Senior C&Q Validation Engineer – GMP Analytical & Process Equipment- (JP15147)
Share
Job Location:
Thousand Oaks, CA - USA
Hourly Salary:
$ 60 - 65
Posted on:
4 days ago
Vacancies:
1 Vacancy
Job Summary
Job Title: Senior C&Q Validation Engineer GMP Analytical & Process Equipment- (JP15147)
Location: Thousand Oaks CA. 91320 (Hybrid)
Employment Type: Contract
Business Unit: Engineering Systems
Duration: 1 year (with likely extensions and/or conversion to permanent)
Posting Date: 03/31/26
Pay Rate: $60 - $65/hour W2
Notes: Only qualified candidates need apply. On site at least 3 days weekly 8-5
3 Key Consulting is hiring a Senior C&Q Validation Engineer GMP Analytical & Process Equipment for a consulting engagement with our direct client a leading global biopharmaceutical company.
Job Description:
Primarily responsible for leading and/or executing commissioning and qualification activities on new or modified GMP analytical and process equipment utilities and facilities. Responsibilities include generating/reviewing/executing C&Q protocols plans and summary reports. Works with project teams and SMEs to develop testing strategies. Participates in project meetings to inform stakeholders on progress of C&Q activities. Key skills include:
Why is the Position Open
Supplement additional workload on team
Top Must Have Skills:
Day to Day Responsibilities:
Basic Qualifications:
Doctorate degree OR Masters degree and 2 years of experience OR Bachelors degree and 4 years of experience OR Associates degree and 8 years of experience OR High school diploma / GED and 10 years of experience
Red Flags:
Short tenures at previous jobs (-2 years) not local and not willing to relocate
Interview process:
1 video conference interview (Teams) potential follow-up interview
We invite qualified candidates to sendyour resume to. Ifyou decide that youre not interested in pursuing this particular position please feel free to take a look at the other positions on our You are also welcome to sharethis opportunity withanyone you think might be interested in applying for this role.
Location: Thousand Oaks CA. 91320 (Hybrid)
Employment Type: Contract
Business Unit: Engineering Systems
Duration: 1 year (with likely extensions and/or conversion to permanent)
Posting Date: 03/31/26
Pay Rate: $60 - $65/hour W2
Notes: Only qualified candidates need apply. On site at least 3 days weekly 8-5
3 Key Consulting is hiring a Senior C&Q Validation Engineer GMP Analytical & Process Equipment for a consulting engagement with our direct client a leading global biopharmaceutical company.
Job Description:
Primarily responsible for leading and/or executing commissioning and qualification activities on new or modified GMP analytical and process equipment utilities and facilities. Responsibilities include generating/reviewing/executing C&Q protocols plans and summary reports. Works with project teams and SMEs to develop testing strategies. Participates in project meetings to inform stakeholders on progress of C&Q activities. Key skills include:
- Demonstrable experience in a pharmaceutical biotech or life science organization in a C&Q/CQV role.
- Knowledge of cGMP commissioning/qualification/validation practices.
- Familiarity with Kneat Gx Platform or other digital C&Q systems.
- Experience working with cross-functional stakeholders.
- Knowledge of quality assurance principles.
- Experience working within project teams and multiple projects in parallel.
- Effective communication skills both verbal and written.
- Able to think analytically with the ability to resolve issues.
- Able to manage own time efficiently.
Why is the Position Open
Supplement additional workload on team
Top Must Have Skills:
- Experience in commissioning/qualification/validation
- Experience in a GMP environment
- Experience with analytical instruments (Benchtop laboratory equipment)
Day to Day Responsibilities:
- Plan and track implementation of commissioning & qualification actions/documentation versus project(s) timelines.
- Work with project teams to develop the commissioning and qualification strategy and document in qualification plans.
- Generate/evaluate qualification/validation protocols including IQ OQ FT PQ protocols and final reports for new or modified GMP analytical and process equipment utilities and facilities.
- Execute IQ OQ FT PQ protocols which may involve protocol discrepancies investigation and corrective action activities for new or modified GMP analytical and process equipment utilities and facilities.
- Ensure that Qualification/Validation plans are generated and updated for all ongoing projects.
- Prepare evaluate and approve technical and GMP linked documentation such as URS FMEA impact/risk assessment master plans qualification/validation documentation.
- Develop and/or execute FAT/SAT and other commissioning activities for new GMP systems in collaboration with both internal and external partners.
Basic Qualifications:
Doctorate degree OR Masters degree and 2 years of experience OR Bachelors degree and 4 years of experience OR Associates degree and 8 years of experience OR High school diploma / GED and 10 years of experience
Red Flags:
Short tenures at previous jobs (-2 years) not local and not willing to relocate
Interview process:
1 video conference interview (Teams) potential follow-up interview
We invite qualified candidates to sendyour resume to. Ifyou decide that youre not interested in pursuing this particular position please feel free to take a look at the other positions on our You are also welcome to sharethis opportunity withanyone you think might be interested in applying for this role.
Regards
3KC Talent Acquisition Team
Required Experience:
Senior IC
