Sterile Specialist, Engineering - Rahway

Job summary

This Sterile Specialist position will provide on-site engineering support for sterile operations within Our Company's Research Labs Pharmaceutical Sciences (Pharm Sci), Pharmaceutical Operations Engineering group (Pharm Ops Engineering).
The primary responsibility of this role is to maintain facility, utilities, and manufacturing equipment in accordance with GMP and Safety requirements.
The individual will function as Subject Matter Expert (SME) on validation of equipment used for sterilization and cleaning in clinical drug product manufacturing.
Own author review validation SOPs protocols summary reports perform technical assessments new parts soil matrix coordinate field execution align necessary equipment instruments address issues challenges conceptual approval

• Familiarity with Quality cGMP Safety Environmental Policies Procedures
• Troubleshooting ability mechanical electrical automation
• Maintenance & Engineering techniques management Capital Project management Independent problem-solving SAP Plant Maintenance Gatekeeping Work Order Prioritization eVal Kneat Paperless electronic validation system Experience ProCal Computerized Calibration Maintenance System CCMS Planning Scheduling practices business financial practices Candidate should independently lead facilitate tasks successfully Accountability Adaptability Biopharmaceuticals Capital Projects cGMP Guidelines Electronic Batch Records Emergency Care Equipment Maintenance Ethylene Oxide Sterilizers GMP Compliance Laboratory Experiments Mammalian Cell Culture Orthopedics Periodic Reviews Personal Initiative Pilot Plant Operations Process Engineering Process Optimization Product Formulation Purchase Orders Quality Engineering Reliability Management SAP Plant Maintenance PM Current Employees apply HERE Current Contingent Workers apply HERE US And Puerto Rico Residents Only our company committed inclusion ensuring candidates engage hiring process exhibits true capabilities Please click here need accommodation application hiring process Requirements As Equal Employment Opportunity Employer we provide equal opportunities employees applicants employment prohibit discrimination race color age religion sex sexual orientation gender identity national origin protected veteran status disability status other applicable legally protected characteristics federal contractor comply affirmative action requirements protected veterans individuals disabilities For more information personal rights U.S.EEOC Know Your Rights EEOC GINA Supplement We proud company embraces value bringing talented committed people diverse experiences perspectives skills backgrounds The fastest breakthrough innovation people diverse ideas broad experiences backgrounds skills come together inclusive environment We encourage colleagues respectfully challenge one another thinking approach problems collectively Learn more your rights California Colorado US State Acts U.S. Hybrid Work Model Effective September 5 employees office-based positions U.S.working Hybrid work consisting three total days site Monday Thursday although specific days may vary site organization Friday designated remote-working day unless business critical tasks require on-site presence This Hybrid work model does not apply daily in-person attendance required field-based positions facility-based manufacturing-based research-based positions where work located Company site positions covered collective-bargaining agreement unless agreement provides hybrid work otherwise position reasonably met working remotely Please note Hybrid work model guidance applies roles designated remote The salary range this role $87 137400 This lowest highest salary good faith believe would pay time posting An employee position within salary range based several factors including relevant education qualifications certifications experience skills geographic location government requirements business organizational needs successful candidate eligible annual bonus long-term incentive if applicable We offer comprehensive package benefits Available benefits include medical dental vision healthcare insurance benefits employee family retirement benefits including paid holidays vacation compassionate sick days More information available at You can apply this role via Workday Jobs Hub current employee application deadline stated posting San Francisco Residents Only We consider qualified applicants arrest conviction records employment compliance San Francisco Fair Chance Ordinance Los Angeles Residents Only We consider employment all qualified applicants including those criminal histories manner consistent requirements applicable state local laws City Los Angeles Fair Chance Initiative Hiring Ordinance Search Firm Representatives Please Read Carefully Merck Co Inc Rahway NJ USA known as Merck Sharp Dohme LLC Rahway NJ USA does not accept unsolicited assistance search firms employment opportunities All CVs resumes submitted search firms any employee company valid written search agreement place position deemed sole property company No fee paid candidate hired result agency referral where pre-existing agreement place Where agency agreements place introductions position specific please no phone calls emails Employee Status Regular Relocation No VISA Sponsorship No Travel Requirements No Travel Required Flexible Work Arrangements Not Applicable Shift Day Evening Valid Driving License No Hazardous Material n/a Job Posting End Date January 23 A job posting effective until PM listed job end date ensure you apply day BEFORE job end date Requisition ID R380735

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  Job description

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