please
find the below position
, if youre comfortable with the JD kindly revert me bacK
.

Job Description -

Job Title: PASX Engineer

Visa: No H1B, CPT

Location: Framingham, MA (Hybrid)

MOI: Skype

Responsibilities include:

Problem Solving:

o Provide technical solutions to a wide range of difficult problems through individual efforts as well as strategic leveraging of outsourced personnel. Solutions are imaginative, thorough, practical, and consistent with organization objectives.

Production:

o Responsible for ensuring MES and potentially other manufacturing related computerized systems are available to support Operations Schedule Adherence requirements.

o Managing small to medium projects related to MES and ensuring that the appropriate controls, approvals, and validation requirements are implemented.

Training /Deviations /Compliance:

o Complying with Sanofi requirements for training, maintaining training at or above 95% on time.

o Utilizing quality systems to measure, analyze, and improve team performance.

o Participate in staff meetings, providing updates of department activities and project statuses.

o Ensuring that Process, Equipment and MES documentation is compliant and inspection ready.

o Participating in inspections conducted by external regulators.

o Partnering with direct and indirect management chain to ensure the following:

Designing Department Training Plan and managing execution.

Ensuring Inspection Readiness of assigned areas.

Overseeing completion of investigations and deviations.

Safety

o Complying with requirements from Sanofi's Safety Program including Health and Safety regulations and OSHA requirements.

Continuous Improvement:

o Working collaboratively with inter-department and cross-functional teams to lead necessary changes in a timely and productive manner.

o Identifying opportunities to improve manufacturing processes and practices.

o Ensuring all manufacturing management tools/systems and documentation (SOPs, MBR's, OJTs) is accurate.

o Partnering with Manufacturing to troubleshoot and drive resolution of process issues and proactively driving projects to improve manufacturing process.

o Partnering with Operational Excellence to drive business process improvements through Kaizens, Kanban, 5S and VSM in their area of responsibility.

o Ensuring that internal customers and suppliers are aligned with the solutions and services of the department.

Basic Qualifications:

Bachelors degree in Engineering, Science and 1 to 2 years relevant work experience or 5 years of relevant work experience.

1 year of electronic batch record editing experience with MES Systems Koerber/Werum PASX

Direct experience with regulated environments (i.e. cGMP, OSHA, EPA).

Demonstrated knowledge of validation requirements for control systems in CGMP and/or ASTM environments.

Preferred Qualifications:

Masters with 1+ years of relevant work experience.

MES Koerber/Werum PAS-X batch record editing experience.

Experience in OSI PI system maintenance and configuration activities

Experience with DCS systems

Experienced in establishment of safe practices in a cGMP environment.

Proficient working with computer programs/applications such as Windows, VBA, MS Word, Excel, Access, etc.

Thanks and Regards.

Cauvery Priyadarshini

US IT Recruiter

Vyze INC (An E- VerifiedCompany)

Email:
[email protected]  

25179 Methley Plum Place, Aldie, VA 20105

www.vyzeinc.com

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Wed Aug 30 06:14:00 UTC 2023

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