Validation Engineer

PSCBiotech provides the life sciences with essential services toensure that health care products are developed manufactured anddistributed to the highest standards in compliance with allapplicable regulatory requirements.

Ourgoal is to skyrocket our clients success and you can be a part ofour team s achievements. Employing a global team of skilledprofessionals and experts that span across strategically locatedoffices in North America Europe Asia and the Middle East we areproud of the roles we have fulfilled to help our clients achievesuccess.

TheExperience

Withoperations spanning the globe and featuring a multicultural teamPSC Biotech is passionate about bringing the best and brightesttogether in an effort to form something truly special.

When youmake the decision to join our team you will be offered the abilityto feel inspired in your career explore your professional passionsand work alongside a group of people who will value and nurtureyourtalents.

Weare firm believers in coaching and developing the next generationof industry leaders and influencers. As such you will not only beoffered compensation and benefits structure that rewards you butalso be provided with the tools that will help you grow andlearn.

AtPSC Biotech it s about more than just a job it s about your careerand yourfuture.

YourRole

Weare hiring an experienced Validation Engineer to support multiplecommissioning qualification and validation projects.

• Developand execute IQ OQ PQ and PV protocols test methods proceduresreports risk assessments and so on for a range of pharmaceuticaland manufacturing equipment facilities utilities and associatedsystems.
• Contributeto the development of master plans and validation strategies for avariety of manufacturing processes adhering to regulatoryrequirements and compliance.
• Collaboratewith cross functional teams to ensure alignment and successfulcompletion of validation activities and deliverables.
• Performrisk assessments and support risk mitigation strategies.Investigate review and efficiently closedeviations.
• Providesupport for regulatory inspections as needed.
• Identifypotential risks / issues throughout validation lifecycle effectivelysupporting change controls.
• Conductperiodic reviews and requalification assessments as needed.
• Ensureall required documentation is reviewed approved stored and managedaccurately.
• Collaboratewith vendors and contractors to ensure that equipment and systemsmeet validation requirements andspecifications.
• Drivecontinuous improvement initiatives to enhance validation processesdocumentation practices and compliance standards across theorganization.
• Additionalresponsibilities as required to drive successful projectcompletion.

Requirements

• Bachelorsdegree in relevant engineering discipline.
• 5years in a equipment commissioning qualification and validationengineering role including proven success developing and executingvalidation protocols in the pharmaceutical manufacturing industry.
• Indepthknowledge of regulatory requirements and guidelines including cGMPFDA etc.
• Experiencedwith validation of pharmaceutical manufacturing equipmentfacilities utilities and computerizedsystems.
• Advancedunderstanding of validation principles and methodologies.
• Excellenttechnical writing skills. 5 years of experience drafting developingreviewing and authoring technical documentation including protocolsprocedures risk assessment specification requirements etc.
• Strongunderstanding of engineering specifications (URS DS FS etc.)
• Detailorientedwith a focus on accuracy and compliance.
• Abilityto manage multiple priorities and prioritize tasks effectively.
• Excellentcommunication and interpersonal skills.
• Stronganalytical skills with the ability to problemsolve and troubleshooteffectively.
• AtPSC Biotech many of our projects and clients are located in variousregions around the country. Therefore we value candidates who arewilling and able to travel as needed for project assignments andclient engagements.

The ability to adapt to different locationscultures and work environments is essential as it allows our teammembers to collaborate effectively with clients and colleaguesnationally.

EqualOpportunity Employment Statement :

PSCis committed to is committed to a policy of Equal EmploymentOpportunity with respect to all employees interns and applicantsfor employment.

Consistent with this commitment our policy is tocomply with all applicable federal state and local laws concerningemployment discrimination.

Accordingly the Company prohibitsdiscrimination against qualified employees interns and applicantsin all aspects of employment including but not limited to : recruitment interviewing hiring (or failure or refusal to hire)evaluation compensation promotion job assignment transfer demotiontraining leaves of absence layoff benefits use of facilitiesworking conditions termination and employersponsored activities andprograms including wellness social and recreational programs.

Employment decisions will be made without regard to an applicant semployee 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 orany other status protected bylaw.

LIRW1

Bachelor's degree in relevant engineering discipline. 5+ years in aequipment commissioning, qualification, and validation engineeringrole, including proven success developing and executing validationprotocols in the pharmaceutical manufacturing industry.

In-depthknowledge of regulatory requirements and guidelines, includingcGMP, FDA, etc. Experienced with validation of pharmaceuticalmanufacturing equipment, facilities, utilities, and computerizedsystems.

Advanced understanding of validation principles andmethodologies. Excellent technical writing skills. 5+ years ofexperience drafting, developing, reviewing, and authoring technicaldocumentation including protocols, procedures, risk assessment,specification requirements, etc.

Strong understanding ofengineering specifications (URS, DS, FS, etc.) Detail-oriented witha focus on accuracy and compliance.

Ability to manage multiplepriorities and prioritize tasks effectively. Excellentcommunication and interpersonal skills. Strong analytical skillswith the ability to problem-solve and troubleshoot effectively.

AtPSC Biotech, many of our projects and clients are located invarious regions around the country. Therefore, we value candidateswho are willing and able to travel as needed for projectassignments and client engagements.

The ability to adapt todifferent locations, cultures, and work environments is essential,as it allows our team members to collaborate effectively withclients and colleagues nationally.

Equal Opportunity EmploymentStatement : PSC is committed to is committed to a policy of EqualEmployment Opportunity with respect to all employees, interns, andapplicants for employment.

Consistent with this commitment, ourpolicy is to comply with all applicable federal, state and locallaws concerning employment discrimination.

Accordingly, the Companyprohibits discrimination against qualified employees, interns andapplicants in all aspects of employment including, but not limitedto : recruitment, interviewing, hiring (or failure or refusal tohire), evaluation, compensation, promotion, job assignment,transfer, demotion, training, leaves of absence, layoff, benefits,use of facilities, working conditions, termination andemployer-sponsored activities and programs, including wellness,social and recreational programs.

Employment decisions will be madewithout regard to an applicant s, employee s, or intern s actual orperceived : race, color, religion, sex (including pregnancy, genderidentity, and sexual orientation), national origin, age (40 orolder), disability, genetic information, or any other statusprotected by law. #LI-RW1