Those who join Emergent BioSolutions feel a sense of ownership about their future. You will excel in an environment characterized by respect, innovation and growth opportunities. Here, you will join passionate professionals who advance their scientific, technical and professional skills to develop products designed-to protect life.
Provide support for 24/7 cGMP manufacturing operations with regards to troubleshooting, repairs, and preventative maintenance for cleanroom and lab equipment.
Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions.
• Monitor cleanroom equipment and system performance.
• Maintain various clean room equipment (autoclaves, bioreactors, chromatography skids, columns, mixers, tangential flow filtration systems, etc.).
• Assist with troubleshooting of mechanical and electrical systems associated with processing systems.
• Perform planned and unplanned maintenance.
• Develop an overall reliability program for process and process support equipment used in the production of biologic drug substance.
• Work with and manage equipment vendors.
• Maintain records of building operations, repairs, parts and equipment.
• Assist with the creation of Preventative Maintenance documents and Standard Operating Procedures.
• Assist with writing Deviations, CAPAs, Change Controls and SOP Revisions.
• Perform failure investigations (root cause) and help provide corrective/preventive actions.
• Support 24/7 plant and process operations in a cGMP environment.
• Must be able to work flexible shifts including weekends.
• Must be able to respond to an emergency on call.
• Must comply with all applicable rules and regulations of Emergent and the Pharmaceutical / Biotech industry. This includes FDA regulations such as cGMP, GDP, EH&S regulations and company regulations such as the employee handbook.
The above statements are intended to describe the nature of work performed by those in this job and are not an exhaustive list of all duties. Nothing in this job description restricts managements right to assign or reassign duties and responsibilities to this job at any time which reflects management’s assignment of essential functions.
MINIMUM EDUCATION, EXPERIENCE, SKILLS
• HS Diploma or equivalent.
• Prior experience working in a biotechnology production or development cleanroom.
• Prior experience with critical utility systems, purified water systems, clean steam, pharmaceutical gasses, classified HVAC systems.
• Must have the ability to multi-task and coordinate workload by priority.
• Must be customer service and quality driven.
• Prior cGMP experience.
• Prior experience with SAP Maintenance functions preferred.
• Prior experience in an environment such as advanced maintenance techniques such as preventive and predictive maintenance programs (PMMS, TPM, Predictive Maintenance).
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.
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.