Analyst, GxP Metrology | BioNJ Talent Services

Analyst, GxP Metrology

Contact Information
Contact Name: 
Ferring Pharmaceuticals
Organization Name: 
Ferring Pharmaceuticals
Position Location: 
Parsippany
Company Profile: 

Ferring Pharmaceuticals is a globally recognized, research-driven, biopharmaceutical company with more than 65 years of history. Headquartered in Switzerland, Ferring is privately owned with over 5,700 employees in nearly 60 countries. In the United States, Ferring identifies, develops and markets innovative products in the fields of reproductive health (infertility), urology, gastroenterology, endocrinology, women’s health (obstetrics/gynecology) and orthopaedics. Ferring’s US operations employ approximately 800 people.

People Come First At Ferring. The Ferring Philosophy places people at the heart of what we do. This guides our relations with patients, physicians, employees, and other stakeholders. We invite you to share our passion for people and the power of science.

Job Description:

Summary:

Responsible for Metrology specialized instrumentation system maintenance practices up to and including calibrations, preventive maintenance, and troubleshooting of process and laboratory support instrumentation based equipment (i.e. filling, lyophilisation, autoclaves, stability, temperature controlled units and environmental control systems0. Reporting and documenting work through the Enterprise Asset Management System (EAMS) training, data input and monthly reporting and the EMS system, scheduling and coordination, follow up and monthly reporting, and, the calibration of all GxP systems at the Parsippany site.

The GxP Metrology Analyst will be responsible for documenting Instrument life cycle including but not limited to: Acquisition / Decommission, Routine and Non-routine activities, Change Management and reporting Out of Tolerance conditions through QA-Track incidents / deviation reporting (and in some case coordinate the documenting) and performing root cause analysis of deviation through investigation and also documenting CAPAs using the EAMs.

The GxP Metrology Analyst will implement Change via Change Management in QA-Track for the Process and Lab areas. Will provide expertise and assistance with calibration and maintenance program for: GxP equipment, clean utilities, GxP systems and utilities (DI, Clean Steam and WFI generation) for Production, Packaging and Laboratories. This role is for the Ferring commercial manufacturing site located in Parsippany NJ. Incumbent will support Equipment Service Support staff for Instrumentation systems either directly or indirectly using outside vendor support.

Responsibilities:

•EAMS updates, training, SOPs
•Responsible for an area of responsibility such as the clean utilities area for functionality, reporting KPIs and trouble shooting.Process, Laboratory and Hygienic Utilities equipment calibration planning and troubleshooting.
•Integrated reporting of Metrology activities to the Engineering & Maintenance Manager(s)

Calibrations:

•The incumbent will be fully responsible for an area of responsibility for the full functionality, trouble shooting and planning repairs to instrumentation systems.
•Responsible for ensuring the instrument technicians use the EAMS System to its full capacity within is area of responsibility and to review reports provided for accuracy against Ferring and Nationally recognized standards.
•Ensure EAMS is utilized to make the Facility and Maintenance department more efficient.
•Ensure factual and pertinent weekly and monthly for QRB reporting structure
•Utilize EAMs for spare parts inventory for instrumentation systems

Qualification:

•Aids in the planning of CQV activities, schedules, system boundaries/breakdowns and in interfacing with Project Planning, Technical Operations and Engineering for application where instrumentation is deployed and / or maintained through the life cycle management system

Quality:

•Initiate, track and resolve non-conformances associated with OOTs encountered during routine PM and calibration activities.
•Deviations management. CAPAs, etc.
• Responsible for the quality of Water for Injection (WFI), Clean Steam (CS) and De-Ionized Water (DI) produced at Ferring’s commercial manufacturing site located in Parsippany NJ

Operations:

•Author Calibration SOPs as needed to support calibration program
•Prepare daily work schedules for vendor direct reports
•Assist site management in all calibration related activities associated with new and/or modified areas within the production and laboratory departments up to but not limited to commissioning and validation support for source document and execution activities.
•Support installation of new instrumentation systems within the process equipment and other capital projects as required.

Systems responsibilities:

•Ensure the good functionality of the facility and utilities systems (24h / 365 days)
•Identify and mitigate maintenance risks
•Prepare preventive maintenance schedule, resource needs.
•Adhere to technical standards for projects and budgets (CAPEX & OPEX)considering future energy requirements for needs.
•Responsible for completing assignments on time and completing documentation for assimilation into the EAMs system for KPI tracking and weekly reporting on KPI’s for deviations, CAPA and change control.
•Provides resource for contractors and outside resources.

Qualifications: 

Requirements:

•Bachelor’s degree in Applied Sciences /mechanical/ Electronics or related field, or equivalent combination of education and work-related experience, required.
•Minimum 10 years in Production Maintenance role and or preferably in vaccine pharmaceutical facility start up or in GMP equipment installation, start-up and maintenance or supervisory experience in metrology and/or instrumentation & controls
•Minimum 10 years’ experience in maintaining and utilizing maintenance systems. (Maximo, EAMS, etc.)
•Good leadership skills to delegate work to peers and vendors to coordinate their work.
•Demonstrates potential for technical proficiency, engineering creativity, collaboration with others, and independent thought.
•Demonstrated troubleshooting and problem solving skills including the use of designed experiments. Strong teamwork skills.Ability to plan and perform multiple tasks/projects
•Good influencing and negotiation skills to accomplish the same goals for internal and external stakeholders according to Project and business need.
•Understanding maintenance disciplines, work package management and work package control.
•Knowledge of maintenance planning tools and Microsoft office applications.

Additional Job or Internship Information
Position Type: 
Full time job
Function: 
Other