Equipment Validation Specialist
Today, Lonza is a global leader in life sciences operating across three continents. While we work in science, there’s no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, we let our people own their careers. Their ideas, big and small, genuinely improve the world. And that’s the kind of work we want to be part of.
Lonza is actively seeking an Equipment Validation Specialist to join our team our team in Walkersville, MD. This role is responsible for the writing of and the execution of project and system qualifications, validations, re-qualifications and revalidation of manufacturing facilities, equipment, utilities and processes.
- Demonstrated ability to manage projects that are large and complex independently and with minimal oversight.
- Responsible for the writing of and the execution of project and system qualifications, validations, re-qualifications and revalidation of manufacturing facilities, equipment, utilities and processes.
- Able to train and supervise junior (I-III) level specialists.
- Good communication skills so as to be an independent interface to other portions of the organization as assigned. providing project updates, seeking out higher level input when necessary.
- Capable of discussing validation policies and philosophies during customer audits or regulatory inspections.
- Demonstrated ability to review policies or procedures for compliance with regulatory guidance.
- Able to correctly assess all change controls with an accurate understanding
- Review and approve deviations and validation protocol final reports
- Review / author URS’s and provide guidance and recommendations on an engineering project.
- Able to perform investigations of complex conditions with minimal oversight.
- Able to initiate deviations, be responsible for CAPA investigation and closure as required.
- Able to resolve discrepancies on the basis of risks involved. Able to correctly identify the impact to validation including other functional areas as well as the impact to process / product and identify further qualification needs.
- Able to correctly assess the impact of a study’s acceptance criteria and with input from supervisor / manager as required. Demonstrated technical writing skills and thorough understanding of root cause analysis.
- Participates in contamination investigations and process (CIP, SIP, Autoclave) failure investigations.
- Ability to author / review / Modify Templates as required.
- Assess impact of process / equipment or procedural changes that can affect the validated state of the equipment.
- Manage complex capital projects with minimal oversight from start to finish.
- Review process, SIP and CIP flowpaths with engineering, participate in the commissioning plan / effort where needed.
- Advanced knowledge of GMP’s and their application.
- Experienced with regulatory guidance’s applicable to equipment / cleaning validation, computer systems validation and process validation
- B.S / M.S degree or equivalent in technical area preferred, with substantial experience in pharmaceutical, biotechnology or related industry.
- Familiarity with the use of computers Word, Excel, Outlook, Project or equivalents.
- Ability to read and follow technical instructions in English.
- Ability to comply with detailed procedures.
- Ability to perform math with assistance from a calculator