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Validation Engineer

Company: PharmEng Technology
Location: Berkeley
Posted on: January 9, 2022

Job Description:

PharmEng Technology has been providing quality services to leading manufacturers of healthcare and pharmaceutical products since 1997. Our specialists hold expertise in Commissioning & Qualification, Validation, Quality Systems, Regulatory Affairs, Engineering, and Training to ensure that our clients can keep on providing the world with their cost-effective and high-standard healthcare products.

At PharmEng Technology, we strive to cultivate the best working environment where empowerment, passion and perseverance are nurtured -while serving our clients to achieve their unique business goals. - We are seeking mid to senior level Validation Engineers/Consultants for opportunities in the San Francisco Bay area.

Objectives of this Role:

Utilize engineering, vendor, and client specifications to generate and execute testing protocols for process systems, process equipment and utility systems following client procedures and good documentation practices.
Assist in deviation root cause analysis and corrective action plans.
Generate final and summary reports for executed test protocols.
Provide technical and compliance input into project execution strategies to ensure regulatory requirements are met.
Generate and support higher level project documentation as required such as Masterplans, schedules, and summary reports.
Work in the full range of project phase execution including CQV, CTP and project hand-over activities.

Skills and Qualifications:

Bachelor's degree in Engineering (Chemical, Mechanical or Biochemical) or similar discipline required.
3-10+ years' experience within the pharma/biotech/medical device industries.
Experience writing and executing commissioning, verification, and validation protocols and associated reports.
Familiar with integrated commissioning and validation as well as ASTM E2500 verification methods.
Experience utilizing risk-based methodologies in testing.
Experience with manufacturing processes and equipment such as CIP/COP systems, filtration skids, chromatography, fermentors/bioreactors, sterilization, and lyophilization equipment
Experience with hygienic utility systems such as purified water, WFI, clean steam, and process air.
Experience with testing equipment and software such as Kaye Validators and Dataloggers.
Proficient with Microsoft Office (Word, Excel, etc.).
Travel may be required on occasion.
Permanent FTE or temporary/contract options available.
Experience with gene therapy / cell therapy and CSV is a plus.

Why PharmEng Technology?
Our consultants come from different areas of the Pharmaceutical/Biotech/Medical Device industries and have extensive experiences obtained from world-class organizations in North America, Europe, and Asia. -At PharmEng Technology, we value everyone's unique talents and work together to support our clients. -We offer continuous career growth, competitive wages, opportunities for travel and a team mentality that sets us apart from our competitors. -It is the growth of our staff that continues to grow our company globally.

What We Have:

Comprehensive benefits package & competitive wages
A supportive environment where employee growth is promoted
PTO & paid holidays
Other great incentives

Company Response to Covid-19
While we serve industries deemed essential businesses, PharmEng Technology will follow safe business practices and adhere to local, state, and federal guidelines. -When possible, PharmEng Technology will allow remote work from home.

EEOC Statement
At PharmEng Technology, we don't just accept difference - we celebrate it, we support it, and we thrive on it for the benefit of our employees, our clients, and our community. PharmEng Technology is proud to be an equal opportunity workplace.

Keywords: PharmEng Technology, Berkeley , Validation Engineer, Engineering , Berkeley, California

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