The manufacturing engineer is responsible for providing manufacturing engineering support for the efficient drug and device manufacturing processes. Engineering support may include cell management, process development, project management, process validation, tool and fixture design, equipment and process trouble shooting, and CI initiatives.
Principal Duties and Responsibilities
Creating, maintaining, and improving controlled technical documents such as prints, procedures, bill of materials, routers and life cycle documentation. Support 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.
Supporting a wide variety of processing applications in both drug and device manufacturing environments
Supporting cGMP the utilities required to support the drug / device manufacturing.
Conducting feasibility study to support product and process changes, estimate product cost and analyze capital equipment, capacity, and capability requirements
Establishing and improving process methods which meet performance and quality requirements
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, trouble-shooting, diagnostic and repair of equipment.
Communicate (written and verbal) direction and project plans with appropriate personnel from other departments.
Evaluating multiple options to select the most appropriate processes and machining methods, including design, performing engineering calculations, and technical reporting
Support equipment qualification or process validation project(s)
Assist in the security, setting, and maintaining production equipment passwords
Be a backup for supervision of manufacturing supervision.
Assist in issuing PO’s and maintaining in cell spare parts.
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.
Expected Areas of Competence
Skilled and knowledgeable in manufacturing and new product processing
Competence with drafting standards and geometric dimensioning and tolerancing
Ability to balance marketing, manufacturing, and design requirements to meet customer
Ability to lead and prioritize multiple medium complexity project assignments and complete
work in a timely manner
Good problem solving skills through the use of quality and statistical tools
Ability to effectively work within a cross-functional team to complete critical project tasks
Demonstrates good written and verbal communication skills
Experienced with control procedures, such as the Change Management System,
Nonconformance Reports, Engineering Specifications, Corrective and Preventive Action (CAPA),
and Work Instructions
Proficient with Statistical Process Control concepts, process development, and tooling design
AutoCad, Solidworks (and /or other solid modeling software), Visio, Minitab. Six Sigma training.
Microsoft Office Suite and Project
*B.S. in engineering with a minimum of 1-3 years of experience in an engineering role.
*B.S. in engineering with less than 1 year of experience in an engineering role, with other
professional experience would be considered, as well as body of knowledge.
*Understanding Good Manufacturing Practices (GMP) preferred but not required.
*Experience working at an FDA regulated company, preferred but not required.
Up to 10%