Engineering - Equipment Commissioning & Qualification; ECQ Engineer

Equipment Engineer, Equipment Commissioning & Qualification Operations

The Equipment Engineer, Equipment Commissioning & Qualification Operations supports the successful operation of laboratory, clinical and commercial manufacturing operations at their home site through interaction with internal team members and internal customers as well as external service providers. With minimum supervision and given general instructions, this individual carries out routine tasks and functions, and uses basic analytical skills to recognize and solve common problems of limited scope.

As a developing team player, the incumbent interacts with their immediate supervisor and personnel within their own work group to achieve team goals while building trust and collaborative relationships outside the immediate organization. The incumbent may be asked to lead small to medium sized projects in their area of responsibility and will be called upon to create and revise work processes or procedures that impact their immediate function or organizational unit.

The incumbent will be involved with writing deviations, investigations and supporting the implementation of change controls.

Required competencies include knowledge of cGMP, GXP, GAMP, SDLC regulations, including 21

CFR part 11, computer systems validation requirements and good documentation practices. Advanced knowledge of pharmaceutical, manufacturing and laboratory systems and equipment is also required. Strong written and verbal communication skills, excellent interpersonal skills, strong multitasking ability, and highly proficient computer skills in Microsoft Office Suite are necessary. Working knowledge of scheduling software and systems, and inventory management systems, mainly Blue Mountain RAM, is also needed.

Ability to interact effectively with laboratory, QA and Facilities groups is essential.

Education and experience required include a BS in Engineering or Science related discipline preferred, minimum 2 years' experience in FDA-regulated industry, experience working directly with bench top manufacturing and laboratory equipment, knowledge of cGMP in the pharmaceutical industry, and strong problem-solving skills, strong verbal and written communication skills, and the ability to work independently. Must have strong interpersonal and communication skills, be a team player and be willing to work in an environment where individual initiative, accountability to the team, and professional maturity are required.

2 years of maintenance coordinating / planning experience, preferably in a laboratory environment is also required.

Duties and responsibilities include executing equipment calibration, preventative maintenance, performance verification and repair activities in both laboratory and manufacturing areas, supervising vendors for calibration, preventative maintenance, performance verification and repair functions, reviewing and approving vendor executed calibration, maintenance, repair, and performance verification records for accuracy, completeness and compliance to Client standards, working closely with and entering data into the site CMMS system, ensuring all calibration, PM, and performance verification records are filed appropriately after approval, writing and supporting deviations and investigations that result from calibration or performance verification failures along with developing and supporting the implementation of corrective and preventative actions, supporting the development, revision and review of written procedures for calibration, preventive maintenance and performance verification of equipment, supporting the development, review and approval of calibration and maintenance plans in site CMMS system, supporting the execution of equipment performance verification and process improvement studies, adhering to all policies and procedures which govern the ECQ team and the equipment they manage in order to ensure compliance is held to the highest standard, regularly reviewing, prioritizing and promptly responding to customer equipment performance verification and support requests, providing technical support and guidance on calibration, equipment performance verification and validations issues, maintaining a positive relationship with all the members of the Equipment Commissioning & Qualification department and site customers while promoting a positive team environment, working with planning group to ensure system is updated as calibration, maintenance and performance verification activities are performed, maintaining all required Corporate, Facilities and EHS training as required, adhering to all safety procedures and hazard communication, and may be called upon to act as SME in both internal and regulatory audits.