Jobs in Juncos

We are seeking a C&Q Specialist with expertise in execute qualification activities around an OEM-driven retrofit to an existing GMP manufacturing isolator.Responsibilities: Prepare and maintain all commissioning documentation.Coordinate execution with contractor and vendors.Maintain commissioning st...

EW Specialist QA Job Description: SPECIFIC RESPONSIBILITIES INCLUDE BUT ARE NOT LIMITED TO: Perform On-the-floor Plant Quality Assurance (PQA) review approval and tracking of cGMP processes procedures testing methods in manufacturing documents and records batch record review MES EBR SAP EDMQ DQMS Tr...

. Manufacturing Equipment ownership at CMMS system (Work orders approval closing PM strategy spare parts definition/accuracy/updates) reliability and change control assessments and requirements. Collaborate with Engineering Staff to ensure the best maintenance strategy on manufacturing equipment ope...

In this vital role you will provide technical engineering support to continuous daily operations by performing troubleshooting activities process optimization strategiesupgrades replacements and modifications to the process or equipment in the manufacturing operations.Ensure that all operations are...

Experience working in a GMP-regulated environment within the pharmaceutical medical device or biotechnology industryProficiency in technical report writingEffective communication skills in both Spanish and English (verbal and written)Familiarity with packaging equipment process characterization vali...

We are seeking an Engineer with experience working with packaging equipment process characterization validation monitoring and optimization techniques and Expertise in identifying and managing Corrective and Preventive Actions (CAPAs) in a GMP-regulated environment .Proficiency in technical report w...

We are seeking a Sr. Specialist QA with experience in Commissioning and Qualification Equipment validation QRAES Kneat Good Documentation Practices Change Controls SOPs etcQualifications : Education: Doctorate 2 years of directly related experience or; Masters 4 years of directly related experience...

1. Direct experience providing technical or process-development support to commercial pharmaceutical biotechnology medical-device or combination-product manufacturing operations.2. Experience managing projects3. Experience with sterile injectable products prefilled syringes auto injectors pens or ot...

Preferred qualifications include experience with data analysis dashboard development statistical evaluation GMP documentation validation principles and process improvement. A standout candidate would have working knowledge of AI-enabled or automation tools such as Python Codex Power Automate SQL or...

Facilities and Utilities Commissioning and QualificationComputer System ValidationEquipment validationRisk AssessmentsKNEATCDOCS SCADA TRACKWISEMAXIMOGood Documentation Practices Data IntegrityChange ControlsStandard Operation ProcedureSyringe/Vials Inspection ProcessDocuments revision and approvalS...

We are seeking a Sr. Specialist QA to support Quality Assurance program acts as the technical specialist. Review and approve product MPs.FUNCTIONS- Approve process validation protocols and reports for mfg. processes.- Represent Quality on incident triage team.- Approve Environmental Characterization...

Experience in recipe entry in packaging equipment automation assessment to determine the correct parameter for the recipe and experience in Systech SystemRequirementsMasters degree OR Bachelors degree and 2 years of Engineering experience ORAssociates degree and 6 years of Engineering experience ORH...

We are seeking a Process Engineer with pharma-medical device experience as well as validations life-cycle experience (write/execute/analyze/close) to support the daily operations:Root cause analysisInvestigation experience for QN/CAPAclosuresExperience with manual and automated systems/linesRequirem...

We are seeking Sr. Associate MFG Systems with experience in recipe entry in packaging equipment automation assessment to determine the correct parameter for the recipe and experience in Systech System. RequirementsMaster Degree or Bachelor Degree and 2 years of Engineering experience. Experience in...

To support the installation of several manufacturing solid dosage equipment such as but not limited to:EncapsulatorCheckweigherCompression machineHardness testerEncapsulation machineAuxiliary equipmentMain activities should include:Verification of the equipment installed and configured at the vendor...

Previous experience in change control management project controls and capital projects. Demonstrated experience leading New Product Introduction (NPI) technology transfer process development lifecycle management or commercialization programs. Proven ability to lead complex cross-functional projects...

Strong knowledge and demonstrated experience with Quality Systems particularly deviations CAPA management Change Controls and controlled documentation. Some Experience supporting OEFM electronic forms or similar electronic quality and facilities-management systems preferred. Some understanding of pe...

We are seeking a Senior Project Manager who will lead strategic and highly complex New Product Introduction (NPI) programs. Responsible for developing project strategies governing execution across multiple functions driving organizational alignment managing significant business risks and ensuring su...

We are seeking a Facilities and Engineering Support Specialist to maintaining the integrity and compliance of the manufacturing facility. This role involves providing crucial support in Quality Systems including deviations Corrective and Preventive Actions (CAPAs) Change Controls documentation chang...

We are seeking a Senior Project Manager to lead and manage complex projects ensuring successful execution from initiation through completion. The ideal candidate will possess strong project management expertise and the ability to lead cross-functional teams in a dynamic environment.RequirementsEduca...