Senior Manufacturing Engineer

Job Title: Sr. Manufacturing Engineer

Location: Virginia

Duration: 6–9 Months

Job Description

We are seeking a Sr. Manufacturing Engineer with a strong background in Mechanical Engineering, Manufacturing Engineering, or Process Engineering to support automated manufacturing operations in a regulated environment. The ideal candidate will have hands-on experience with equipment design, line modifications, installation, process optimization, and engineering assessments. Experience within the pharmaceutical, biotech, medical device, or life sciences industry is highly preferred. This role requires close collaboration with engineering, automation, quality, validation, vendors, and third-party contractors to support manufacturing projects, equipment upgrades, and operational excellence initiatives.

Key Responsibilities

• Lead and support process engineering activities, including the design, development, and optimization of automated manufacturing systems.
• Develop line layouts and custom fixtures for modifications to existing manufacturing equipment and production lines.
• Generate and maintain technical documentation, including engineering drawings, diagrams, User Requirement Specifications (URS), Standard Operating Procedures (SOPs), and Work Instructions.
• Coordinate with vendors and third-party contractors to communicate site, equipment, and product requirements and ensure successful project execution.
• Manage and support small to mid-sized engineering projects while collaborating with cross-functional teams.
• Provide Subject Matter Expert (SME) support for Commissioning, Qualification, and Validation (CQV) activities related to facilities, utilities, equipment, and manufacturing processes.
• Conduct engineering gap assessments, risk assessments, and feasibility studies to support continuous improvement and regulatory compliance.
• Ensure compliance with cGMP requirements, FDA regulations, and applicable industry standards.

Required Qualifications

• Bachelor’s degree in Mechanical Engineering, Manufacturing Engineering, or a related engineering discipline preferred.
• 5–10 years of experience in Manufacturing Engineering, Mechanical Engineering, or Process Engineering.
• Hands-on experience working in automated manufacturing environments.
• Strong mechanical or manufacturing engineering background.
• Experience performing engineering gap assessments.
• Proficiency in 2D drafting and 3D modeling.
• Experience with equipment design, equipment modifications, installation, and manufacturing line layout development.
• Proficiency with AutoCAD and SolidWorks.
• Familiarity with PLCs and HMIs, with the ability to effectively communicate and collaborate with automation and controls teams.
• Experience developing technical documentation, including URS, SOPs, Work Instructions, and engineering drawings.
• Strong communication, documentation, and project execution skills.
• Experience working in a cGMP-regulated manufacturing environment.

Preferred Qualifications

• Experience within the pharmaceutical, biotechnology, medical device, or life sciences industry.
• Fill-finish manufacturing experience.
• Experience with filling, capping, and labeling equipment.
• Experience supporting CQV activities as an SME for facilities, utilities, equipment, or manufacturing processes.
• Experience managing small to mid-sized engineering projects.
• Experience working with vendors and third-party contractors on equipment design, installation, modification, commissioning, or startup activities.
• Strong understanding of FDA regulations, cGMP requirements, and regulated manufacturing standards.