Process Excellence Associate

Boston BioProducts•Milford, MA

15h•Onsite

About The Position

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.

Requirements

Minimum of 0 – 3 years of experience working with equipment qualification, validation, or calibration
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.
Familiarity with SOPs, WI’s, 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

Nice To Haves

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
Science related degrees or background is a plus
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.

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.