MS&T Engineer

4 weeks ago

Pomona, United States Dechra Pharmaceuticals Full time

Job Introduction

Thanks for checking out our vacancy, we're delighted you want to learn more about Dechra Pharmaceuticals.

Dechra is a growing, global specialist within the world of veterinary pharmaceuticals. Our expertise is in the development, manufacture, marketing and sales of high quality products exclusively for veterinarians worldwide.

Here at Dechra, our values are embedded within our culture and thrive within our family of almost 2000 colleagues globally. From manufacturing to marketing, (D)edication, (E)njoyment, (C)ourage, (H)onesty, (R)elationships and (A)mbition are at the heart of our everyday operations and the way we do business

Our manufacturing facility in Pomona is recruiting for an experienced MS&T Engineer to join us for an 18-month remediation project. The successful candidate will be supporting process improvement projects and completing outstanding out of specification investigation.

Role Responsibility

The successful candidate will have a broad and varied scope of responsibilities including but not limited to:

Takes charge of technology transfer, performing facility fit and gap analyses, and authoring critical documentation such as Risk Assessment, OOS Investigation, Process Validation protocols etc.

Support/Lead resolution of deviations, investigations, and process issues.

Drives the strategy and daily operations of the MS&T arm of the Continuous Manufacturing Process team.

Manages the entire life cycle of equipment procurement, including vendor evaluation and FAT/SAT/CQV/Validation support.

Collaborates across various departments like Manufacturing, Quality, and Project Management to ensure project success.

Provides GMP support and focused on process optimization.

Generate and maintain documents related to GMP Manufacturing executions, product impact assessments.

Participate in the project team meetings, decisions, and creation of milestones representing MSAT.

Process training, as needed, in adherence to company policies and quality requirements.

Define and provide user requirements for process equipment associated drug product manufacturing.

Prepare and present data associated with manufacturing processes to internal and external teams as requires.

Key Performance Indicators

A strong track record in technology transfers, inclusive of drafting detailed process documentation and analyses.

Must be self-motivated, organized and proactive.

Ability to coordinate multi-departmental tasks and deliverables (interaction with Manufacturing, Process Development, Engineering, Supply chain, QA, QC, etc.).

Demonstrated ability to build effective working relationships across departments (Manufacturing, QA, Process Development, Project Management and Business Development) to support processes and products.

The Ideal Candidate

Here at Dechra, we welcome applications from candidates from a range of backgrounds, we are particularly interested to hear from those who have:

Ability to provide technical training to others on GMP manufacturing operations

Extensive experience in GMP manufacturing and compliance with demonstrated knowledge and experience related product development of pharmaceutical manufacturing

Demonstrated experience leading troubleshooting efforts

Strong communication skills necessary to interact with internal stakeholders

Dechra Pharmaceuticals PLC

Apply

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