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 approximately 6,500 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), orthopedics and Oncology. Ferring's US operations employ approximately 900 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 process equipment engineering, overseeing, guidance, scheduling and coordination required to fully implement process equipment engineering projects in order to support manufacturing, QA, Tech services, IT, Procurement, other departments, external vendors and goverment agencies as required. The incumbent is considered a Subject Matter Expert (SME) responsible for all aspects of production equipment (complete sterile manufacturing train) and its interfaces including mechanical, electrical, process plumbing, and safety interfaces. The incumbent must have superior troubleshooting and problem solving ability to ensure minimal down time and interruption to production schedule. The incumbent interacts with Production, QA, Tech services, IT, and other departments as nessessary obtain all applicable stake holder(s) information and decisions to collaberate high quality low risk results. The process equipment engineer must have a very clear understanding of the applicable aseptic / sterile processing guidelines for industry and engineering practices to ensure a compliant decision making. The incumbent must have project management skills to clearly define deliverables and timely acheivement of schedule driven activities (projects ranging from $10K to $5.5MM).
Responsible for the process engineering of equipment to meet the needs of existing and new products.
Perform interface with end user to ensure scope, identify deliverables and expectations are clearly defined
Involve all stake holders for proper collaborative results
Review FS, URS and other support documentation for correctness
Plans, schedules, coordinates and perform activities for engineering functions and partners. Coordinate production equipment projects within budget and in accordance with assigned timelines.
Responsible for the continuous improvements of production equipment utilizing GEP and change management procedures.
Provide redline drawings for updating and issuance within change management process following applicable drawing management procedures.
Maintain schedule integrity for projects related to production equipment and their support clean utilities following Good Engineering Pratices and design.
Plans, prioritizes and coordinates execution of work with affected departments and vendors. Ensures all safety requirements are reviewed and in place before work is executed.
Provide frontline engineering support to all phases of production, from the time the issue is recognized until solved and communicated properly to end users.
Perform Root cause analysis for incidents and investigations performs execution of steps to prevent them (CAPA)
Provide safety work permit, verify staff and contractor training on Safety Health & Environmental procedures. Ensure adherence to safety SOPs when executing maintenance activities.
Review/approve documentation to ensure accurate, concise documentation is submitted and meets all cGMP requirements and internal SOP's.
Bachelor's degree in engineering or a science related discipline preferred or equivalent combination of education and work related experience.
Current experience in leading problem solving and resolution within production line environments
Must be familiar and able to utilize applicable industry standard and guidelines as well as answering any challenges to the standards (GxP, PDA, ISPE, EU Annex 1, electrical code ETC.)
Minimum eight (8) years of pharmaceutical industry or related engineering experience. Key performance within troubleshooting and root cause analysis coupled with CAPA implementation
Proven experience in coordination of complicated engineering tasks
Knowledge and hands on experience production systems
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.
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Ferring Pharmaceuticals, Inc.