Manufacturing Quality Engineer / Pharma Industry

Company: Pioneer Data systems
Location: Raritan
Posted on: September 19, 2023

Job Description:

Our client, a world-leading Pharmaceutical Company in Raritan, NJ is currently looking for a Manufacturing Quality Engineer to join their expanding team.

Position Details:
Job Title: Manufacturing Quality Engineer / Pharma Industry
Duration: 12 months contract, extendable up to 24 months
Location: Raritan, NJ

Note:
The client has the right-to-hire you as a permanent employee at any time during or after the end of the contract.
You may participate in the company group medical insurance plan

Job Description:
External Quality Person-in-Plant

Day-to-Day tasks:
On-site shopfloor Quality oversight for site and process qualification activities and commercial product manufacturing for CAR-T at an external site.
Support on-site quality oversight for day-to-day production activities, including deviation and CPA review, escalation of critical issues, batch record review, release support and change control.
Support monitoring of EM quality performance and proactively identify risks.
Influence and build relationship with internal and external partners to continuously enhance quality performance.
Interface with other functions (Operations, Planning, Technical Operations, etc.) within Janssen as well as the external manufacturer
Apply cGMP regulations and other FDA and international requirements to all aspects of the position.

Required:
Bachelor's degree with a concentration in engineering, science, or an equivalent technical discipline
Minimum of 8 years working in drug substance and/or pharmaceutical manufacturing
Experience in pharmaceutical aseptic manufacturing operations and quality assurance
Detailed knowledge of cGMPs related to pharmaceutical production
Strong interpersonal and written/oral communication skills
Ability to quickly process complex information and make critical decisions with limited information and in a complex and time-sensitive environment

Preferred:
Experience in Good Tissue Practices

Experience in biologic/vaccine/cell culture products

Keywords: Pioneer Data systems, New Brunswick , Manufacturing Quality Engineer / Pharma Industry, Engineering , Raritan, New Jersey