Commissioning Qualification Validation Engineer
vor 1 Monat
Job Description
PSC Biotech provides the life sciences with essential services to ensure that health care products are developed, manufactured, and distributed to the highest standards, in compliance with all applicable regulatory requirements. Our goal is to skyrocket our clients' success, and you can be a part of our team's achievements. Employing a global team of skilled professionals and experts that span across strategically located offices in North America, Europe, Asia-Pacific and the Middle East, we are proud of the roles we have fulfilled to help our clients achieve success.
Your Role
We are looking for a Commissioning, Qualification, and Validation (CQV) Engineer. The CQV Professional would work alongside a talented PSC Biotech Team in an exciting, developing, and diverse biotechnology landscape. Responsibilities include:
Commission, qualify, and validate GxP facilities, equipment, and utilities in assigned projects.
Responsible for protocol writing and execution - Draft, execute, review, and approve validation documentation ensuring the documentation meets cGMP requirements, regulatory requirements, and quality standards.
Draft and execute validation documentation such as:
Validation Project & Master Plans
Requirement Specifications (URS, DS, FS)
IQ and OQ Test Scripts
IQ/OQ/PQ Protocols
Validation Summary Report
Initiate and coordinate risk analyses, design reviews, and execute FAT/SAT, IQ, OQ, and PQ.
Conduct preventative maintenance and perform risk assessments.
Recommend process improvements where needed ensuring compliance with industry standards.
Establish validation standards and develop performance testing and quality control measures.
Execute process equipment and clean room validation.
Clearly communicate all progress, updates, and action steps for assigned projects.
Collaborate with multiple departments on assigned project activities and deliverables.
Additional duties as assigned.
Requirements
Bachelor's Degree in a relevant science or engineering field, or equivalent years of hands-on experience.
3+ years' experience in the biotechnology and pharmaceutical industries with a minimum of 2 years relevant experience performing CQV activities within GMP environment.
Sound industry knowledge, project proficiency, and autonomy expected.
Experienced in CQV of facility/utility/equipment, including PW, HVAC and process or laboratory equipment, etc.
Understands current risk-based validation approaches.
Experience in authoring, revising, reviewing, and completing controlled documents for validation projects.
Experience with system impact assessment and risk assessment.
Good knowledge of the code of GMP and PIC/S code.
Previous experience in the Life Sciences Industry is required.
Previous experience in GxP Industries are required.
Must be adaptable, customer service oriented, and have a positive attitude.
Excellent organizational skills.
High attention to detail.
Must have strong written and verbal communication skills.
Benefits
Equal Opportunity Employment Statement: PSC is committed to a policy of Equal Employment Opportunity with respect to all employees, interns, and applicants for employment. Consistent with this commitment, our policy is to comply with all applicable federal, state and local laws concerning employment discrimination. Accordingly, the Company prohibits discrimination against qualified employees, interns and applicants in all aspects of employment including, but not limited to: recruitment, interviewing, hiring (or failure or refusal to hire), evaluation, compensation, promotion, job assignment, transfer, demotion, training, leaves of absence, layoff, benefits, use of facilities, working conditions, termination and employer-sponsored activities and programs, including wellness, social and recreational programs. Employment decisions will be made without regard to an applicant's, employee's, or intern's actual or perceived: race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), national origin, age (40 or older), disability, genetic information, or any other status protected by law.
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