Equipment Validation Specialist
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.
The Specialist position will design and prepare all protocols and reports related to novel and diverse validation activities. The candidate will focus on Cleaning, Equipment, Utilities, and Software Validation. The Engineer will network with senior internal and external personnel in their area of expertise and work on problems where analysis of data requires evaluation of identifiable factors and troubleshooting of abnormalities.
Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions.
• Write, execute, and approve validation and re-validation protocols and reports, (IQ / OQ / PQ), for the validation of new and existing processes, equipment, systems, etc.
• Write summary reports, following good documentation practices.
• Use Kaye Validator, DataTrace dataloggers, and/or Ellab ValSuite dataloggers to perform mapping studies.
• Write and revise SOPs as part of process improvements.
• Analyze statistical data to verify acceptable criteria.
• Develop testing strategies and rationale for equipment/systems.
• Provide technical support/troubleshooting for process and equipment issues.
• Attend production and team meetings, as required.
• Maintain close contact with manufacturing, facilities, and laboratory departments to assure effective communication on issues related to validation.
• Apply CGMP guidelines to all aspects of validation.
• Investigate/resolve deviations associated with validation studies.
• Assist with commissioning, FATs, and SATs.
• Author technical documents such as protocols, reports, deviations, gap analyses, risk assessments, etc.
• Provide technical and/or investigational support in troubleshooting and resolving manufacturing equipment issues.
• Support the technical transfer team, Project Management, and business development in determining and planning studies required for new products.
• Perform periodic review of equipment /systems.
• Critically review complex data to ensure completeness, accuracy and compliance.
• Qualify change parts for fillers, cappers, vial washers, labeler, cartoner, and serialization machines to support new products.
• Write and revise SOPs and Master Plans biennially or as part of process improvements.
• Maintain close contact with Production, Facilities Maintenance, and Laboratory Services to assure effective communication on validation issues.
• Apply CGMP and CGDP to all areas of work.
• Support regulatory services with CMC preparation, product reviews and Client and Regulatory audits.
• Assist in cleaning validation activities and plans associated with projects at the site.
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
BS in Science or Engineering with minimum of 5 years of equivalent job experience in pharmaceutical manufacturing.
• Strong organization and communication skills; high level of personal/departmental accountability and responsibility.
• Ability to manage multiple priorities and tasks in a dynamic environment.
• Excellent written and verbal skills.
• Experience and knowledge of sterile processing (rooms, equipment, HVAC, etc).
• Ability to exercise judgment to determine appropriate corrective actions.
• Ability to exercise judgment for defined practices and policies in selecting methods and techniques for obtaining solutions.
• Ability to use computer programs such as Microsoft Office, EDMS, and SAP.
• Ability to work in a team environment.
• Proficient knowledge of CGMP.
• Coordinate multiple tasks simultaneously.
• Ability to make sound decisions regarding compliance-related issues with moderate supervision and guidance.
• Experience and knowledge of HVAC systems, clean rooms, sanitary processing, sterilization equipment, and WFI systems, computer control systems, cleaning processes and aseptic manufacturing is very desirable.
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.