Job Title: Engineering Associate

Work Location: Bucks County, Pennsylvania

Summary:

Seeking an Engineering Associate to support the Facilities and Engineering Department in the development, qualification, and continuous improvement of equipment, systems, and utilities for oral solid dosage pharmaceutical manufacturing. This role involves authoring and executing qualification protocols, supporting change control, and contributing to process optimization and technical problem-solving initiatives.

Responsibilities:

• Prepare, review, and execute qualification and validation protocols for manufacturing, packaging, and facility systems.
• Maintain and update Standard Operating Procedures, preventive maintenance, and calibration instructions in compliance with cGMP standards.
• Participate in equipment and system changes through the Change Control process, ensuring thorough documentation and traceability.
• Conduct area qualification activities, temperature mapping, and environmental monitoring for controlled spaces as needed.
• Utilize engineering tools such as AutoCAD to update and maintain facility and equipment drawings.
• Assist with the design, installation, and commissioning of new equipment or facility upgrades, collaborating with cross-functional teams.
• Identify and implement opportunities for cost savings and process efficiency using Lean and Six Sigma methodologies.
• Support investigations, root cause analysis, and corrective/preventive actions related to equipment or facility deviations.

Qualifications:

• Bachelor’s degree in Engineering required.
• 1–5 years of engineering experience in a regulated manufacturing environment, preferably in the pharmaceutical or medical device industry.
• Experience with equipment qualification, project management, and technical documentation under cGMP conditions.
• Proficiency with AutoCAD, Microsoft Office, and computerized maintenance or document management systems preferred.
• Strong understanding of validation principles, equipment qualification, and change control processes.
• Knowledge of mechanical and electrical systems common to pharmaceutical manufacturing and packaging operations.
• Excellent analytical and problem-solving skills; ability to interpret technical drawings and specifications.
• Strong written and verbal communication skills with attention to detail and documentation accuracy.
• Ability to manage multiple projects with minimal supervision in a fast-paced environment.

Published Category: Manufacturing & Technical Operations