Sr / Principal Validation Engineer

Bachem; Vista (CA); On-site; USD 104,000 - 166,000; Full time

Benefits offered by this job

Medical/Dental/Vision

401(k) plan

Paid time off

Job summary

Bachem Americas is seeking a Sr / Principal Validation Engineer to support cleaning validation activities for API and PMO manufacturing, and to qualify equipment, facilities, and utilities. You will collaborate with Manufacturing and Engineering to plan and execute validation under the Quality Engineering scope of work, and to monitor validated systems.

The role requires 5+ years in CQV within GMP environments, with hands-on protocol writing, validation reports, and cross-functional leadership.

Qualifications

• Bachelor's degree in science or equivalent.
• 5+ years of CQV experience in a GMP/GDP environment.
• Experience with planning, writing and executing qualification protocols (IQ, OQ, PQ) and reports.
• Experience with validation / monitoring of critical pharmaceutical utility systems, including purified water, nitrogen systems and cold storage units.
• Experience with planning and execution of cleaning validation of production lab glassware and equipment including performance of validation studies, writing validation protocols and reports and other technical documents, as well as conducting validation related investigations (preferred).
• Experience with developing coupon spike and recovery studies for cleaning validation.
• Experience with Lean Six Sigma methods: root cause analysis, failure mode analysis and analyzing / organizing complex technical problems.
• Understanding of cleaning validation requirements for pharmaceutical industry.
• Knowledge of and ability to perform MAC calculation for APIs.
• Understanding of GMP for Active Pharmaceutical Ingredients per ICH Q7.

Responsibilities

• Develop strategy, establish acceptance criteria, generate, execute cleaning validation protocols and reports.
• Perform, coordinate, execute and analyze cleaning recovery studies.
• Lead cross-functional project teams to address issues and ensure on-time completion of all qualification / validation deliverables.
• Provide qualification / validation guidance and strategy during project planning and development phases. Train, coach and mentor Quality Engineer I and II.
• Write validation protocols and final reports, test methods, standard operating procedures, and technical reports.
• Planning, writing, and executing qualification protocols (DQ, IQ, OQ, PQ) and reports.
• Independently conduct and document investigations related to validation studies.
• Based on validation studies, evaluate and make recommendations for improvements to operations, processes and methods.
• Accountable for the accuracy and validity of testing results
• Support and assist with inspections and audits.
• Perform other related duties as assigned.
• Plan and perform required periodic re-validation / re-qualification activities
• Work and communicate with different associates within the company to ensure timely completion of assigned tasks and projects.
• Adherence to cGMP and safety procedures and contribute to GMP systems improvements.

Skills

CQV experience

Validation planning

Documentation writing

Lean Six Sigma

GMP knowledge

Critical utilities validation

Troubleshooting investigations

MAC calculation for APIs

QA collaboration

Education

Bachelor's degree in science

Master’s degree in science related field

Job description

A Brief Overview

The Sr. / Principal Validation Engineer fulfills a critical role in GMP operations, supporting cleaning validation activities for API and PMO manufacturing, and the qualification of equipment, facilities, utilities. This position will work in close cooperation with Manufacturing, Engineering, and other functional areas to plan and perform validation activities under the Quality Engineering scope of work. This individual must also monitor facility / utility validated systems, plan, write and execute validation/ qualification protocols, reports, and other technical documents, as well as conduct related investigations

The Sr. / Principal Validation Engineer fulfills a critical role in GMP operations, supporting cleaning validation activities for API and PMO manufacturing, and the qualification of equipment, facilities, utilities. This position will work in close cooperation with Manufacturing, Engineering, and other functional areas to plan and perform validation activities under the Quality Engineering scope of work. This individual must also monitor facility / utility validated systems, plan, write and execute validation/ qualification protocols, reports, and other technical documents, as well as conduct related investigations

What You Will Do

• Develop strategy, establish acceptance criteria, generate, execute cleaning validation protocols and reports


• Perform, coordinate, execute and analyze cleaning recovery studies.


• Lead cross-functional project teams to address issues and ensure on-time completion of all qualification / validation deliverables.


• Provide qualification / validation guidance and strategy during project planning and development phases. Train, coach and mentor Quality Engineer I and II.


• Write validation protocols and final reports, test methods, standard operating procedures, and technical reports.


• Planning, writing, and executing qualification protocols (DQ, IQ, OQ, PQ) and reports.


• Independently conduct and document investigations related to validation studies.


• Based on validation studies, evaluate and make recommendations for improvements to operations, processes and methods.


• Accountable for the accuracy and validity of testing results


• Support and assist with l inspections and audits.


• Perform other related duties as assigned.


• Plan and perform required periodic re-validation / re-qualification activities


• Work and communicate with different associates within the company to ensure timely completion of assigned tasks and projects.


• Adherence to cGMP and safety procedures and contribute to GMP systems improvements.

Qualifications

• Bachelor's degree in science discipline (chemistry, biochemistry, organic chemistry, biology, microbiology, chemical engineering or equivalent)


• Master’s degree in science related field (engineering, chemistry, biology or equivalent). (preferred)


• 5+ years of Commissioning, Qualification and Validation (CQV) experience in a GMP/GDP environment


• Experience with planning, writing and executing qualification protocols (IQ, OQ, PQ) and reports


• Experience with validation / monitoring of critical pharmaceutical utility systems, including purified water, nitrogen systems and cold storage units


• Experience with planning and execution of cleaning validation of production lab glassware and equipment including performance of validation studies, writing validation protocols and reports and other technical documents, as well as conducting validation related investigations (preferred)


• Experience with developing coupon spike and recovery studies for cleaning validation


• Experience with Lean Six Sigma methods: root cause analysis, failure mode analysis and analyzing / organizing complex technical problems


• Understanding of cleaning validation requirements for pharmaceutical industry


• Knowledge of and ability to perform MAC calculation for APIs


• Understanding of GMP for Active Pharmaceutical Ingredients per ICH Q7.


• Knowledge of the chemical composition, structure, and properties of substances and of the chemical processes and transformations they undergo, including use of chemicals and their interactions, danger signs, production techniques, and disposal methods.


• General lab instrumentation knowledge and operation experience.


• Capable of working methodically and adhering to rules and regulations.

Base salary range

Sr Engineer: $103,939 - $142,916
Principal Engineer: $120,875 - $166,204
Placement of new hires in these wage ranges is based on several factors including education, skill sets, experience, and training.

Total Rewards

We offer all Team Members a total rewards package including competitive pay, annual performance bonus, a generous benefit package with comprehensive Medical/Dental/Vision coverage, 401(k) plan with employer contribution, and paid vacation, personal and sick days.

Corporate Social Responsibility

Bachem takes responsibility for future generations by a careful handling of resources and avoiding environmental risks. We continually improve our ecological performance and develop and implement new approaches for enhancing employees’ environmental awareness. EcoVadis has awarded Bachem Gold Medal status in their assessment of Bachem.

Bachem Americas is an Equal Opportunity Employer

As an equal opportunity employer, we celebrate the diversity of our team and are committed to building an inclusive workplace where individuals are hired and advanced based on merit, skills, and qualifications. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, gender identity or expression, sexual orientation, national origin, genetics, disability, age, veteran status, or other legally protected status.