Associate Technical Operations Contractor - West Point, United States - NavitsPartners

Description

Job Description

Position: Technical Operations Contractor - II (Associate)
Location: West Point, PA
Duration: 9 months

Job Summary:

The Technical Operations Contractor is responsible for providing technical support and executing projects within the commercial manufacturing area. This role involves actively supporting and embracing an empowered team culture, working independently, and potentially leading small teams or projects as required. The contractor will contribute to the department's performance and results and provide technical guidance, anticipating needs and implementing solutions.

Key Responsibilities:

• Project Management: Establish and manage project schedules and timelines, including determining project resource requirements and working with stakeholders to gain support from subject matter experts.
• Stakeholder Engagement: Maintain communication with stakeholders such as Operations, Quality, Regulatory, Analytical, and Process Development functions. Engage stakeholders in change control processes, risk escalation, and task execution.
• Change Control: Develop and execute change control procedures, including change definition, risk assessments, impact assessments, and support of associated regulatory filings.
• Technical Documentation: Author and update technical and manufacturing documents necessary for process design, engineering studies, process demonstrations, and validation.
• Experimental Protocols: Design and conduct experimental protocols using Technical Operations lab facilities or production equipment at full scale.
• Problem Solving: Examine issues from diverse perspectives (safety, compliance, automation, equipment, process, and people) to understand and resolve root causes.
• Standardized Work: Apply standardized work, engineering, and process tools (e.g., TrackWise, IPI, MS Project, Excel) consistently.
• Manufacturing Support: Provide technical support to manufacturing for problems and issues.
• Team Collaboration: Work as a team member to complete manufacturing investigations, process improvement, and/or validation projects.

Qualifications:

• Education: Bachelor's Degree in Engineering or Science.
• Experience: Minimum of two (2) years of work experience in the biological/pharmaceutical/chemical manufacturing industry.
• Knowledge: Familiarity with biologics, vaccine, or bulk sterile manufacturing facilities in process or validation support roles.
• cGMPs Knowledge: Minimum of six (6) months' work experience with cGMPs, Change Control, CFR, and other appropriate regulations for vaccine manufacturing.

Preferred Skills and Experience:

• Strong understanding of Change Control and project management.
• Demonstrated ability to work independently and as part of a team.
• Strong technical problem-solving abilities.
• Effective written and verbal communication skills.
• Strong collaboration skills.
• Familiarity or experience with aseptic vaccine manufacturing operations or equipment.
• Experience with introducing process changes to a licensed process.

Top Skillset:

• Project management skills to lead own small projects utilizing change control systems.
• Ability to lead and organize effectively with strong communication skills.
• Self-starter with initiative and the ability to work autonomously.