Engineer II - (Associate)

Yoh has a long term contract opportunity for an ENGINEER II - (ASSOCIATE) to join our client, a world leader in the pharmaceutical industry, located in WEST POINT, PA.

JOB RESPONSIBILITIES:

- Responsible for Batch Record Management -authoring, editing, and providing improvements to manufacturing execution instructions.
- Oversee Process Monitoring - analysing process derived data from various sources including Distributed control systems, Paper logs, and Laboratory databases.
- Review and assess trends in performance or data outliers.
- Identify and investigate outliers as necessary and preparing presentation of results.
- GMP Documentation - prepare various technical documents including testing protocols and reports.
- Provide documentation support for regulatory submissions including Prior Approval Supplements, initial BLA filings, PAI inspections, and Annual Reviews.
- Sample Management and coordination - coordinate with testing laboratories, ensuring on-time delivery and cold chain of custody for process analytical samples.
- Compile testing results and prepare closeout documentation for process demonstrations.

Job Qualifications:

- BA/BS Chemical Engineering, Biochemical Engineering, Biological Engineering or Biomedical Engineering, Mechanical Engineering or the Life Sciences
- Minimum of one (1) year experience in Vaccine, Biologic, or Pharmaceutical manufacturing or providing technical support of such processes.
- Experience with downstream purification unit operations such as tangential flow filtration or chromatography and distributed control systems such as DeltaV is preferred.
- Ability to work both independently and as part of a project team collaborating with members from Manufacturing/Operations, Technical Operations, Process Development, Validation, Automation and Quality.
- Experience authoring technical GMP documentation including batch records, standard operating procedures, protocols, change control, and/or validation reports.
- Demonstrated technical problem-solving, communication and collaboration skills.

Discover all that's possible with Yoh. Apply now.

Yoh is a professional staffing provider with over 70 years of experience in the short- and long-term staffing services industry; visit our website to learn both about our company and about our leading staffing solutions.

Yoh, a Day J2W: ENG

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