Process Excellence Associate

We are seeking a Process Excellence (PE) Associate to support the Process Excellence team execute 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 to 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

**Direct Applicants ONLY - No Staffing Agencies or Third-Party Recruiters.

Responsibilities:

• Provide first response troubleshooting and support for malfunctioning equipment and/or parts, escalate complex issues as appropriate.


• Organizes and maintains all equipment forms and 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


• Performing preventative and corrective maintenance on equipment


• Performs IQ/OQ and PQ if applicable for equipment, documenting as appropriate.


• Assist PE team with continuous improvement tasks


• Training staff on new and existing equipment usage and maintenance


• Assisting quality in investigations and risk assessments.


• Assist in Onboard new equipment and procedures (process improvements, efficiency and/or customer requirements).


• Assist in Ensuring equipment is controlled according to the SOP.


• Working on new projects assigned by the Process Excellence Engineer &/or Director of Process Excellence as needed by the business.

Education:

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

Knowledge & Skills:

• 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 &/or Building management systems and controls is a plus


• Strong ability and desire to troubleshoot complex equipment and process issues.


• Familiarity with SOPs, WI’s, Qualification, Calibration and Validation documentation.

Physical Requirements:

• 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