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 Engineer 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. Considerable judgment and initiative, as well as a scientific background are essential in identifying and resolving problems and making recommendations.
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 and Master Plans 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 and lead 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.
- Works on complex problems in which analysis of processes or data requires an in-depth evaluation of various factors with minimal over sight. Exercises judgement in selecting methods, techniques and evaluation criteria.
- Works independently and may provide guidance to lower level personnel or as a team member. Execute QbD experiments to support the development and characterization of new manufacturing processes.
- Independently manage multiple cross-functional projects that may require regulatory submissions.
- Effectively present complex technical information to guide decision making.
- 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 8 years of equivalent job experience in pharmaceutical manufacturing.
- Strong leadership 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 HVAC systems, aseptic rooms, sanitary processing, sterilization equipment, and WFI systems, computer control systems, cleaning processes and aseptic manufacturing.
- 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 Veeva 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 minimal supervision and guidance.
- Regulatory background in pharmaceutical development/research is a plus.
PHYSICAL/MENTAL DEMANDS AND WORK ENVIRONMENT CHARACTERISTICS
- 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 does not discriminate on the basis of race, color, religion, gender, age, national origin, disability, Protected Veteran status, sexual orientation, or any other characteristic protected by 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.