{"schemaVersion":"jobsearcher.job.v1","id":"bdffb5dc32b04b6da4f28411","url":"https://jobsearcher.com/jobs/bdffb5dc32b04b6da4f28411","canonicalUrl":"https://jobsearcher.com/jobs/bdffb5dc32b04b6da4f28411","title":"Sr Engineers - HVAC, Packaging & Device Assembling","description":"*Education:*\n\nDoctorate OR -Masters + 2 years of Engineering experience OR -Bachelors in Engineering + 4 years of Engineering experience\n\nRate:\n\n$40-42 W-2, all working hours are paid.\n\n*Attributes (i.e. - preferred qualifications):*\n\n*Position # 1:*\n\n* *Experience in HVAC is required*.\n* Ensure that products are produced and stored according to the defined requirements to obtain the required quality- Process Owner\n* RSO-Ensure that utilities and facilities support the products, production and stored according to the defined requirements to obtain the required quality\n* Ensure the qualification and maintenance of the department, premises, and equipment\n* Ensure the appropriate validations are executed\n* Ensure all GMP or GDP tasks are performed in accordance to procedures by qualified personnel to ensure the equipment / facility , under your responsibility, support the product safety, identity, strength, quality, and purity\n* Complete required training prior to executing GMP or GDP activities\n* Follow established procedures to conduct assigned GMP or GDP activities\n* Follow established requirements for safety, health and hygiene\n* Follow established requirements to access GMP or GDP controlled areas\n* Responsible for management and oversight of GMP activities in assigned Operations function.\n* Ensures that manufacturing facilities, equipment, processes, and procedures are compliant with cGMP requirements and/or other applicable regulations\n* Ensures GMP activities for assigned Operations function follow approved GMP procedures and are documented according to cGMP and/or GDP requirements. May also execute these GMP tasks\n* Responsible for ensuring that risks are identified, assessed, and corrected, to ensure the safety, purity, quality, and effectiveness of the product(s) manufactured\n* Ensures that written procedures describing the instructions to execute GMP activities are controlled, approved, and followed\n* May be required to own or provide subject matter expertise to nonconformance investigations, corrective and preventive actions, change control records or validations\n* Ensures that non-conformances for areas of responsibility are reported promptly to the Quality unit and investigated per procedures\n* Ensures that corrective actions and preventive actions (CAPA) are managed and closed according to procedures\n* Ensures that unplanned ARMS records were investigated, corrected (if applicable ) , managed and closed according to procedures and timely manner.\n* Ensures that planned ARMS records were created, documented, managed and closed according to procedures and timely manner.\n* Completes required assigned training to permit execution of required tasks\n* Ensures the requirements of the Quality Management System are fulfilled\n* Ensure document periodic review activities are completed on time for documents owned by assigned areas of responsibility.\n* Alerts senior manager of significant quality, compliance, supply, and safety risks\n* Provides input for Management Reviews\n* Supports Continual Improvement initiatives, programs, and projects\n* Coordinates in conjunction with other functions activities such as maintenance, shutdowns, systems improvements, repairs, inspections and walkthroughs.\n* Prioritizes and escalates any activity that require immediate attention due to safety or regulatory risk\n* Contract suppliers to request quotes for activities related to your area of responsibility\n* Generate requisitions for activities related to area of responsibility following Quality and Safety requirements\n* Advises on technical strategy, policy and procedure.\n* Creates technical documentation to agreed standards.\n* Complete zone inspection activities as required\n* Support and be a liaison for Capital projects for project execution under your area of responsibility. Overseen the project execution and the results that comply with the Amgen standards.\n* Be agile to apply short term and long-term solutions implementations.\n* Support, prioritize and provide feedback to the GLAM (obsolete equipment replacement) program.\n* Support the EHSS permits program and its trainings.\n* Support and be a liaison for all request form clients.\n\n*Position # 2:*\n\nExperience in Commissioning and Qualification of parenteral products, vision system, device assembly and packaging (Automatic and HMLV lines).\n\n*Position # 3:*\n\n* General packaging/engineering experience in final product manufacturing within the Pharma/Biotech Industry.\n* Excellent understanding of Good Manufacturing Practices (GMP) and Good Documentation Practices (GDP).\n* Strong knowledge of common materials used in pharmaceutical primary and secondary packaging (bottles, labels, trays, lidding material, leaflets, paperboard, sterile barrier packaging, corrugate, etc.).\n* Familiar with distribution testing per ASTM D4169 and ASTM, ISO, TAPPI, USP and EP testing standards.\n* Strong interpersonal, project management, technical problem solving and communication (written and verbal) skills.\n* Ability to work in teams and adapt to a continuously evolving environment.\n* Ability and experience writing test protocols, performing technical evaluations and testing to support reports used to uphold the use of selected materials and packaging components.\n\nPay: $40.00 - $42.00 per hour\n\nWork Location: In person","company":"Cmmvalidation","rawCompany":"cmmvalidation","city":"Juncos","state":"PR","isRemote":false,"isActive":false,"createdAt":"2026-10-06T17:41:00.775Z","occupations":[{"code":"11-3051.01","title":"Quality Control Systems Managers","slug":"quality-control-systems-managers"},{"code":"17-2112.02","title":"Validation Engineers","slug":"validation-engineers"},{"code":"19-4099.01","title":"Quality Control Analysts","slug":"quality-control-analysts"}],"industries":[{"code":"325412","title":"Pharmaceutical Preparation Manufacturing","slug":"pharmaceutical-preparation-manufacturing"},{"code":"333415","title":"Air-Conditioning and Warm Air Heating Equipment and Commercial and Industrial Refrigeration Equipment Manufacturing","slug":"air-conditioning-and-warm-air-heating-equipment-and-commercial-and-industrial-refrigeration-equipment-manufacturing"},{"code":"334510","title":"Electromedical and Electrotherapeutic Apparatus Manufacturing","slug":"electromedical-and-electrotherapeutic-apparatus-manufacturing"}],"jobPosting":{"@context":"https://schema.org","@type":"JobPosting","title":"Sr Engineers - HVAC, Packaging & Device Assembling","description":"*Education:*\n\nDoctorate OR -Masters + 2 years of Engineering experience OR -Bachelors in Engineering + 4 years of Engineering experience\n\nRate:\n\n$40-42 W-2, all working hours are paid.