What are the responsibilities and job description for the Manufacturing Engineer position at Actalent?
Description:
- Supports production to maintain inventory flow and levels to meet demand
- Working with Quality System regulations and requirements (ie 21 CFR part 820, CFR Part 1271, 21 CFR Part 210/211, ISO 13485, ISO 9001, ISO 14971)
-Using cGMP knowledge and understanding
- Addressing issues (e.g. NCR, CAPA) quickly and effectively
- Plans, leads, and executes complex cross functional projects impacting operations and other areas of the business
- Leads continuous improvements activities of productivity, quality, cost, cycle time and yield of raw material
- Leads efforts to maintain and improve quality of existing operations, processes, and products
- Represents operations on new product development teams. Develops and implements associated processes.
- Analyzes product or equipment specifications and performance requirements to determine feasibility of new plant equipment or modifying existing equipment
- May include reporting duties for multiple interns and/or engineers
- Analysis and recommendations for capital equipment investments
- Being a focal point for technical communications on quality issues
- Utilizing root cause analysis methods and statistical tools to resolve processing issues.
- Using statistical methods to determine in-control/out-of-control processes.
- Developing and implementing methods and procedures for inspecting, testing and evaluation of products for acceptability
- Leads the development and execution of equipment installation and operational qualifications.
- Leads in the development and execution of process validations.
- Leads in developing and maintaining support systems for production work processes
- Supporting integration of new business work processes
- Maintenance of the calibration program
Skills:
Bio Med, Quality, Pharma, Manufacturing process, Biomedical, continuous improvement, biologics, Medical Device, Manufacturing, GD T, QMS, ASQ, Six Sigma, tissue, tissue processing, nerve, validation, cGMP, GMP, Regulatory, Ppap, Quality management, Capa, Audit, root cause analysis, Commissioning, Manufacturing engineering, Process engineering, Process improvement, CFR Part, fda compliance
Additional Skills & Qualifications:
- Deviation and CAPA writing as well as implementation of small scale corrective projects
- Pharmaceutical/GMP or other similar regulated industry with small scale project management skills
- Degree in Biomedical Engineering is a plus
- Ability to troubleshoot and work on PLCs
- Experience in Manufacturing Engineering, Process Design Engineering, Process Optimization, or Process Development preferably with a regulated medical product.
- Proven project leadership / management skills
- Lean manufacturing and/or process controls experience a plus.
- Willingness to process and handle human and animal tissue based products,
About Actalent
Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.
Diversity, Equity & Inclusion
At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:
- Hiring diverse talent
- Maintaining an inclusive environment through persistent self-reflection
- Building a culture of care, engagement, and recognition with clear outcomes
- Ensuring growth opportunities for our people
The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.
If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.
Salary : $38 - $50
