Engineering Specialist Job Description Template
Our company is looking for a Engineering Specialist to join our team.
Responsibilities:
- Work with production, automation and project engineering groups on process improvement projects;
- Support the day to day activities of the project from inception through engineering, construction, commissioning and hand over;
- Develop construction prints detailing facilities to be removed/installed;
- Authoring notifications to applicable Health Authorities, in response to deviations or complaints, as required;
- Identify and initiate process improvements in conjunction with the Project Engineering team;
- Report the progress of the project to the senior engineer as needed;
- Support continuing validation for cleaning/sterilization processes;
- Identifies spare parts and stand-by equipment needed to assure maximum capacity and reliability;
- Author and updates technical and manufacturing documents to support process changes, investigations, engineering/demonstration work, and validations;
- Assist in audits, regulatory inspections and training in the area of responsibility;
- Become proficient at multiple client programs;
- Author technical reports and manufacturing batch records;
- Review project scope and identify issues early on;
- Participating in technical support activities for licensed vaccines;
- Executing assignments against accelerated, critical-path timelines in a right-first-time manner.
Requirements:
- Fermentation/cell culture experience;
- Familiarity with Vaccine Manufacturing Operations;
- Experience with presenting to an internal /regulatory auditor;
- Large molecule manufacturing and on-the-floor manufacturing support;
- Advanced knowledge of Excel, Minitab, JMP, and/or S-plus;
- Follow written operating procedures;
- Bachelors Degree in Chemical Engineering, Mechanical Engineering, Biochemistry, or similar science/engineering discipline;
- Write operating procedures, train employees, and perform needed validation of procedures;
- Maintain proper Good Manufacturing Practices, Good Documentation Practices, and Workplace Contamination Rules compliance;
- Minimum of 2 years of experience in a GMP-related environment;
- Must be able to work both independently and within multi-functional teams in a fast-paced environment;
- Familiarity with cGMPs, CFR, and other appropriate regulations in relation to vaccine manufacturing;
- Working knowledge of cGMPs and of regulatory requirements as they apply to the vaccine/pharmaceutical industry;
- Experience with formal problem-solving techniques and a hands-on approach to problem-solving, such as root cause analysis and/or Lean Six Sigma tools;
- Set-up and operate BFS machines and support equipment to produce bottled sterile solutions.