Sr. Specialist, Lab Metrology

Job Title:      Sr. Specialist, Lab Metrology         

Location:      Columbus, OH

Job Type:     Full time

Req ID:          7519

 

About Us:

As a developer, manufacturer, and supplier of essential medicines, Hikma Pharmaceuticals USA Inc. and its affiliates’ mission is to bring Better Health. Within Reach. Every Day.® for millions of patients around the world.  We are a trusted, reliable partner and dependable source of over 750 high-quality generic, specialty and branded pharmaceutical products that hospitals, physicians and pharmacists need to treat their patients across North America, the Middle East, North Africa and Europe.  Through our 32 manufacturing plants, eight R&D centers, and 8,500+ employees worldwide, we are always hard at work creating high-quality medicines and making them accessible to the people who need them.

 

Description:

We are committed to building a diverse and inclusive team and encourage applications from candidates of all backgrounds.  We are seeking a talented and motivated Sr. Specialist, Lab Metrology to join our team.  In this role, you will be responsible for performing aspects of group activities, such as compliance, maintenance, and repair of laboratory instrumentation and all related documentation. Acts as Project Manager for laboratory capital projects and oversees validation of instrumentation. Offers mentoring such as, training sessions, and troubleshooting techniques.

Key Responsibilities:

Oversees Calibration Program

• Communicates directly with service engineers and Quality Laboratory management.
• Drives the identification of root causes for instrumentation failures through impact assessment process.
• Communicate with Flow lanes, QA, and Compliance to document and complete CAPA’s
• Reviews vendor calibration documentation
• Performs peer review of all instrumentation calibration and training certifications
• Preforms calibrations in assigned areas using scientific knowledge of analytical chemistry and instrumentation.

Oversees Validation Program

• Reviews GMP/Lab/Equipment change controls
• Reviews validation protocols (IQ, OQ, PQ, VAPR)
• Works with Validation Department and Quality Assurance for approval of the validation plan
• Coordinate with laboratory management and IT for protocol execution

Project manager for capital projects

• Coordinates with laboratories to review instrumentation needs
• Coordinates budget with upper management to approve capital
• Works with Engineering for services needs and required infrastructure.
• Initiate and coordinate instrument validation process
• Reconcile asset process with Finance
• Dispose of assets at end of lifecycle
• Ensures instrument training is purchased/facilitated as required.

Conducts instrument repairs and maintains lab instrumentation

• Performs and/or coordinates repairs either individually, with a team, maintenance department, or with outside engineers.

• Maintains and schedules calibrations in database.

• Communicates directly with service engineers and sets expectations.

• Able to trouble-shoot in a timely and effective fashion to enable labs to meet release requirements

• Develops return on investment calculations for costly repeated repairs.

• Acts as area supports person for Analytical Development Department, QC Department, and Launch Analytics Department.

 

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