Process Engineer specializing in biogas projects, leading technical decisions and analyses. Involved from preliminary studies to basic project development in São Paulo, Brasil.
About the role
- Project Engineer III managing Engineering activities for pharmaceutical manufacturing projects at Leiters Health. Collaborating with teams, ensuring compliance, and leading project execution in a cGMP environment.
Responsibilities
- Manage site activities necessary for successful execution of project(s) and ensure these are completed as necessary to tie in with the overall project execution.
- Ensure all company and site Engineering policies and procedures are adhered to.
- Ensure all work carried out and equipment installed is safe, effective and compliant with industry standards.
- Ensure all work undertaken is reflected accurately in up-to-date Engineering, project and Maintenance files.
- Report project status to the VP, Engineering, project team members, project management personnel, and functional stakeholders.
- Serve as liaison between professional Engineering firm(s), maintenance team members, construction firms, service firms, and site project team members involved in the project(s) at hand.
- Manage and resolve technical issues or changes arising throughout production equipment life cycle while also ensuring the overall production schedule, equipment performance, and budgeted cost to maintain are adhered to.
- Ensure all new or modified equipment, facilities, and utilities are handed over effectively to end users.
- Apply engineering expertise toward the development and continuous improvement of departmental toolsets, such as operational procedures, design specifications, and whitepapers.
- Perform any other activities as directed by the VP, Engineering.
- Leads consistently in productivity, quality and teamwork metrics.
- Adheres to all applicable procedures, cGMPs, company policies and any other quality or regulatory requirements. (For example: OSHA, DEA, FDA, EMEA, EHS, etc.)
- Provide training and development oversight to support the growth of new or junior engineers.
Requirements
- Bachelor’s degree required; technical degree preferred.
- 5 years minimum experience in managing facilities for a cGMP FDA regulated pharmaceutical manufacturing environment; 2 or more years aseptic processing facility preferred.
- Knowledge of cGMP guidelines/standards.
- Advanced problem solving such as Six Sigma and Lean training, Green Belt or Black Belt preferred.
- Project Management experience required.
- Experience in managing capital projects with a focus on aseptic focused filling equipment preferred.
- Strong results orientation.
- Excellent matrix management skills and organizational skills.
- Proficient in Microsoft Office products including Project, Outlook, Excel, and Word.
- Proficient written, verbal and oral English communication skills are required.
Benefits
- Smart healthcare coverage options that rewards wellness (and puts money back in your pocket!)
- Flexible Spending & Health Savings Accounts (FSA & HSA) available
- Dental & Vision insurance
- Employer Paid Life Insurance & Employee Assistance Program
- Short Term & Long-Term Disability Insurance
- Up to 4% 401K Matching (100% vested on day one!)
- Generous Paid Time Off Options – vacation, sick, paid leave and holidays!
- $5,250 Annual Tuition Reimbursement after 6 months
- $1,000 Referral Bonus Program with no limit
- Eligible for annual bonus program
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