Project Engineer, Process Engineer

Project Engineer page is loaded## Project Engineer locations:
Irvine, CAtime type:
Full time posted on:
Posted Todayjob requisition :
R25 545"Expect to grow", personally and professionally:
At Siegfried, we offer exciting challenges and ample opportunities to showcase your talents. As a trusted and respected partner to the pharmaceutical industry, we uphold the highest standards in safety, quality and sustainability, while fostering a culture that empowers you to thrive. Join a rapidly expanding global company, where diverse perspectives and experiences come together in a collaborative environment. Here, you'll find a workplace that values both collective success and your individual contributions—offering long-term opportunities to grow and make an impact.
** Your Role:
** Scope and Purpose of Position  The Process Expert is responsible for managing production instrumentation, optimization of existing processes, and development of new processes. This scope includes initiation, scheduling, monitoring, and closure according to GMP, safety, and environmental requirements. The Process Expert should set a strong example for: determination to meet ambitious goals/timelines, customer service attitude toward colleagues, and motivation to help patients.
*
* Your Profile:

***** Responsibilities
* *** Own or support production documentation, including Master Batch Records, SOPs, risk assessments, protocols, reports, and other documentation as needed.
* Technical writing/reviewing to support production operations including, SOPs, qualification protocols, and batch records. Collect data for process qualification and implementation.
* Owning or supporting investigations related to material transfer, API production, drug substance formulation, drug product filling, inspection, and packaging.
* Support process optimization, development of new processes, and introduction of new technologies.
* Lead equipment qualifications and improvement projects. Support the execution of process validations.
* Responsible for all production instrumentation: IQ/OQ/PQ, owning equipment protocols/SOPs, coordinating PMs/calibration/requalification, maintaining inventory of spare parts, coordinating repairs, making minor repairs in-house. Provide guidance, support, training, and knowledge to Production team.
* Take a leadership role in managing multiple projects.
* Coordinate internal resources and third parties.
* Supervise work of contractors.
* Create/maintain comprehensive project documentation. Work with Quality to ensure readiness for inspections.
* Ensure that all activities are in compliance with GMP, FDA regulations
* Capable of being trained in production of API and aseptic final drug product.
* Support cross-functional teams to address all site-related activities, such as urgent events that require technical expertise.
* Willing to fill in on production team.
*** Required Knowledge,

Skills and Abilities

**** Understanding of Good Manufacturing Practices and ISO Standards
* Ability to push, pull or lift 50 pounds
* Understanding of aseptic processing or fill-and-finish operations
* Ability to be detail-oriented is essential
* Strong collaborative and influencing skills and ability to work well in a cross-functional, matrixed environment
* Strong written and oral communication skills and knowledgeable of data integrity.
* Ability to multi-task is essential
* Flexible and able to adapt to company growth and evolving responsibilities
* Knowledge of MS Word, MS Excel, MS PowerPoint, data collection, and statistical analysis
*** Required

Education and Experience
*** Bachelor's degree (biologic science or engineering discipline)3 years' experience in a process support or development role in GMP manufacturing and/or QA/QC Previous experience with qualifying instruments and processes in a manufacturing facility

Aseptic processes (equipment preparation, formulation, sterile filtration, and filling) experience is strongly preferred.

Understanding of manufacturing processes in pharma, GMP, quality and regulatory aspects.

Proficient in technical writing.

At ease with following detailed SOPs and completing extensive detailed documentation (e.g., batch records) and…