1+ months

Sr. Engineer, MS&T

Baltimore, MD 21202
  • Jobs Rated
    8th


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.

JOB SUMMARY

The Manufacturing Engineer position reports to a Principal Engineer or the leader of the Manufacturing Development Department at the Emergent Bayview Manufacturing Facility. The position is responsible for leading process and technology transfer of one or more processes into GMP facility. Conducts, plans, and leads tech transfer and GMP documentation. Represents Manufacturing Development/company at internal and external meetings. This includes but is not limited to creating process budgets, managing internal and external resources, participating in project team meetings, reporting project schedule status, and providing in-suite support for EMOB GMP manufacturing campaigns.

ESSENTIAL FUNCTIONS
Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions.

Lead one or more tech transfer projects
Conduct, plan, and lead tech transfer 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
Work with external groups to support tech transfer activities
Author and review technology transfer and manufacturing documentation including plans and reports
Develop Unit Operation and Batch Record Material Usage Requirements for SAP system
Author CMC Sections with assistance from Principal Engineer and/or Director
Compare manufacturing batches and evaluate process performance
Independently perform review of process control parameters and testing protocols
Develop experiments to allow evaluation of Key and Critical Process Parameters
Provide technical support to manufacturing in production suite as needed
Assist with implementation of Unit Operations in Manufacturing Suite
Contribute to and review process deviation risk assessment and CAPA reports
Author technical sections of project proposals including evaluation of CapEx requirements and costing
Determine equipment needs and CapEx for projects
Coordinate the efforts of support groups and external resources such as vendors, consultants, and contractors
Assist site validation with process and equipment performance qualification
Represent EBS to external customers at conferences and/or organizations
Lead by example through strong work ethics
All responsibilities of a Manufacturing Development Engineer

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 managements assignment of essential functions.

MINIMUM EDUCATION, EXPERIENCE, SKILLS

Minimum Requirements
Bachelors Degree in an engineering discipline or equivalent with 12+ years of process experience, Masters degree with 6+ years process experience, or PhD with 4+ years process experience
Process technology transfer experience in two or more of the following:

  • Downstream or upstream GMP manufacturing experience
  • Viral or non-viral process experience
  • Microbial or mammalian 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
Knowledge of cGMPs and experience working in a GMP biotechnology or pharmaceutical manufacturing setting
Detailed knowledge of facilities, systems, and infrastructure within a regulated industry setting
Experience with SAP or Equivalent ERP system
Experience with Facility Design/Expansion
Experience with Design of Experiments to support Process Validation

Preferred Requirements
Ability to operate process and analytical equipment and other instruments
Experience with authoring protocols and reports to facilitate technology transfer to a manufacturing environment
Familiarity with analytical methodologies for determining protein structure, concentration, and purity
Experience with writing SOPs, batch records, production protocols, deviation assessments, and technical reports for GMPs

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.

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.

ABOUT EMERGENT

Protecting and Enhancing 1 billion lives by 2030 focuses our energy to improve the quality of life for individuals around the world, giving them the opportunity to experience the fullness of life.

Our drive towards this vision informs all of our actionswhether it is our approach to product development, manufacturing, encouraging employee health and wellness or giving back to the communitywe strive every day to achieve this shared goal.

WE BELIEVE IN OUR VALUES

  • Stand shoulder to shoulder no matter what
    • We combine our best thinking and communicate openly to support each other.
  • Break through thinking
    • We take smart risks, pursue innovation and challenge ourselves to constantly improve.
  • Own it always
    • Every person at Emergent is engaged and accountable for delivering on our commitments.
  • Compete where it counts
    • We set the right goals and respect each other as we conquer them together.

Categories

Industry

  • Biotechnology

Jobs Rated Reports for Software Engineer

Posted: 2021-11-15 Expires: 2022-05-22

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Sr. Engineer, MS&T

Emergent BioSolutions Inc.
Baltimore, MD 21202

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