Project Engineer (I-III)

Project Engineer (I-III) SteriPack Group

• 3.

2 Lakeland, FL Job Details 9 hours ago Qualifications Vendor relationship building Full Job Description Position Summary The role of Project Engineer (I-III) is to provide technical and project management leadership in the delivery and support of technical projects, driving cross-functional execution, managing resources and schedules, and ensuring adherence to PMI stage gate quality and control guidelines throughout the full systems development life cycle. This role is also responsible for leading the management of issues, risks, and project change requests to ensure successful, on-time project delivery, while contributing to process improvement initiatives across the business. The Project Engineer (I-III) is responsible for supporting day-to-day project execution activities and helping ensure the project produces the required quality deliverables within the specified constraints of time and cost, while achieving the potential benefits defined in the business case. Duties & Responsibilities Develop, configure and optimize processes from inception through to start up and validation. Maintain and document development plans through product development cycle. Comply with PMI control process and meet Quality Management System requirements. Communicate with external vendors to set expectations, track risks, and ensure timely delivery to meet program goals. Developing and maintaining project plans, design strategies, validation plans, and other project-related activities as applicable. Track and report progress against plan. Development of materials specifications, product structures, process routing and equipment requirements along with project related documentation including control plans, work instructions, manufacturing procedures, sample request, process guides and troubleshooting guides in accordance with QA/regulatory requirements. Responsible for the Development, Execution and Reporting of

IQ, OQ, PQ

where appropriate. Support development, ordering and control of process related tooling, equipment and materials. Effectively communicate with external/internal project members, customers, suppliers and service providers. Ensures compliance with company and regulatory policies and procedures. Perform and participate in design reviews, risk assessments, quality plans, supplier assessments. Support improvements in manufacturing efficiency, production yields, product quality and consistency through equipment and product design modifications and fabrication. Support Design, Selection, Modification and improvement of equipment and subsequent validation for medical device and pharma manufacturing. Engineering support which includes vendor contact and auditing specification. Develops/improved processes, sampling activities and as well as tooling and manufacturing concepts that will meet customer expectations on cost, quality and delivery. Provide technical assistance and engineering support to the manufacturing floor in ensuring production of quality products. Work with other support departments to maintain on-time delivery goals. Other duties as assigned by the Program Manager. Education/Skills Preferred Bachelor's degree in engineering, science and technology. 5+ years of experience in a manufacturing environment with experience in Process/Product development with Medical Device or Pharmaceutical Packaging knowledge including; Serialization, Assembly, and cleaning knowledge

• Preferred. Regulatory environment experience
• Medical device, Pharmaceutical, Bio-Tech and/or Food
• Preferred.

Excellent written and oral communication skills. Knowledge of

FDA, GMP, ISO

13485 and other industry standards

• Preferred.

Ability to organize and manage multiple priorities while consistently meeting deadlines. Proficient in MS Suite and Statistics Software (Ex. Minitab). Self-directed and detail oriented with analytical skills and an inquisitive nature. Good organizational skills and experience working as part of a team. Excellent verbal and written communication skills.