- 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.
- Establish and manage project schedules and timelines.
- Determine project resource requirements and works with stakeholders to Product 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. TrackWise, 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.
- 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.
- Strong understanding of Change Control and Project management
- Demonstrated ability to work both independently and as a part of a team.
- Strong technical problem-solving abilities.
- Demonstrated effective written and verbal communication skills.
- Strong collaboration skills
- Familiarity or experience with aseptic Vaccine Manufacturing Operations or Equipment
- Experience with introduction of process changes to a licensed process.
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Technical Operations Contractor - Lansdale, United States - Integrated Resources
Description
Job Title: Technical Operations ContractorJob Location: West Point, PA
Job Duration: 9+ Months
Payrate: $42/hour on W2
Job Description
Education Minimum Requirement: