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Technical Operations Contractor - II (Associate)

Company:
LanceSoft Inc.
Location:
Elkton, Virginia, United States
Posted:
April 10, 2019

Description:

Responsibilities:

"GENERAL SUMMARY:

The Specialist, Technical Operations, is responsible for providing technical support to three bulk areas through lab-scale process experimentation for process optimization, and investigational support while actively supporting, participating in and embracing an empowered team culture.

GENERAL PROFILE:

• Functioning as a key member of the technical services lab team through executing lab-scale process optimization, and investigation support for cell culture and downstream processing.

• Perform tissue culture based experiments on live vaccine products, and intermediates

• Prepare culture media and solutions

• Functioning as a key team member to collaborate with bulk manufacturing teams to support area objectives.

• Maintain records and test results following good manufacturing practices (GMP)

• Executing assignments against critical-path timelines in a right-first-time manner.

• Authoring technical documents to support process optimization and investigation support.

• Participating in technical support activities for licensed vaccines, as needed.

• Anticipates and interprets client and/or customer needs to identify and implement solutions.

BUSINESS EXPERTISE:

• Applies technical skills to align activities with department objectives.

FUNCTIONAL EXPERTISE:

• Leads and/or works independently as a team member on manufacturing investigations, validation and/or process improvement projects.

• Has ability to examine an issue from diverse perspectives (safety, compliance, automation, equipment, process, and people) in order to best understand and resolve the root cause.

• Conducts and Design experimental protocols

PROBLEM SOLVING:

• Identifies and resolves technical and operational problems using lean/six sigma tools.

• Effectively collaborates with peers on site and above site as required.

• Resolves non-routine issues appropriately using standard procedures for guidance.

IMPACT: Influence

• Effectively communicates both verbally and written. Accountability

• Accountable for the individual performance.

• Strong attention to detail Decision Making

• Makes decisions – guided by policies, procedures and department objectives.

• Consults on an as-needed basis with next-level manager on more complex decisions."

Qualifications:

Title: Technical Operations Contractor Location: Position will be West Point, PA

QUALIFICATIONS: A. Essential:

• B.S. degree in Engineering or Sciences.

• Minimum of one (1) year of relevant manufacturing/laboratory experience

• Communication, leadership and teamwork skills.

• Ability to work weekends and overnight hours as needed B.

Preferred:

• Experience in biologics, vaccine or bulk sterile GMP manufacturing facilities.

• Six Sigma certification.

• Experience managing multiple tasks simultaneously, including leading small projects.

WORKING RELATIONSHIPS:

Reports to Technical Operations Manager.

Interacts with employees within own department and from other departments.

May interact with representatives from regulatory agencies.

May interact with external suppliers.