Sr Process Engineer
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.
I. JOB SUMMARY
The Sr. Process Engineer will lead technical engineering expertise within multiple areas of responsibility including engineering, validation, technology transfer and equipment/system maintenance. Develops and recommends new technologies to achieve cost effective and improved equipment/systems robustness. Develop plans and strategy for new product introductions; and establishes operating equipment specifications and improves manufacturing techniques/processes. This position is also a participant with the Manufacturing Technology team in the development and / or technology transfer of new solutions and modifications to our existing manufacturing process systems while adhering to established regulatory compliance requirements. The incumbent is responsible for developing appropriate solutions to satisfy the needs of internal customers in accordance with company guidelines and procedures, and within project budget and schedule commitments.
II. ESSENTIAL FUNCTIONS
Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions.
• Lead one or more tech transfer / high impact Engineering projects
• Conduct, plan, and lead cross functional projects of one or more processes into manufacturing
• Responsible for coordination of technical activities on assigned projects
• Evaluate incoming processes for operability and develop risk assessment plans
• Provide technical engineering oversight from development, to the implementation and routine operation on process equipment/systems.
• Develop documentation to support new equipment implementation (User requirement specifications, Detail design specification, Operating and Maintenance procedures, FAT, SAT, and commissioning documents).
• Perform conceptual analysis of new project proposals; feasibility analysis, scope of work, basis of design, project schedule, budgetary estimate, facility utilization, risk analysis and implementation plan.
• Implement engineering standards and best practices in the design of projects, specification of instruments and equipment, oversee/ coordinate the fabrication, installation and implementation of solutions to process problems.
• Troubleshoot and aid in the repair of process equipment/systems as required to maintain GMP standards for optimal performance. Responsible for ongoing optimization and improvement in equipment/systems/processes for long term robustness and reliability.
• Perform deviations/investigations/CAPAs/Change Control write-up. Provide engineering studies, technical engineering support, training and leadership to manufacturing, QA, validation, Quality Control, Validation, Facilities, and Metrology for continuous process improvement, troubleshooting, change control and deviation resolution.
• Author, review and approve all technical documents throughout the equipment/system lifecycle from commissioning and qualification through decommissioning and retirement.
• Execution and documentation of functional tests, protocols and qualifications for new systems.
• May be required to work with service providers and contractors while they are on-site performing maintenance, repairs and projects on buildings, systems and equipment.
• Interface with other departments and sites regarding special projects and quality issues as required.
• May be called upon to speak to regulatory agencies regarding manufacturing systems and equipment as a subject matter expert.
• Liaise with Quality Assurance and Regulatory Affairs and prepare/review documentation required for regulatory submissions and change controls.
• In areas of health, safety and environmental policy: Provide guidance, leadership and directives to support and comply with all policies. Contribute toward meeting departmental goals and demonstrate progress in preventing or reducing injuries.
• Requires vaccination against different viruses including vaccinia virus.
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.
III. MINIMUM EDUCATION, EXPERIENCE, SKILLS
Bachelor’s Degree in a science or engineering discipline or equivalent with 8+ years of process experience, Master’s degree with 4+ years process experience, or PhD with 2+ years process experience
Experience with Receiving and Evaluating Technology Transfer Data, Development of Bills of Materials, and Evaluation of GMP Manufacturing Suitability
Experience as a Project Lead
Strive for Results, Make Decisions, Lead Teams, Develop People, Think Strategically.
Extensive knowledge of GMP requirements, formulation, parenteral filling, inspection and packaging, commissioning and qualification required.
A self-motivating and goal-oriented individual with proven technical engineering skills. Must have strong oral and written skills with emphasis on technical writing for deviations/investigations/CAPAs.
This position requires strong analytical skills (ability to apply engineering principles to design), hands-on troubleshooting skills.
Quality Systems experience desirable.
Must be able to critically evaluate data summaries and conclusions.
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.