3 Key Consulting, Inc.

Senior C&Q Validation Engineer – GMP Analytical & Process Equipment- (JP15147)

3 Key Consulting, Inc.  •  $60 - $70/hr  •  Thousand Oaks, CA (Hybrid)  •  2 months ago
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Job Description

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 - $70/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.


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 send your resume to  resumes@3keyconsulting.com  If you decide that you’re not interested in pursuing this particular position, please feel free to take a look at the other positions on our website www.3keyconsulting.com/careers. You are also welcome to share this opportunity with anyone you think might be interested in applying for this role.
3 Key Consulting, Inc.

About 3 Key Consulting, Inc.

3Key Consulting specializes in the rapid recruitment and placement of business and IT professional within the life sciences and healthcare industries. With 12 years of experience, 3Key has established a vast network of industry professionals and forged strong partnerships/alliances with key academic institutions across the country to continually develop our business professional and niche skill pipeline.

3KC offers a full suite of staffing solutions including PEO and compliance services. 3KC has several technology and industry domain practices including competencies in business intelligence, healthcare and life sciences.

People, process, and technology are 3 key areas of focus that we carefully examine individually and jointly, in order to deliver on our client's 3 key areas of focus - better, faster and cost effective BI and staffing solutions.

MISSION:

To create a better work experience for our customers, partners and employees through exceptional dedication and performance.

• We make hiring easier

• We build strong teams

• We bring about positive outcomes

VISION:

3 Key Consulting’s responsibility is to continually improve the manner and efficiency in which human resources and businesses are brought together to create value. Our vision is to put programs into action that improve market efficiencies while helping businesses and people be more productive.

Industry
Unknown
Company Size
1-10 employees
Headquarters
Simi Valley, CA
Year Founded
2009
Website
3keyconsulting.com
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