Process Excellence Associate
Listed on 2026-05-08
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Engineering
Quality Engineering, Validation Engineer, Process Engineer, Maintenance Technician / Mechanic
Position Overview
We are seeking a Process Excellence (PE) Associate to support the Process Excellence team in executing hands‑on equipment lifecycle activities, qualification support, and facilities and environmental monitoring. This role serves as the execution backbone of the PE function, ensuring day‑to‑day technical work is performed in compliance with a GMP‑regulated environment. The PE Associate will work alongside the PE Engineer to support the upkeep of equipment, facilities and processes to ensure they are functioning as intended and meeting internal customer and regulatory requirements.
This is a 100% (Mon‑Fri) onsite role in Milford, MA – LOCAL CANDIDATES ONLY.
Responsibilities- Provide first‑response troubleshooting and support for malfunctioning equipment and/or parts, escalating complex issues as appropriate.
- Organize and maintain all equipment forms and the Equipment Management System.
- Monitor Building Management systems, responding to out‑of‑specification Temperature, Humidity, and Differential Pressure alerts and alarms.
- Assist in calibration, qualification, and validation activities on equipment.
- Perform preventative and corrective maintenance on equipment.
- Perform IQ/OQ and PQ for equipment, documenting as appropriate.
- Assist the PE team with continuous improvement tasks.
- Train staff on new and existing equipment usage and maintenance.
- Assist quality in investigations and risk assessments.
- Assist in onboarding new equipment and procedures (process improvements, efficiency, and/or customer requirements).
- Assist in ensuring equipment is controlled according to SOPs.
- Work on new projects assigned by the Process Excellence Engineer or Director of Process Excellence as needed by the business.
Associate's or Bachelor's Degree or technical certification in Engineering or Metrology is preferred.
Science related degrees or background is a plus.
Experience- Minimum of 0–3 years of experience working with equipment qualification, validation, or calibration.
- 1–3 years of equipment calibration or field service engineering is a plus.
- Working knowledge of SOPs, GMP documentation, and basic equipment operation is preferred.
- Ability to meet deadlines, multitask, and change priorities while maintaining productivity.
- Ability to work well independently and within a team.
- Familiarity with equipment used in the biotechnology industry.
- Experience with calibration and verification of lab equipment is preferred.
- Experience with environmental monitoring and/or Building Management Systems and controls is a plus.
- Strong ability and desire to troubleshoot complex equipment and process issues.
- Familiarity with SOPs, WIs, Qualification, Calibration, and Validation documentation.
- Stand and work in a lab environment for an extended period.
- Ability to lift and transfer up to 50 pounds.
- Work underneath a Biological Safety Cabinet for an extended period.
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