Autoclave Performance Qualification Specialist

Juncos, PR
Autónomo
Tiempo completo

Hace 6 días

Our team members are at the heart of everything we do. At Cencora, we are united in our responsibility to create healthier futures, and every person here is essential to us being able to deliver on that purpose. If you want to make a difference at the center of health, come join our innovative company and help us improve the lives of people and animals everywhere. Apply today!Job DetailsSummary of Role:We are seeking a skilled Autoclave Performance Qualification Specialist to join our team. In this role, you will ensure the reliable performance of autoclave systems used in sterilization processes, adhering to GMP, FDA, and ISO standards. You'll conduct performance qualifications (PQ), validations, and troubleshooting to maintain equipment integrity and compliance in our pharmaceutical production environment.Responsibilities:

Design, execute, and document performance qualification protocols for autoclave systems, including cycle development, validation, and re-qualification.
Perform risk assessments, data analysis, and statistical evaluations to verify autoclave efficacy (e.g., heat distribution, penetration, and lethality).
Collaborate with cross-functional teams (Engineering, Validation, and Operations) to resolve equipment issues and implement improvements.
Maintain detailed records, generate reports, and ensure compliance with regulatory requirements (e.g., 21 CFR Part 11, Annex 1).
Train staff on autoclave operations and participate in audits and inspections.
Stay updated on industry best practices and emerging technologies in sterilization validation.

Shift: This position requires availability during execution . The majority of the time the position is AdministrativeLocation: Juncos, PREducation: Bachelor's degree in Engineering, Life Sciences, or a related field (Master's preferred).Preferred Qualifications:

3+ years of experience in pharmaceutical or biotech validation, with a focus on autoclave or sterilization equipment.
Proficiency in validation software (e.g., Kaye Validator, Ellab), statistical tools (e.g., Minitab), and regulatory standards.
Strong analytical skills, attention to detail, and ability to work in a fast-paced, regulated environment.
Certification in validation (e.g., ASQ CQE) or equivalent is a plus.
Excellent communication and teamwork abilities.

This position is for a fixed term contract supporting one of ECHO Consulting Group (A Cencora company) partners on site at their facility.What Cencora offersWe provide compensation, benefits, and resources that enable a highly inclusive culture and support our team members’ ability to live with purpose every day. In addition to traditional offerings like medical, dental, and vision care, we also provide a comprehensive suite of benefits that focus on the physical, emotional, financial, and social aspects of wellness. This encompasses support for working families, which may include backup dependent care, adoption assistance, infertility coverage, family building support, behavioral health solutions, paid parental leave, and paid caregiver leave. To encourage your personal growth, we also offer a variety of training programs, professional development resources, and opportunities to participate in mentorship programs, employee resource groups, volunteer activities, and much more. For details, visitFull timeEqual Employment OpportunityCencora is committed to providing equal employment opportunity without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, age, disability, veteran status or membership in any other class protected by federal, state or local law.The company’s continued success depends on the full and effective utilization of qualified individuals. Therefore, harassment is prohibited and all matters related to recruiting, training, compensation, benefits, promotions and transfers comply with equal opportunity principles and are non-discriminatory.Cencora is committed to providing reasonable accommodations to individuals with disabilities during the employment process which are consistent with legal requirements. If you wish to request an accommodation while seeking employment, please call 888.692.2272 or email . We will make accommodation determinations on a request-by-request basis. Messages and emails regarding anything other than accommodations requests will not be returnedAffiliated Companies Affiliated Companies: Echo Consulting Group Inc

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