\n\n*Attributes (i.e. - preferred qualifications):*\n\n*Position # 1:*\n\n* *Experience in HVAC is required*.\n* Ensure that products are produced and stored according to the defined requirements to obtain the required quality- Process Owner\n* RSO-Ensure that utilities and facilities support the products, production and stored according to the defined requirements to obtain the required quality\n* Ensure the qualification and maintenance of the department, premises, and equipment\n* Ensure the appropriate validations are executed\n* Ensure all GMP or GDP tasks are performed in accordance to procedures by qualified personnel to ensure the equipment / facility , under your responsibility, support the product safety, identity, strength, quality, and purity\n* Complete required training prior to executing GMP or GDP activities\n* Follow established procedures to conduct assigned GMP or GDP activities\n* Follow established requirements for safety, health and hygiene\n* Follow established requirements to access GMP or GDP controlled areas\n* Responsible for management and oversight of GMP activities in assigned Operations function.\n* Ensures that manufacturing facilities, equipment, processes, and procedures are compliant with cGMP requirements and/or other applicable regulations\n* Ensures GMP activities for assigned Operations function follow approved GMP procedures and are documented according to cGMP and/or GDP requirements. May also execute these GMP tasks\n* Responsible for ensuring that risks are identified, assessed, and corrected, to ensure the safety, purity, quality, and effectiveness of the product(s) manufactured\n* Ensures that written procedures describing the instructions to execute GMP activities are controlled, approved, and followed\n* May be required to own or provide subject matter expertise to nonconformance investigations, corrective and preventive actions, change control records or validations\n* Ensures that non-conformances for areas of responsibility are reported promptly to the Quality unit and investigated per procedures\n* Ensures that corrective actions and preventive actions (CAPA) are managed and closed according to procedures\n* Ensures that unplanned ARMS records were investigated, corrected (if applicable ) , managed and closed according to procedures and timely manner.\n* Ensures that planned ARMS records were created, documented, managed and closed according to procedures and timely manner.\n* Completes required assigned training to permit execution of required tasks\n* Ensures the requirements of the Quality Management System are fulfilled\n* Ensure document periodic review activities are completed on time for documents owned by assigned areas of responsibility.\n* Alerts senior manager of significant quality, compliance, supply, and safety risks\n* Provides input for Management Reviews\n* Supports Continual Improvement initiatives, programs, and projects\n* Coordinates in conjunction with other functions activities such as maintenance, shutdowns, systems improvements, repairs, inspections and walkthroughs.\n* Prioritizes and escalates any activity that require immediate attention due to safety or regulatory risk\n* Contract suppliers to request quotes for activities related to your area of responsibility\n* Generate requisitions for activities related to area of responsibility following Quality and Safety requirements\n* Advises on technical strategy, policy and procedure.\n* Creates technical documentation to agreed standards.\n* Complete zone inspection activities as required\n* Support and be a liaison for Capital projects for project execution under your area of responsibility. Overseen the project execution and the results that comply with the Amgen standards.\n* Be agile to apply short term and long-term solutions implementations.\n* Support, prioritize and provide feedback to the GLAM (obsolete equipment replacement) program.\n* Support the EHSS permits program and its trainings.\n* Support and be a liaison for all request form clients.\n\n*Position # 2:*\n\nExperience in Commissioning and Qualification of parenteral products, vision system, device assembly and packaging (Automatic and HMLV lines).\n\n*Position # 3:*\n\n* General packaging/engineering experience in final product manufacturing within the Pharma/Biotech Industry.\n* Excellent understanding of Good Manufacturing Practices (GMP) and Good Documentation Practices (GDP).\n* Strong knowledge of common materials used in pharmaceutical primary and secondary packaging (bottles, labels, trays, lidding material, leaflets, paperboard, sterile barrier packaging, corrugate, etc.).\n* Familiar with distribution testing per ASTM D4169 and ASTM, ISO, TAPPI, USP and EP testing standards.\n* Strong interpersonal, project management, technical problem solving and communication (written and verbal) skills.\n* Ability to work in teams and adapt to a continuously evolving environment.\n* Ability and experience writing test protocols, performing technical evaluations and testing to support reports used to uphold the use of selected materials and packaging components.\n\nPay: $40.00 - $42.00 per hour\n\nWork Location: In person","datePosted":"2026-10-06T17:41:00.775Z","dateModified":"2026-10-06T17:41:00.775Z","hiringOrganization":{"@type":"Organization","name":"Cmmvalidation","sameAs":"https://jobsearcher.com"},"jobLocation":{"@type":"Place","address":{"@type":"PostalAddress","addressLocality":"Juncos","addressRegion":"PR","addressCountry":"US"}},"identifier":{"@type":"PropertyValue","name":"JobSearcher","value":"bdffb5dc32b04b6da4f28411"},"url":"https://jobsearcher.com/jobs/bdffb5dc32b04b6da4f28411"}}