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