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System One Services Process Validation Engineer in Baltimore, Maryland

Process Validation EngineerBaltimore, Maryland

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Type:Direct-Hire

Category:Scientific & Clinical

Job ID:154914

Date Posted:08/17/2020

  • Title:Process Validation Engineer

Location:Baltimore, MD

Type:Direct Hire, Salaried with Benefits

Start date:ASAP

Responsibilities:

  • Conduct, plan and lead tech transfer of one or more processes into manufacturing

  • Perform statistical analyses, and compare manufacturing batches and evaluate process performance

  • Support execution of Continued Process Verification strategy with MS&T team

  • Author and review technology transfer and validation documentation (including run summaries, reports and client presentations)

  • Develop, edit, review and sign cGMP documentation

  • Provide technical support for writing of project proposals, including development of process flow diagrams from process descriptions and development of a bill of materials

  • Support technical writing needs of the MS&T group

  • Select, integrate, evaluate and become subject matter experts of process equipment

  • Support acceptance testing and training on capital equipment

  • Support all MS&T team goals including covering other pipeline projects as necessary to achieve MS&T team goals

  • Develop protocols, execute and report experiments that determine evaluation of key and critical process parameters

  • Travel for person-in-plant (or lab) runs as required for process transfer and troubleshooting

  • Evaluate incoming processes for operability and develop risk assessment plans

  • Responsible for coordination of technical activities on assigned projects

  • Determine equipment requirements and capital expenditure budgets for projects

  • Independently perform review of process control parameters and testing protocols

  • Represents EBS to external customers, at conferences and/or organizations such as ISPE, PDA or ASME

  • 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.

  • Requirements:

  • Bachelor of Science degree in an engineering discipline with 4+ years of biologics drug substance manufacturing or development experience

  • Strong leadership skills; high level of personal/departmental accountability and responsibility.

  • Biologics manufacturing and/or technology transfer experience in one or more of the following areas:

  • Antibody therapeutics manufacturing

  • Viral or non-viral vaccine manufacturing

  • Microbial protein expression

  • Hands-on biologics expression of vaccines and/or therapeutics in industry

  • Ability to work collaboratively in multi-disciplinary teams

  • Excellent leadership, presentation, computer, and communication skills.

  • Experience using statistics software for process evaluation

  • Proficient with desktop software and basic programming experience

  • Experience with SAP or Equivalent ERP system

  • Experimental design experience

  • Experience with receiving and evaluating technology transfer data, development of bills of materials and evaluation of cGMP manufacturing suitability

  • Experience with writing SOPs, batch records, production protocols, deviation assessments, and technical reports

  • Experience with cGMP and/or EU regulations for biologics manufacturing

  • Experience with identifying, operating and evaluating process equipment

  • Joule, a System One division is a leader in specialized workforce solutions and integrated services. With more than 6,000 employees and roughly 50 offices throughout the U.S. we provide scientific, clinical, engineering, energy, IT, legal and administrative staffing services. For more than 40 years, we have delivered workforce solutions and integrated services to clients nationally.

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