CQV Engineer

Job Description
PSC Biotech providesthelife sciences with essential services to ensure thathealth careproducts are developed, manufactured, anddistributed to thehighest standards, in compliance with allapplicable regulatoryrequirements.

Our goal is toskyrocketour clients' success, and you can be a part of ourteam'sachievements. Employing a global team of skilledprofessionals andexperts that span across strategicallylocated offices in NorthAmerica, Europe, Asia and the MiddleEast, we are proud of theroles we have fulfilled to help ourclients achieve success.

TheExperience

With operationsspanningthe globe and featuring a multi-cultural team, PSCBiotech® ispassionate about bringing the best and brightesttogether in aneffort to form something truly special. Whenyou make the decisionto join our team, you will be offeredthe ability to feel inspiredin your career, explore yourprofessional passions, and workalongside a group of peoplewho will value and nurture your talents.

We are firm believersincoaching and developing the next generation of industryleadersand influencers. As such, you will not only beofferedcompensation and benefits structure that rewards you,but also beprovided with the tools that will help you growand learn.

At PSC Biotech®, it'sabout more than just a job-it's about your career and yourfuture.

Your Role

We are hiringexperiencedvalidation engineers responsible for thecommissioning,qualification, and validation for facilities,utilities, andequipment in the pharmaceutical and biotechindustries. Ourengineers play a critical role in drivingproject success, whilesupporting validation planning,development, documentation, andexecution, and ensuringregulatory standards and qualityrequirements are met.

• Develop and executecommissioning, qualification, and validation protocols forrequired production scale process equipment and systems including Mix Vessels, Cents, Filter Presses, etc.
• Prepare andmaintaincomprehensive documentation, includingvalidation protocols, plans, reports, and standardoperating procedures.
• Identify and assessrisks associated with CQV activities and develop effectivemitigation strategies.
• Troubleshoot andresolve issues related to equipment and processperformance.
• Collaborative withcross-functional teams to ensure alignment on CQV activitiesand project timelines.
• Ensure compliancewith regulatory requirements (FDA, EMA, etc.) and industrystandards (GMP, GAMP, etc.).
• Additionalresponsibilities as required to drive successful validationproject deliverables.

Requirements

• Bachelor's degreeinEngineering, Life Sciences, or a related field.
• 2-7 years ofequipment commissioning, qualification, and validationengineering experience in the pharmaceutical and/or biotechindustries.
• Strong knowledge ofregulatory requirements and industry standards.
• Experience withvalidation lifecycle management and risk-basedapproaches.
• Excellentanalyticaland technical problem solvingskills.
• Strong technicalwriting skills and understanding of full lifecycledocumentation (protocols, reports, procedures, riskassessments, specifications and requirements, etc.)
• Effectivecommunication and interpersonal skills.
• Proactive withstrongorganization, time management, and projectmanagement abilities.
• Excellent attentionto detail with commitment to quality and compliance.
• Flexibility to work evenings and weekends when required.
• At PSC Biotech,manyof our projects and clients are located invarious regionsaround the country. Therefore, wevalue candidates who arewilling and able to travelas needed for project assignmentsand clientengagements. The ability to adapt to differentlocations, cultures, and work environments are essential, asitallows our team members to collaborateeffectively withclients and colleagues nationally.
• Must be authorized towork in the US.
• No C2C at this time.

Benefits

Offering a full suiteofbenefits, PSC Biotech™ is firmly focused on diligentlyinvestingin our employees who enable our company to fulfillour mission andachieve success. We want to promote balance,so you not only enjoyyour work, but also have the time andresources to live your lifehappy and healthy.

• Medical, Dental,andVision - PSC pays 100% of all qualifying employeemedicalpremiums and 50% for qualifyingdependents
• Insurance optionsforEmployee Assistance Programs, Basic LifeInsurance, LongTerm Disability andmore.
• 401(k) and 401(k)matching
• PTO, Sick Time, andPaid Holidays
• EducationAssistance
• PetInsurance
• Discounted rate atAnytime Fitness
• Financial Perks andDiscounts

Adhering to the requirements of California's law on salary transparency, the salary bracket for this role is set between $85,000 - $100,000 annually. The salary offered may be adjusted based on various factors such as the applicant's qualifications, skills, and professional experience.

Equal OpportunityEmployment Statement

PSC Biotech is committed to a policy of Equal Employment Opportunity with respectto all employees, interns, and applicants for employment.Consistent with this commitment, our policy is to comply with allapplicable federal, state and local laws concerning employmentdiscrimination. Accordingly, the Company prohibits discriminationagainst qualified employees, interns and applicants in all aspectsof 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 activitiesand programs,including wellness, social and recreationalprograms. Employment decisions will be made without regard to anapplicant's, employee's, or intern's actual or perceived: race,color, religion, sex (including pregnancy, gender identity, andsexual orientation), national origin, age (40 or older),disability, genetic information, or any other status protected bylaw.

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