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Manager, Process Engineer

Company: Emergent BioSolutions
Location: Rockville
Posted on: March 28, 2020

Job Description:

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

  • 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.

              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. IV: Physical/Mental Requirements Type/keyboard, visual acuity, good eye/hand coordination, stand, walk, sit, twist/turn, climb, reach outward, reach above shoulder, hand dexterity, bend, squat/kneel, sense of feel, sense of hearing, sense of smell, lift/carry 20 - 50 lbs., and pull 20 - 50 lbs.

              Use phone, fax, copier, and computer.

              Use hand tools.

              Organize/coordinate, analyze/interpret, calibrate precise measurements, problem solve, make decisions, supervise, plan, communicate, prepare written communications, and prepare transaction documents.

              Drive automatic/standard vehicle.

              Work indoors or outdoors, around noise above conversation level, in hot/cold temperatures, in high humidity, in contact with select agents (e.g. H2O2).
              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.

              Information submitted will be used by Emergent BioSolutions for activities related to your prospective employment. Emergent BioSolutions respects your privacy and any use of the information submitted will be subject to the terms of our Privacy Policy .

              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.

Keywords: Emergent BioSolutions, Rockville , Manager, Process Engineer, Executive , Rockville, Maryland

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