Sr. Specialist, Lab Metrology

Hikma Pharmaceuticals USA Inc.•Columbus, OH

About The Position

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.

Requirements

Bachelor’s Degree in Scientific/Technical/Related field required with a minimum of 5 to 8 years’ experience in a QC pharmaceutical laboratory or related field (food, chemical, or environmental).
Experience as laboratory instrumentation field service technician may be considered, or Master’s Degree in Scientific/Technical/Related field required with a minimum of 3 to 6 years’ experience in a QC pharmaceutical laboratory or related field (food, chemical, or environmental).
Experience as laboratory instrumentation field service technician may be considered, or PhD in Scientific/Technical/Related field required with a minimum of 0 to 3 years’ experience in a QC pharmaceutical laboratory or related field (food, chemical, or environmental).
Experience as laboratory instrumentation field service technician may be considered.
Knowledge of regulations relating to calibration of laboratory instrumentation, cGMP regulations relating to training and certified individuals.
Validation experience preferred
High Technical Complexity: Understand theory and operation of current technologies enough to make minor repairs, troubleshoot, prepare training materials, and write procedures. Also, must understand all aspects of analytical chemistry to review installation, operational, and performance qualifications of instrumentation.
Strong Ability to report to multiple customers – indirect reporting matrix to managers and directors in each lab. Must be able to handle multiple priorities and projects from each lab. Must be able to build consensus between multiple managers for harmonization of procedures and processes.
Position has the authority to make decisions as to repairs, investigations, and CAPA’s. Must be able to solve many problems brought by many chemists. Requires quick thinking and negotiation skills. Decisions directly affect compliance and operation of QC Labs, and Analytical Development lab. Failure results directly in instrumentation being out of service and can cause back orders. Failures can also result in 483s and warning letters from Food and Drug Administration (FDA) for compliance issues.
Must be familiar with most types of analytical instrumentation (HPLC, UV, GC) – theory, operation, and troubleshooting.
Must possess knowledge of analytical chemistry principles and theory.
Demonstrated 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.

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
Communicates with Scientists and gain buy-in for procedure updates
Build consensus with QLABS and AD management and analyst for procedure harmonization
Identifies opportunities for improvements in laboratory instrumentation
Drives cost-savings in the lab through thorough review of all instrument and service quotes

Benefits

Annual performance bonus, commission, and share potential
Auto enrollment in a Hikma-sponsored 401(k) program at a pre-tax contribution rate of 4% of eligible pay. Hikma will match 100% of the first 6% of eligible pay that you contribute
A generous paid time off (PTO) bank starting with 20 days (prorated based on hire date). Additional days granted upon reaching work milestone anniversaries
3 personal days (prorated based on hire date)
11 company paid holidays
Comprehensive benefits including health, dental, vision, mental health, disability, life insurance, prescription drug coverage, and a variety of voluntary benefits
Employee discount program
Wellbeing rewards program
Safety and Quality is a top organizational priority
Career advancement and growth opportunities
Tuition reimbursement
Paid maternity and parental leave