Title:  Specialist, GMP / Laboratory Equipment Engineer

Performs aspects of group activities, such as compliance, maintenance, and repair of laboratory instrumentation and all related documentation. Offers mentoring such as, training sessions, and troubleshooting techniques.

Responsibilities

Writes and reviews departmental work instructions (WI’s).  Identifies work instructions which require updates based on new processes, instrumentation, and regulatory requirements.

• Coordinates with management for content and to meet established timelines
• Communicates with Scientists and gain buy-in for procedure updates
• Build consensus with QLABS management and analyst for procedure harmonization

Performs instrument calibrations and monitors the calibration program

• Maintains, performs, reviews, and schedules calibrations

• Communicates directly with service engineers and Quality Laboratory management for impacted instrumentation.
• Identify root causes for instrumentation failures through impact assessment process with laboratory management.
• Communicate with Flow lanes to document and complete CAPA’s.
• Receives quotes from vendors.

Reviews Installation Qualification, Operational Qualification, Performance Qualification (IQ OQ PQ).

Conducts instrument repairs to ensure working and efficient laboratories through trending and data analysis. Identifies instrumentation which are no longer reliable or able to be maintained.

• Shows initiative and proactively works with Flow lanes to determine which instruments to retire.
• Performs and/or coordinates repairs either individually, with a team, maintenance department, or with outside engineers.
• Maintains, reviews, and schedules in database.
• Communicates directly with service engineers.
• Able to trouble-shoot in a timely and effective fashion to enable labs to meet deadlines

Mentors analysts on new or improved instrumentation and techniques To ensure growth and development of analysts as well as compliance.

• Trains required individuals and provides input on training modules for new/revised equipment.
• Prepares materials such as one point lessons.

Identifies opportunities for improvement in laboratory instrumentation to ensure working efficient laboratory.

• Performs needs assessments with QLABS and Analytical Development for new technologies
• Based on data available provides recommendations to management for new equipment purchases and drafts justification for purchase (APR)

Drives cost-savings in the lab through thorough review of all instrument and service quotes

Qualifications

• Bachelor’s Degree in Scientific/Technical field required with a minimum of 3 years’ experience in a QC pharmaceutical laboratory or related industry (food, chemical, or environmental).  Experience as laboratory instrumentation field service technician may be considered.
• Must be familiar will most types of analytical instrumentation (HPLC, UV, GC) – theory, operation, and trouble shooting.
• Extremely strong problem-solving skills and able to make general repairs to all types of laboratory equipment.
• Strong computer skills – able to learn new software on the fly, troubleshoot basic computer problems.  Set up and interface computer systems with lab instrumentation.
• Strong communication skills – written and oral – with the ability to teach and convey technical knowledge and develop training materials for others to use.
• Knowledge of GMP regulations, analytical instrument qualification, calibration, and DP requirements.

What We Offer

• Clean climate-controlled working environment 
• Annual performance bonus potential
• 401k employer match up to 6% of your contributions
• 23 vacation/personal days
• 11 paid Company holidays
• Generous healthcare benefits
• Employee discount program
• Wellbeing rewards programs
• Safety and Quality is a top organizational priority
• Career advancement/growth opportunities
• Tuition Reimbursement
• Maternity and Parental Leave

*Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to a specific plan or program terms.