Craftworker, Metrology
2 months ago
We go where others won’t, taking on some of the biggest public health challenges to protect and enhance millions of lives, and create a better, more secure world. Here, you will join passionate professionals who advance their scientific, technical and professional skills to develop products designed-to protect and enhance life.
I. JOB SUMMARY
The Craftworker, Metrology is a skilled position responsible for the calibration and maintenance of instruments common in the pharmaceutical/biopharmaceutical industry. This includes not only the physical and skilled aspects to the job, but also planning and communicating work, working with software systems to document work performed according to Good Documentation Practice (GDP).
II: RESPONSIBILITIES
Responsible for maintaining day-to-day operations of the Manufacturing Support team as they relate to calibrated equipment and systems. Perform maintenance, repairs and calibrations of instrumentation, measurement and recording devices used in manufacturing, QC and R&D laboratories. Maintain calibration traceability integrity in compliance with written procedures, as well as preventative maintenance documentation and SOP's within cGMP requirements. Participate in cross-training and special projects with facilities and engineering departments. Participate in cGMP training and off sight training as they relate to manufacturing and seek ways to increase operational efficiency. Responsible for the technical and cGMP completion of calibration reports, LUMAC's, Corrective Work Orders, Preventive Maintenance Work Orders and vendor documentation. Ensure all Departments are satisfied with our customer service. Provide assistance and technical support or guidance to manufacturing and manufacturing development personnel as required/requested. Provide technical support to the materials management systems as required to support ongoing maintenance operations. Maintains a current and detailed knowledge of cGMP. Seek ways to increase operational efficiency and the conservation of company resources. Perform all Quality System functions including: Deviations: the ability to initiate, investigate root cause analysis, assess impact, and implement durable corrective and preventive actions to prevent future deviating events with the same or similar root cause(s). CAPA System: the ability to utilize this Quality System to identify and implement continuous improvement corrective and preventive actions for system level improvements. Procedure Revisions: the ability to create new procedures and revise existing procedures including Preventive Maintenance, Calibration, as well as performing Biennial reviews of existing procedures
The above statements are intended to describe the general nature of work performed by those in this job. It is not an exhaustive list of all duties, and other duties may be assigned.
III: EDUCATION, EXPERIENCE & SKILLS
HS Diploma 6+ years of related experience Prior cGMP experience is strongly preferred Proficiency in Microsoft Project, Word, and Excel Must be customer service and quality driven Working knowledge of the following maintenance functions: Metrology/Calibrations General Mechanical Troubleshooting/Repairs Laboratory Support Equipment
Per CDC guidelines, Emergent strongly recommends that all employees working on site are vaccinated to help ensure their safety, as well as the safety of fellow employees. This includes the use of good judgment when determining when the CDC guidelines advise that you stay home when ill.
There are physical/mental demands and work environment characteristics that must be met by an individual to successfully perform the essential functions of the job. This information is available upon request from the candidate.
Reasonable accommodations may be made to enable individuals with disabilities to perform all essential functions.
Emergent BioSolutions is an Equal Opportunity/Affirmative Action Employer and values the diversity of our workforce. Emergent does not discriminate on the basis of race, color, creed, religion, sex or gender (including pregnancy, childbirth, and related medical conditions), gender identity or gender expression (including transgender status), sexual orientation, age, national origin, ancestry, citizenship status, marital status, physical or mental disability, military service or veteran status, genetic information or any other characteristics protected by applicable federal, state or local law.
Information submitted will be used by Emergent BioSolutions for activities related to your prospective employment. Emergent BioSolutions respects your privacy and any use of the information submitted will be subject to the terms of our Privacy Policy .
Emergent BioSolutions does not accept non-solicited resumes or candidate submittals from search/recruiting agencies not already on Emergent BioSolutions’ approved agency list. Unsolicited resumes or candidate information submitted to Emergent BioSolutions by search/recruiting agencies not already on Emergent BioSolutions’ approved agency list shall become the property of Emergent BioSolutions and if the candidate is subsequently hired by Emergent BioSolutions, Emergent BioSolutions shall not owe any fee to the submitting agency.
