Manager, Process Engineer (33473_Rockville)
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
Individual will provide technical engineering expertise within multiple areas of responsibility including engineering, validation and equipment/system maintenance. Develops and recommends new technologies to achieve cost effective and improved equipment/systems robustness. Develops plans and strategy for new product introductions. Establishes operating equipment specifications and improves manufacturing techniques/processes. Plans and delivers capital projects. Supervises direct reports.
II: Responsibilities (Include key responsibilities only. This should not be an all-encompassing list)
• 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 for new capital 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.
• 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.
• Manage contract engineers, and engineering service providers depending on the current projects and workloads.
• Individual with experience must have knowledge of unit operations typically used in biotech and vaccine manufacturing such as bulk manufacturing, downstream operations, formulation, steaming (SIP) and cleaning (CIP).
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
Minimum of Bachelors degree in engineering (chemical, industrial, mechanical, or related discipline) Minimum 7 years of engineering experience in the field of pharmaceutical/biotechnology (or equivalent).
Strive for Results, Make Decisions, Lead Teams, Develop People, Think Strategically.
Supervises and manages direct reports in a manner that encourages collaboration and personnel development. Exemplifies leadership, integrity, and fosters the company core values. Enforces disciplinary actions as needed.
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.
Successful applicants for this position must be fully vaccinated against COVID-19 as a condition of employment. Individuals with qualifying medical issues or sincerely held religious beliefs or practices that may prevent them from getting the vaccine may request an exemption from the vaccine requirement.
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.
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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.