Job Title: Manufacturing Engineer

Job Description

As a Manufacturing Engineer, you will support production to maintain inventory flow and levels to meet demand, work with Quality System regulations and requirements, and use your cGMP knowledge and understanding. You will address issues quickly and effectively, plan, lead, and execute complex cross-functional projects, and lead continuous improvement activities. Your role will also involve representing operations on new product development teams, analyzing product or equipment specifications, and performing technical communications on quality issues. You will lead the development and execution of equipment installation, operational qualifications, and process validations.

Responsibilities

• Support production to maintain inventory flow and levels to meet demand.
• Work with Quality System regulations and requirements (e.g., 21 CFR part 820, CFR Part 1271, 21 CFR Part 210/211, ISO 9001).
• Utilize cGMP knowledge and understanding.
• Address issues (e.g., NCR, CAPA) quickly and effectively.
• Plan, lead, and execute complex cross-functional projects impacting operations and other areas of the business.
• Lead continuous improvements activities of productivity, quality, cost, cycle time, and yield of raw materials.
• Lead efforts to maintain and improve quality of existing operations, processes, and products.
• Represent operations on new product development teams and develop and implement associated processes.
• Analyze product or equipment specifications and performance requirements to determine feasibility of new plant equipment or modifying existing equipment.
• Perform reporting duties for multiple interns and/or engineers.
• Provide analysis and recommendations for capital equipment investments.
• Act as a focal point for technical communications on quality issues.
• Utilize root cause analysis methods and statistical tools to resolve processing issues.
• Use statistical methods to determine in-control/out-of-control processes.
• Develop and implement methods and procedures for inspecting, testing, and evaluating products for acceptability.
• Lead the development and execution of equipment installation and operational qualifications.
• Lead the development and execution of process validations.
• Develop and maintain support systems for production work processes.
• Support the integration of new business work processes.
• Maintain the calibration program.

Essential Skills

• 0-2 years of engineering experience in Medical Device, Pharma, Tissue, or Bio-Medical Environment (5-7 years of experience is ideal).
• Bachelor’s Degree in Engineering.
• Strong understanding of biologics, Medical Device, Manufacturing, GD&T, QMS, ASQ, Six Sigma, tissue processing, nerve, validation, cGMP, GMP, Regulatory, Ppap, Quality management, Capa, Audit, root cause analysis, Commissioning, Manufacturing engineering, Process engineering, Process improvement.

Additional Skills & Qualifications

• Deviation and CAPA writing as well as implementation of small scale corrective projects.
• Pharmaceutical/GMP experience 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.

Work Environment

You will work in a new 70,000 sq ft building. The team environment is collaborative, and the dress code is business casual, with clean room requirements. The standard hours are 8 AM to 5 PM with a 40-hour work week, and occasional on-call responsibilities. The facility operates 24 hours a day, 5 days a week.

Pay and Benefits

The pay range for this position is $38.00 - $50.00/hr.

Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following:

• Medical, dental & vision
• Critical Illness, Accident, and Hospital
• 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available
• Life Insurance (Voluntary Life & AD&D for the employee and dependents)
• Short and long-term disability
• Health Spending Account (HSA)
• Transportation benefits
• Employee Assistance Program
• Time Off/Leave (PTO, Vacation or Sick Leave)

Workplace Type

This is a fully onsite position in Vandalia,OH.

Application Deadline

This position is anticipated to close on Feb 28, 2025.

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