Position Title: Engineer
Duration: 12 Months
Location: West Point, PA 19486

Responsibilities

• Support deviations, including product impact assessments, root cause investigations, and determination of corrective and preventive actions (CAPAs).

• Assist in writing investigations and quality incident reports.

• Author, support, update, and/or lead documentation updates, including:

  • SOPs

  • Batch records

  • Change control documents

  • Technical protocols

  • Validation documents

  • Other GMP documentation

• Support equipment and facility projects for the Sterile Supply areas.

• Support continuous improvement projects that increase compliance, reduce costs, and simplify or standardize processes.

• Examine complex issues from diverse perspectives, including safety, compliance, automation, equipment, process, and personnel, to identify and resolve root causes.

• Design, conduct, review, and approve experimental protocols as needed.

• Provide on-the-floor support for complex operational and technical process/equipment issues.

• Complete and/or lead projects focused on:

  • Investigation and execution of CAPAs

  • Improving Right-First-Time performance

  • Preventing and reducing deviations

  • Improving efficiency

  • Reducing costs

  • Increasing compliance

• Support team safety, environmental, and compliance objectives.

• Manage project timelines to ensure compliance and customer deadlines are met, escalating risks and developing remediation plans when necessary.

• Partner effectively with Operations, Quality, Planning, Project Teams, Automation, Maintenance, and external vendors.

Education Requirements

• B.S. or B.A. in Engineering, Sciences, or a related discipline.

• 2–4 years of experience (combination of co-op and industry experience acceptable).

Required Experience & Skills

• Strong technical writing skills.

• Highly developed communication, leadership, and teamwork skills.

• Ability to manage projects and work effectively to schedules and deadlines.

Preferred Experience & Skills

• Deviation management and investigation experience.

• Experience in biologics, vaccine, or bulk sterile manufacturing facilities.

• Change control experience.

• Experience in root cause analysis.

• Experience in a manufacturing environment.

• Ability to work in a fast-paced environment and meet aggressive deadlines.

• SAP and/or Power BI experience is beneficial.

 
 
At SPECTRAFORCE, we are committed to maintaining a workplace that ensures fair compensation and wage transparency in adherence with all applicable state and local laws. This position’s starting pay is: $ 50.00/hr.