Commissioning Qualification Validation Engineer

Commissioning Qualification Validation EngineerJoin to apply for the Commissioning Qualification Validation Engineer role at PSC Biotech CorporationCommissioning Qualification Validation Engineer1 day ago Be among the first 25 applicantsJoin to apply for the Commissioning Qualification Validation Engineer role at PSC Biotech CorporationGet AI-powered advice on this job and more exclusive features.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.The ExperienceWith operations spanning the globe and featuring a multi-cultural team, PSC Biotech is passionate about bringing the best and brightest together in an effort to form something truly special.
When you make the decision to join our team, you will be offered the ability to feel inspired in your career, explore your professional passions, and work alongside a group of people who will value and nurture your talents.We are firm believers in coaching and developing the next generation of industry leaders and influencers.
As such, you will not only be offered compensation and benefits structure that rewards you, but also be provided with the tools that will help you grow and learn.At PSC Biotech, it's about more than just a job—it's about your career and your future.Your RoleWe 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.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 PlansRequirement Specifications (URS, DS, FS)IQ and OQ Test ScriptsIQ/OQ/PQ ProtocolsValidation Summary ReportInitiate and coordinate risk analyses, design reviews, and execute FAT/SAT, IQ, OQ, and PQ.Conduct preventative maintenance and perform risk assessments.Recommended 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.RequirementsBachelor'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, have a positive attitude.Excellent organizational skills.High attention to detail.Must have strong written and verbal communication skills.BenefitsEqual Opportunity Employment Statement:PSC is committed to 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.Seniority levelSeniority levelMid-Senior levelEmployment typeEmployment typeFull-timeJob functionJob functionQuality AssuranceReferrals increase your chances of interviewing at PSC Biotech Corporation by 2xSign in to set job alerts for "Validation Engineer" roles.North Sydney, New South Wales, Australia 1 day agoSydney Olympic Park, New South Wales, Australia 2 weeks agoHigh Voltage Electrical Testing Technician High Voltage Electrical Testing Technician - SydneySydney, New South Wales, Australia 2 weeks agoSydney, New South Wales, Australia 4 days agoSydney, New South Wales, Australia 3 months agoSydney, New South Wales, Australia 7 hours agoSydney, New South Wales, Australia 2 days agoSydney, New South Wales, Australia 3 weeks agoGraduate Electrical Engineer - Buildings - SydneyElectrical Engineers - Intermediate, Senior & Lead roles - Defence & MaritimeSydney, New South Wales, Australia 2 weeks agoSydney, New South Wales, Australia 3 weeks agoNorth Sydney, New South Wales, Australia 1 day agoSydney, New South Wales, Australia 2 weeks agoSydney, New South Wales, Australia 2 months agoSydney, New South Wales, Australia 11 hours agoRenewable Energy Project Engineer - Octopus AustraliaSydney, New South Wales, Australia 4 days agoSydney, New South Wales, Australia 3 weeks agoParramatta, New South Wales, Australia 1 week agoSydney, New South Wales, Australia 2 weeks agoSydney, New South Wales, Australia 2 weeks agoIngleburn, New South Wales, Australia 2 months agoSydney, New South Wales, Australia 3 weeks agoSydney, New South Wales, Australia 10 hours agoSydney, New South Wales, Australia 3 weeks agoSydney, New South Wales, Australia 8 hours agoSydney, New South Wales, Australia 2 weeks agoMacquarie Park, New South Wales, Australia 1 month agoWe're unlocking community knowledge in a new way.
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