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Title: Engineering Advisor
Hiring Organization: Connexion Systems & Engineering
Compensation, Benefits, and Employment Type
- Duration – Permanent
- Pay rate: 100-115K
- Job Location: Winslow, ME
- Job#: bh12295
As a member of a team dedicated to ensuring regulatory compliance for a network of vaccine manufacturing sites, the role will:
- Partner with external consultants to compare existing Establishment 196 practices (Outlines of Production, Batch records, work-instructions, control strategies, etc.) to current compliance requirements
- Develop a strategy (priority, timeline, owners, etc.) for improvements
- Actively execute the strategy after approval by executive leadership
- Periodically present progress to Executive Leadership
Though developing a strategy is a necessary component of this role, the focus is on the execution of the strategy—completing the improvements identified in the plan. This role will report to the manufacturing Site Head but will have significant exposure to executive leadership throughout the entire process.
Functions, Duties, Tasks:
- Partner with functional leaders, Site Head, external consultants, subject matter experts, and executive leadership to develop a compliance roadmap for the vaccine manufacturing site(s)
- Responsible for the execution and delivery of improvements through individual assignments and leading project teams
- Create, present, and lead training on improvements to processes or procedures
- Use technical skills to lead or participate in investigations, which may include change controls, deviations etc.
- Prepare protocols as needed and author Technical Reports to support the compliance roadmap
- Provide technical support through data analysis and trending
- Communicate progress to off-site steering team
- Replicate process for other vaccine manufacturing sites in the network
Minimum Qualification (education, experience and/or training, required certifications):
- Bachelor of Science degree in Engineering
- Experience with 9 CFR and USDA
- Strong interpersonal communication skills
- Demonstrated ability to execute complex projects
- Completion of Post Offer Exam, Completion of Work Simulation or Completion of Administrative Skills Testing if applicable.
- MS or PhD preferred
- Experience providing technical support in a manufacturing environment
- High level of technical troubleshooting ability in all engineering areas.
- Experience working in a team oriented, collaborative environment.
- Effective strategic, operational and management skills.
- Excellent communication, leadership, problem solving and analytical skills.
- Ability to rapidly adapt and respond to changes in environment and priorities.
- Ability to elicit cooperation from senior management and other departments
- Solid analytical and strategic capabilities and business acumen along with demonstrated work ethic, integrity, and professional conduct and appearance.
- Experience in Lean, Six-Sigma or Operational Excellence
- Proficiency with applicable computer systems, such as SAP, Veeva and Microsoft Office
- Travel may be required (not often)
PPE required in some working areas
Please use the apply button to submit your resume for consideration. A Connexion Representative will contact you immediately.
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