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Validation Engineer II, QA

Bachem is a listed technology-based company focused on peptide chemistry. The company provides a full range of services to the pharma and biotech industries. It specializes in the development of innovative, efficient manufacturing processes and the reliable production of peptide-based active pharmaceutical ingredients. A comprehensive catalog of biochemicals and exclusive custom syntheses for research labs complete the service portfolio. Headquartered in Switzerland with subsidiaries in Europe, the US and Asia, the group has a global reach with more experience and know-how than any other company in the industry. Towards its customers, Bachem shows total commitment to quality, innovation and partnership.

In order to continue our organic growth, we are constantly looking for talent.

Your Responsibilities

The Validation Engineer II fulfills a critical role in GMP operations. This individual must plan and execute validation studies, write validation protocols, reports and other technical documents, as well as conduct validation related investigations. The incumbent is responsible for managing the cleaning validation activities in a GMP environment including cleaning cycle development, execution of protocols and review and approval of reports. The incumbent will contribute to improvements in operations, processes and methods.

 

Your Tasks

Provide equipment, facilities/utilities qualification guidance and strategy during project planning and development phases

Independently develop cleaning validation strategy for equipment and parts

Develop and execute cleaning validation protocols and generate validation reports

Independently plan and execute validation studies for equipment, facilities/ utilities and cleaning

Manage contractors performing equipment and system qualifications

Write validation protocols, validation final reports, Standard Operating Procedures (SOPs), and technical reports

Review and approve validation documentation (requirements specifications, risk assessments, validation plans, IQ, OQ, and related reports, and validation summary reports, etc.) using defined procedures

Independently conduct and document investigations related to validation activities

Contribute to GMP systems improvements

Train operations staff on protocols, procedures and technical details related to systems, equipment and cleaning processes

Support the change control process by reviewing proposed changes, performing risk assessments, and assessing the adequacy of verifications and validations

Demonstrates commitment to the development, implementation and effectiveness of Quality Management System per ISO, FDA, and other regulatory agencies requirements

 

Your Profile

Bachelor’s Degree in science related field (Engineering, chemistry, biology or equivalent)

Minimum of 4 years of pharmaceutical validation experience (cleaning, equipment and facilitates/ utilities)

2-4 years of related experience in Engineering, manufacturing or quality

Experience with root cause analysis, failure mode analysis, verification and validation

Experience in drug GMP manufacturing

Experience in writing standard operating procedures and technical reports

Experience in validation, particularly cleaning validation

Excellent written and oral communication skills

Basic computer knowledge, including Microsoft Word, Excel and PowerPoint

Ability to effectively organize, multitask, and work in a fast-paced, deadline driven work environment

Ability to communicate in a proactive and solution-focused manner, including keeping management aware of potential issues

Detail oriented with the ability to troubleshoot and resolve problems

Ability to work independently and manage one’s time

Communicate effectively and ability to function well in a team environment

 

Preferred:

Master’s Degree in science related field

Six Sigma Green or Black Belt

 

We Offer

You will be part of a motivated team overseeing the entire development cycle of respective APIs. If you are looking for a new challenge and want to join a motivated team in an internationally renowned company, you should seize this opportunity.


Nearest Major Market: San Diego