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Company Contact Info
- Fort Collins, CO
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Principal Validation Engineer
Apex Systems • Fort Collins, CO
Posted 15 days ago
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 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.
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