Thisrole is 100% onsite at the Easton OH location. The role requiresstrong validation skills and experience as well as strong peopleand communication skills.
The position will support multipleprojects across all of the Pharma Client facilities and ensurevalidation deliverables are met.
This will require understandingproject schedules validation deliverables and knowledge of currentvalidation standards. Resource must be independent and willing towork with multipleSMEs.
- Authoringediting and executing technical commissioning qualification andvalidation documentation for standard equipment / systems / softwareand processes
- Runningtest scripts and documentingresults
- Adherencewith project schedule for all assignedactivities
- Maintainingclear detailed records qualification andvalidation
- Documentingimpact and risk assessments as part of ateam
- Completinguser interface testing software verification and complete alarmtesting on automatedsystems
- Developingreviewing and executing testingdocumentation
- Makingrecommendations for design or process modification based on testresults when executing testscripts
- Generalunderstanding of capital equipment implementation and processknowledge
- Understandingvalidation documents URS IQ OQPQ
Requirements
- Minimum12 years of Work Experience
- Expertisein Production Equipment Facilities (Clean Room Qualification withEMPQ) and Utilities (WFI HVAC Compressed Gases) for the followingdeliverables :
- ReviewingFactory Acceptance Testing (FAT)documentation.
- Reviewingand updating URS System Level Impact Assessments (SLIA) and SystemClassification Assessments (SCA).
- AuthoringValidation Project Plans.
- AuthoringRequirements Traceability Matrix(RTM)
- Executionsupport of the followingdocuments :
- ReceiptVerification (RV)
- SiteAcceptance Testing (SAT)protocols.
- CommissioningProtocols (IVOV)
- Drafting and Executing Data Integrity (DI)Assessment
- Experiencein GMP regulatedEnvironment
Benefits
Highgrowth potential and fastpaced organization with a peoplefocusedculture
Competitivepay plus performancebased incentiveprograms
CompanypaidLife ShortTerm and LongTerm DisabilityInsurance.
MedicalDental & Visioninsurances
FSADCARE CommuterBenefits
SupplementalLife Hospital Critical Illness and LegalInsurance
HealthSavingsAccount
401(k)Retirement Plan (Employer Matchingbenefit)
PaidTime Off (Rollover Option) andHolidays
AsNeeded SickTime
TuitionReimbursement
TeamSocial Activities (We havefun!)
EmployeeRecognition
EmployeeReferralProgram
PaidParental Leave andBereavement
Expertise in Production Equipment, Facilities (Clean RoomQualification with EMPQ), and Utilities (WFI, HVAC, CompressedGases) for the following deliverables : Reviewing Factory AcceptanceTesting (FAT) documentation.
Reviewing and updating URS, SystemLevel Impact Assessments (SLIA), and System ClassificationAssessments (SCA). Authoring Validation Project Plans.
AuthoringRequirements Traceability Matrix (RTM) Execution support of thefollowing documents : Receipt Verification (RV) Site AcceptanceTesting (SAT) protocols.
Commissioning Protocols (IV, OV) Draftingand Executing Data Integrity (DI) Assessment Experience in GMPregulated Environment
Lead CQV Engineer
Thisrole is 100% onsite at the Easton OH location.The role requiresstrong validation skills and experience as well as strong peopleand communication skills.The position will support multipleprojects across all of the Pharma Client facilities and ensurevalidation deliverables are met.Resource must be...
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