Validation Engineer

3 weeks ago


Rockville, Maryland, United States PSC Biotech Full time
Job Title: Validation Engineer

About the Role:
PSC Biotech is seeking an experienced Validation Engineer to support multiple commissioning, qualification, and validation projects. As a key member of our team, you will be responsible for developing and executing IQ, OQ, PQ, and PV protocols, test methods, procedures, reports, risk assessments, and so on for a range of pharmaceutical and manufacturing equipment, facilities, utilities, and associated systems.

Key Responsibilities:

* Develop and execute validation protocols for pharmaceutical manufacturing equipment, facilities, utilities, and associated systems
* Collaborate with cross-functional teams to ensure alignment and successful completion of validation activities and deliverables
* Perform risk assessments and support risk mitigation strategies
* Investigate, review, and efficiently close deviations
* Provide support for regulatory inspections as needed
* Identify potential risks/issues throughout validation lifecycle, effectively supporting change controls

Requirements:

* Bachelor's degree in a relevant engineering discipline
* 5+ years of experience in a commissioning, qualification, and validation engineering role, including proven success developing and executing validation protocols in the pharmaceutical manufacturing industry
* In-depth knowledge of regulatory requirements and guidelines, including cGMP, FDA, etc.
* Experienced with validation of pharmaceutical manufacturing equipment, facilities, utilities, and computerized systems
* Advanced understanding of validation principles and methodologies
* Excellent technical writing skills
* Strong understanding of engineering specifications (URS, DS, FS, etc.)
* Detail-oriented with a focus on accuracy and compliance
* Ability to manage multiple priorities and prioritize tasks effectively
* Excellent communication and interpersonal skills
* Strong analytical skills with the ability to problem-solve and troubleshoot effectively

About PSC Biotech:
PSC Biotech is a global life sciences company that provides essential services to ensure that healthcare products are developed, manufactured, and distributed to the highest standards, in compliance with all applicable regulatory requirements. Our goal is to support our clients' success, and you can be a part of our team's achievements.

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