Sr Engineers - HVAC, Packaging & Device Assembling

*Education:* Doctorate OR -Masters + 2 years of Engineering experience OR -Bachelors in Engineering + 4 years of Engineering experience Rate: $40-42 W-2, all working hours are paid. *Attributes (i.e. - preferred qualifications):* *Position # 1:* * *Experience in HVAC is required*. * Ensure that products are produced and stored according to the defined requirements to obtain the required quality- Process Owner * RSO-Ensure that utilities and facilities support the products, production and stored according to the defined requirements to obtain the required quality * Ensure the qualification and maintenance of the department, premises, and equipment * Ensure the appropriate validations are executed * 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 * Complete required training prior to executing GMP or GDP activities * Follow established procedures to conduct assigned GMP or GDP activities * Follow established requirements for safety, health and hygiene * Follow established requirements to access GMP or GDP controlled areas * Responsible for management and oversight of GMP activities in assigned Operations function. * Ensures that manufacturing facilities, equipment, processes, and procedures are compliant with cGMP requirements and/or other applicable regulations * 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 * Responsible for ensuring that risks are identified, assessed, and corrected, to ensure the safety, purity, quality, and effectiveness of the product(s) manufactured * Ensures that written procedures describing the instructions to execute GMP activities are controlled, approved, and followed * May be required to own or provide subject matter expertise to nonconformance investigations, corrective and preventive actions, change control records or validations * Ensures that non-conformances for areas of responsibility are reported promptly to the Quality unit and investigated per procedures * Ensures that corrective actions and preventive actions (CAPA) are managed and closed according to procedures * Ensures that unplanned ARMS records were investigated, corrected (if applicable ) , managed and closed according to procedures and timely manner. * Ensures that planned ARMS records were created, documented, managed and closed according to procedures and timely manner. * Completes required assigned training to permit execution of required tasks * Ensures the requirements of the Quality Management System are fulfilled * Ensure document periodic review activities are completed on time for documents owned by assigned areas of responsibility. * Alerts senior manager of significant quality, compliance, supply, and safety risks * Provides input for Management Reviews * Supports Continual Improvement initiatives, programs, and projects * Coordinates in conjunction with other functions activities such as maintenance, shutdowns, systems improvements, repairs, inspections and walkthroughs. * Prioritizes and escalates any activity that require immediate attention due to safety or regulatory risk * Contract suppliers to request quotes for activities related to your area of responsibility * Generate requisitions for activities related to area of responsibility following Quality and Safety requirements * Advises on technical strategy, policy and procedure. * Creates technical documentation to agreed standards. * Complete zone inspection activities as required * 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. * Be agile to apply short term and long-term solutions implementations. * Support, prioritize and provide feedback to the GLAM (obsolete equipment replacement) program. * Support the EHSS permits program and its trainings. * Support and be a liaison for all request form clients. *Position # 2:* Experience in Commissioning and Qualification of parenteral products, vision system, device assembly and packaging (Automatic and HMLV lines). *Position # 3:* * General packaging/engineering experience in final product manufacturing within the Pharma/Biotech Industry. * Excellent understanding of Good Manufacturing Practices (GMP) and Good Documentation Practices (GDP). * Strong knowledge of common materials used in pharmaceutical primary and secondary packaging (bottles, labels, trays, lidding material, leaflets, paperboard, sterile barrier packaging, corrugate, etc.). * Familiar with distribution testing per ASTM D4169 and ASTM, ISO, TAPPI, USP and EP testing standards. * Strong interpersonal, project management, technical problem solving and communication (written and verbal) skills. * Ability to work in teams and adapt to a continuously evolving environment. * 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. Pay: $40.00 - $42.00 per hour Work Location: In person