Equipment Engineer

Job Description:

• 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.

Knowledge, Skills, and Abilities:

• Knowledge of cGMP, GXP, GAMP, SDLC regulations, including 21CFR part 11, computer systems validation requirements and good documentation practices.
• Advanced knowledge of pharmaceutical, manufacturing and laboratory systems and equipment.
• Strong written and verbal communication skills.
• Excellent interpersonal skills with experience dealing with a diverse workforce where individual initiative, accountability to the team, and professional maturity are required.
• Strong multi‐tasking ability in conjunction with proven organizational skills. Ability to organize assigned tasks in a high paced environment and concurrently monitor tasks / assignments with others that may impact timely completion. Ability to effectively manage multiple tasks and activities simultaneously.
• Highly proficient computer skills in Microsoft Office Suite – Word, Excel, PowerPoint and Outlook with extensive background in database systems. Innate ability to learn new software, such as corporate intranet and enterprise business.
• Working knowledge of scheduling software and systems, and inventory management systems, mainly Blue Mountain RAM.
• Ability to interact effectively with laboratory, QA and Facilities groups.

Education and Experience:

• 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 (cell counters, liquid handlers, Flow Cytometry, etc.) preferred.
• Knowledge of cGMP in the pharmaceutical industry
• Excellent computer skills including knowledge of calibration management and environmental monitoring systems
• 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.
• Experience working in a commercial environment preferred.