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.
Responsible for Engineering Compliance, specializing in the development of engineering related documentation including but not limited to Projects, Change Management, Deviation Reporting, Investigations and Corrective / Preventive Action development and effectiveness follow up. The ECA will coordinate and communicate with engineering, maintenance, and quality assurance in order to close all records within the allowable timeframes. The ECA will be the point of contact with our Quality team to ensure completeness and accuracy in the reporting of engineering documentation. The ECA will be responsible to provide updates to the GxP Engineering / Maintenance Manager.
The ECA will support document reviews and attach all pertinent GxP supporting documentation to the compliance systems that are available including; Enterprise Asset Management System (EAMs), Real Documentation Tracking, and QA-Track specifically. The ECA will be responsible for building the Action Grid (activities to be completed for documentation) and following up on their status, inputting results directly when applicable in order to expedite records.
The ECA will implement Change via Change Management in QA-Track for the Process and Lab areas. Will provide expertise and assistance with Engineering 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 Engineering, Facilities and Metrology either directly or indirectly using outside vendor support.
- QA-Track, EAMS, training, and SOPs - Provide finished reports and writing. The writing will be a result of collaborative efforts between multiple engineering and faciltiy disciplines. The key focus is liassoning with the Quality group to effectively communicate and innovate plausible corrective and preventive actions.
- Responsible for an area of responsibility such as; reporting KPIs and problem solving. Process, Laboratory and Hygienic Utilities equipment root cause analysis. Reporting out the effectiveness verifications for first time occurences and also to visit recurring issues
- Integrated reporting of Engineering, Maintenance and Metrology activities to the GxP Engineering & Maintenance Manager
- The incumbent will be fully responsible for the development of investigation planning to effectively evaluate abhorrent results to GxP systems including impactful events within the utility systems.
- Responsible for ensuring the timely completion of engineering compliance documentation through close collaboration with the Quality team.
- Ensure EAMS is utilized to facilitate the completion and attachment of critical documents. Make the Engineering Maintenance department more efficient.
- Ensure factual and pertinent weekly and monthly reporting for Quality Review Board reporting structure
- Utilize EAMs for timeline development and to document reverse traceability matrix and investigational determination of root cause and CAPA assignment.
- Maintain personal and professional training in order to be aligned with GxP (GEP, cGMP, GLP etc.) and all state and federal regulatory codes and laws.
- Provide frontline review and augmentation of engineering documents such as: TOPs, RFPs, RFIs, Bid Package Review and Technology selection tracking.
- Bachelor's degree in Applied Sciences /Mechanical/ Electrical or related field, or equivalent combination of education and work-related experience, required.
- Minimum 5 years in Engineering / role and or preferably a Certified Quality Engineer through ASQ
- Experience with pharmaceutical facility start up or in GMP equipment installation, start-up and maintenance or supervisory experience in Engineering / Maintenance Groups
- Minimum 5 years' experience in maintaining and utilizing maintenance quality systems. (QA-Track, Maximo, EAMS, etc.)
- Good leadership skills to delegate work to peers and vendors to coordinate their work.
- Demonstrates technical writing 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 engineering / maintenance disciplines, work package management and work package control.
- Knowledge of maintenance planning tools and Microsoft office applications.
We are proud to be an Affirmative Action/EEO Employer. EOE Minorities/Females/Protected Veterans/Disabled
We maintain a drug-free workplace and perform pre-employment substance abuse testing.
If you need assistance during the application process due to a disability, please email firstname.lastname@example.org.