oracle
Validation Engineer IV
Albany Molecular Research, Inc.
Albuquerque, USA
Full-time
Senior · 30+ years experience
Onsite
Discovered 1 weeks ago
Full Job Posting
Education and Experience
- Bachelor’s degree in science, Engineering, or relevant field with a minimum of eight (8) years relevant experience of pharmaceutical validation in an aseptic/sterile product environment
- OR
- Master’s degree in science, Engineering, or relevant field with six (6) years relevant experience of pharmaceutical validation in an aseptic/sterile product environment
- Experience with validation tools and processes, including temperature mapping and use of Kaye Validator / Ellab Loggers etc.
- Experience with FDA and EU regulations for pharmaceuticals and validation requirements, preferred
- Knowledge of regulatory requirements, including FDA regulations, ISO 9000-3, PIC/S guidelines for cGMP, and GAMP 4 and 5 based on the GAMP V-Model Framework, as well as EU GMP Annex 11 for computer systems compliance
- Supervisory Responsibilities:
- This role does not have supervisory responsibilities, yet it may involve mentoring, guiding, and advising.
- Other Skills and Abilities:
- Provides guidance and mentorship to team members
- Fosters a collaborative and positive work environment
- Champions change
- Promotes a safe and healthy work environment by actively identifying and addressing potential hazards, following established safety protocols, participating in safety training programs, and fostering a culture of awareness and responsibility among team members.
- Demonstrates strong attention to detail
- Proficiency in advanced mathematics (e.g., calculus) and technical writing
- Other Qualifications:
- Must pass a background check
- Must pass a drug screen
- May be required to pass Occupational Health Screening
- Must obtain and maintain gowning certification
- May be required to obtain and maintain media qualification
- May be required to wear a respirator
- Education, experience, location and tenure may be considered along with internal equity when job offers are extended.
- We do not accept unsolicited assistance from any headhunters or recruitment firms for any of our job openings. All resumes or profiles submitted by search firms to any employee at Curia, in any form without a valid, signed search agreement by an authorized signatory in place for the specific position, approved by Talent Acquisition, will be deemed the sole property of Curia. No fee will be paid in the event the candidate is hired by Curia because of the unsolicited referral.
- All interested applicants must apply online. Please be aware of scammers. Curia will only send offer letters and requests for sensitive personal information from a curiaglobal.com email address. Curia is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability. Curia is an E-Verify employer.
Preferred Qualifications
- Experience with FDA and EU regulations for pharmaceuticals and validation requirements, preferred
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