Technical Operations Contractor - II

Job Title

Pay Rate: 42/Hr Preferred

Experience and Skills:

Experience | Skills | Knowledge Required
• 3+ years in process automation or equivalent in pharmaceutical/ biotechnology industry.
• Familiarity with computer system validation and regulatory GXP requirements.
• Knowledgeable of S88 Batch Standard
• Strong communication and interpersonal skills to interface effectively with all levels of colleagues in a team environment, and with external parties.
• Technical and operational expertise in automation control systems such as Emerson DeltaV, AB PLC, Factory talk, SCADA, Windows operating systems, network infrastructure, SQL, etc.

Education Minimum Requirement:

• Bachelor's Degree in Engineering or Science Required

Experience and Skills:

• Minimum of two (2) years of work experience in the biological/ pharmaceutical/chemical manufacturing industry

• Experience in biologics, vaccine, or bulk sterile manufacturing facilities in a process or validation support role.

• Minimum of six (6) months' work experience with cGMPs, Change Control, CFR, and other appropriate regulations to vaccine manufacturing.

Responsibilities:

The Specialist is responsible for technical support and execution of projects in the commercial manufacturing area while actively supporting, participating in, and embracing an empowered team culture. In this role, the contracted person will work as an individual contributor, may act as a team or project lead and lead work of others as required, as well as contribute to the performance and results of a department.

Additionally, this individual will provide technical guidance and anticipate and interpret needs to identify and implement solutions.

Additional responsibilities include:

• Establish and manage project schedules and timelines
• Determine project resource requirements and works with stakeholders to gain support needed from subject matter experts. Stakeholders may include Operations, Quality, Regulatory, Analytical and Process Development functions.
• Responsible for stakeholder engagement, communication, and risk escalation.
• Develop and execute change control inclusive of change definition, risk assessments, impact assessments, task execution, implementation, and support of associated regulatory filings.
• Author/ update technical and manufacturing documents necessary for process design/ definition, engineering studies, process demonstrations, and validation.
• Design/conduct experimental protocols as needed using the Technical Operations lab facilities and/or production equipment at full scale.
• Examine an issue from diverse perspectives (safety, compliance, automation, equipment, process, and people) in order to best understand and resolve the root cause.
• Consistent application of standardized work, engineering, and process tools (i.e. Track Wise, IPI, MS Project, Excel).
• Provide technical support to manufacturing for problems and issues.
• Work as a team member on complete manufacturing investigations, process improvement and/or validation projects.