Skip navigation
Unable to save this job. Please try again later.


Email this Job to Yourself or a Friend

To begin the application process, please enter your email address.

Company Contact Info

  • Fort Collins, CO

Already have an account?

Sign in to apply with your saved resumes.

New to CareerBuilder?

Don't have an account? Continue as a guest!

Sorry, we cannot save or unsave this job right now.

Report this Job

Trust and Site Security Team.

Don't miss out on new jobs!

Get the latest Validation Engineer (Architecture and Engineering) jobs in Fort Collins, CO delivered directly to your inbox. You can unsubscribe at any time.

Saving Your Job Alert

Job Alert Saved!

Could not save Job Alert!

You have too many Job Alerts!

This email address has reached the maximum of 5 email alerts. To create a new alert, you will need to log into your email and unsubscribe from at least one.

Sign Up

or   Sign In Here
Password Must Contain
8 to 15 characters
1 uppercase letter
1 number or symbol
1 lowercase letter
Create an Account with CareerBuilder to save jobs & unlock these great features
See similar job titles and skills to help you make your next move
Upload a resume and become visible to Hiring Managers and Employers
Compare Salary Information to see where you stand amongst your peers
Easily Quick Apply to jobs with just one click!

Email Send Failed!

Principal Validation Engineer

Apex Systems • Fort Collins, CO

Posted 15 days ago

Job Snapshot

Degree - 4 Year Degree
Other Great Industries
Engineering, Inventory

Job Description

Apex Systems is looking for a Principal Validation Engineer for our client in Northern Colorado. This is a direct hire opportunity with a prominent Pharmaceutical organization in the state. Both local and relocation candidates are welcome to apply. 

Essential Duties & Responsibilities:

  • Assist in the change management for validated processes, FUSE, and CSV.
  • Assist in development and management of Validation Programs/Processes.
  • Generates and maintains site and project Validation Plans.
  • Updates, manages, leads, and executes FUSE, process, and CSV re-qualification schedules/activities.
  • Manages, schedules, and coordinates Validation activities with cross-functional teams.
  • Assists cross-functional teams in FUSE, process, and CSV procurement and requirements.
  • Manages, leads, generates protocols/reports and executes Validation activities for the following FUSE and CSV;
    • GMP Manufacturing Facilities
    • Temperature controlled environments (Warehouse, Stability Chambers, Incubators, Freezers, Water baths, Refrigerators, Hot boxes, etc.)
    • Injectable aseptic manufacturing equipment (Fillers, Wetmill, Bulk Tanks, etc.)
    • Dermatological manufacturing equipment (Mixers, Tanks, Fillers, Homogenizers, etc.)
    • Utilities (WFI, Purified (USP), DI, Clean Steam, etc.)
    • Laboratory equipment (HPLC, TOC, Laminar Flow Hoods, BSC, etc.)
    • Sterilization equipment (Autoclaves, Dry Heat Ovens, Steam in Place (SIP), Isolators, etc.)
    • Cleaning equipment (Clean in Place (CIP), Parts Washer)
    • Laboratory Information Management Systems (LIMS)
    • Electronic Document Management Systems (EDMS)
  • Manages and provides guidance and technical expertise in cycle development initiatives and activities.
  • Manages and provides guidance and technical expertise in cleaning and process development/commercial activities.
  • Collaborates with Management personnel as needed.
  • Participate in audits and follow up on corrective actions.
  • Contribute to the development of departmental budget and monitoring of expenditures.
  • Train, mentor, and supervise junior associates in validation principles.
  • Perform other related duties as assigned.

Knowledge, Skills & Abilities:

  • Effective organization and project management skills.
  • Effective troubleshooting and problem solving skills.
  • Proven skills in managing major Validation projects.
  • Ability to maintain gowning requirements as needed to access controlled areas.
  • Ability to manage multiple projects simultaneously.
  • Ability to work both independently and in conjunction with a team.
  • Develop and implement creative solutions to problems.
  • Proficient knowledge with MS Office.
  • Proficient knowledge of GMP regulations and validation guidelines.
  • Proficient knowledge and experience in writing protocols and following procedures.
  • Experienced with validation tools such as Kaye Validator.
  • Excellent oral and written communication skills demonstrated through interactions internally and externally.
  • A valid driver’s license and acceptable motor vehicle record required.

Education & Experience

  • Bachelor’s degree in Engineering or Science related field. Post Graduate work a plus.
  • Ten or more years’ experience in the pharmaceutical industry, minimum eight years in validation required.
  • Some experience in Statistical Analysis preferred.
  • Demonstrated proficiency in five or more validation areas.
  • In depth knowledge of current validation principles, standard concepts, practices, procedures and requirements in GMP regulated environments.

Working Conditions

  • Working conditions are normal for an office environment.
  • Work may require occasional weekend and/or evening work.
  • Work inside manufacturing clean rooms where gowning is required.
    • Experience in Statistical Analysis.

EEO Employer

Apex is an Equal Employment Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at 844-463-6178

Job ID: 939262
Help us improve CareerBuilder by providing feedback about this job: Report this Job.
For your privacy and protection, when applying to a job online, never give your social security number to a prospective employer, provide credit card or bank account information, or perform any sort of monetary transaction. Learn more.
By applying to a job using CareerBuilder you are agreeing to comply with and be subject to the CareerBuilder Terms and Conditions for use of our website. To use our website, you must agree with the Terms and Conditions and both meet and comply with their provisions.
Don't miss out on new jobs like this
Get the latest jobs delivered to your inbox. Unsubscribe at any time.

Saving Your Job Alert

Job Alert Created

Well, this is embarrassing. We are having trouble saving your search. You can try again or come back at a later time.

Maximum Email Alerts

This email address has reached the maximum of 5 email alerts. To create a new alert, you will need to log into your email and unsubscribe from at least one.

More Jobs at Apex Systems

View All Similar Jobs View All Similar Jobs