Deviation Engineer

TALENT Software Services; Lansdale (Montgomery County); On-site; USD 65,000 - 85,000; Full time

Job summary

TALENT Software Services is looking for a skilled professional to support quality and compliance efforts in Lansdale, United States. The candidate will manage deviations, update key documentation, and lead projects aimed at improving efficiency and compliance.

Qualifications include a B.S. or B.A. in Engineering or Sciences, strong technical writing skills, and experience in a manufacturing environment. This position may require collaboration with various teams to meet operational objectives.

Qualifications

• 2-4 years of experience in relevant fields.
• Ability to meet quick pace and hard deadlines.

Responsibilities

• Support deviations and quality incidents.
• Update documentation such as SOPs and change control documents.
• Conduct and review experimental protocols.

Skills

Technical Writing Skills

Communication Skills

Leadership Skills

Project Management

Root Cause Analysis

Education

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

Tools

SAP

Power BI

Job description

Education Requirements

B.S. or B.A. in Engineering, Sciences, or related discipline. 2-4 yrs experience (combination of co-op/Real world acceptable).

Required Experience and Skills

Strong Technical Writing Skills, Highly developed communication, leadership and teamwork skills, Ability to manage projects/work to schedule/deadlines.

Preferred Experience and Skills

Deviation Management Investigation. Experience in biologics, vaccine, or bulk sterile manufacturing facilities, Change Control experience, Experience in root cause analysis. Experience in manufacturing environment. ability to meet quick pace/hard deadlines. Any previous SAP and/or Power BI experience beneficial

Responsibilities

• Supports deviations, including assessment of product impact and determination of root cause and corrective/preventative actions, assists in writing of investigations as well as quality incidents
• Authors, supports, updates, and/or leads documentation updates such as SOPs, batch records, change control documents, technical protocols, validation documents and other GMP documentation
• Supports equipment and facility projects for the Incoming Materials, Supplies Inspection, Culture Media and Weigh and Dispense Operations, and Black Widow Spider areas.
• Supports continuous improvement projects that increase compliance, reduce cost, and/or simplify/standardize the process.
• Examines complex issues from diverse perspectives (safety, compliance, automation, equipment, process, and people) to best understand and resolve the root cause.
• Designs, conducts, and/or reviews and approves experimental protocols as needed.
• Provides on-the-floor support of complex operational and technical (process/equipment) issues.
• Completes and/or leads projects to improve the performance of our Company processes, including investigation and execution of Corrective/Preventative Actions (CAPAs); projects aimed at improving Right-First-Time performance or preventing/reducing deviations; and projects that seek to improve efficiency, reduce cost, or increase compliance.
• Supports team safety, environmental, and compliance objectives.
• Manages project timelines to ensure key compliance and customer due dates are met; escalates any potential delays and develop remediation plans when possible.
• Partners effectively with Operations, Quality, Planning, project teams, and external vendors.