Manufacturing Sr Engineer I
At Zimmer Biomet, we believe in pushing the boundaries of innovation and driving our mission forward. As a global medical technology leader for nearly 100 years, a patient’s mobility is enhanced by a Zimmer Biomet product or technology every 8 seconds.
As a Zimmer Biomet team member, you will share in our commitment to providing mobility and renewed life to people around the world. To support our talented team, we focus on development opportunities, robust employee resource groups (ERGs), a flexible working environment, location specific competitive total rewards, wellness incentives and a culture of recognition and performance awards. We are committed to creating an environment where every team member feels inspired, invested, cared for, valued, and have a strong sense of belonging.
What You Can Expect
The Manufacturing Sr. Engineer I is responsible for providing manufacturing engineering services to support efficient manufacturing processes. Engineering services may include cell management, process development, project management, process validation, tool design, and troubleshooting.
How You'll Create Impact
- Creating, maintaining, and improving controlled technical documents such as prints, procedures, documentation including Factory Acceptance Tests (FATs), Site Acceptance Tests (SATs), Commissioning documents, Validation documents (IQ, OQ, PQ, and PV), Functional Requirements and User Requirement Specifications (FRS/URS), technology transfer documents, Operation Project Plans (OPPs), and Validation Master Plans (VMPs)
- Quality oriented, with strong ethical values and integrity
- Conducting feasibility study to estimate product cost and analyze capital equipment, capacity, and capability requirements affecting the make versus buy decision
- Primary SME support for biologics manufacturing including aseptic processing through fill finish.
- Developing and supporting a wide variety of processing applications such as chemical processing, packaging, cleaning, bottle filling, etc.
- Conducting feasibility studies on advanced processes to estimate product cost and analyze capital equipment, capacity, and capability requirements.
- Developing, leading, and executing project plans and schedules for work activities
- Communicating (written and verbal) direction and project plans with appropriate personnel from other departments
- Evaluating multiple options to select the most appropriate processes
- Leading equipment qualification or process validation project(s)
- Improving process methods which meet performance and quality requirements.
- Ability to handle and prioritize multiple medium complexity project assignments and complete work in a timely manner.
- Hands on approach to installation, troubleshooting, diagnostic and repair of equipment
- Developing rationale to set new process performance and quality standards
This is not an exhaustive list of duties or functions and might not necessarily comprise all of the essential functions for purposes of the Americans with Disabilities Act
What Makes You Stand Out
- Sound understanding of concepts and principles for manufacturing and new product processing and a basic knowledge of these elements in areas such as Quality, Development.
- Skilled and knowledgeable in aseptic manufacturing processes including sterile filtration and testing.
- Full working knowledge of all supporting department needs and capabilities, including the ability to discern when inaccurate information is supplied and offer ideas for how to correct it.
- Extensive knowledge of mechanisms required to implement processes and manage product flow
- Full working knowledge of the development process and procedures.
- Competence with drafting standards and geometric dimensioning and tolerancing
- Experienced with control procedures, such as the Change Management System, Nonconformance Reports, Engineering Specifications, Corrective and Preventive Action (CAPA), and Work Instructions
- Ability to lead and prioritize complex projects assignments and complete work in a timely manner
- Good problem-solving skills through the use of quality and statistical tools
- Ability to effectively work and communicate within a cross-functional team to complete critical project tasks.
- Demonstrates Strong written and verbal communication, exhibiting a high-level technical expertise, tact and discretion.
- Drafting software, SolidWorks preferred
- Six Sigma Green Belt or above
- Lean Manufacturing
- Microsoft Office Suite and Project.
- Minitab knowledge is preferred.
Your Background
- B.S.in Engineering with a minimum of 5-7 years of manufacturing engineering experience.
- Understanding Good Manufacturing Practices (GMP) is required. Experience working at an FDA regulated company highly preferred.
- Knowledge on how to conduct investigations and root cause analysis is preferred.
Travel Expectations
Up to 10%
Compensation
Salary Range: $82,000 - $109,000 USD
EOE/M/F/Vet/Disability
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