Manufacturing Engineer

Manufacturing Engineer

The Manufacturing Engineer is responsible for supporting process readiness, process and product transfers, engineering changes, equipment activities, validation execution, work instruction development, and manufacturing system implementation. This position ensures efficient and compliant site operations within a regulated production environment.

Responsibilities

• Own and review Engineering Change Requests (ECRs), Engineering Change Notices (ECNs), routers, Bill of Materials (BOM) updates, and work instructions.
• Walk processes to assess readiness, risks, and implementation needs.
• Support equipment installation, qualification (IQ/OQ/PQ), requalification, validation, relocation, and decommissioning activities.
• Support cleaning validation and cleaning process development, including criteria for residues and cleanliness, sampling and test method selection, cleaning agent evaluation, and periodic revalidation.
• Support packaging validation activities, including package integrity, seal strength and seal process validation, sterile barrier system qualification, distribution/transit simulation, shelf-life and aging studies, and labeling verification.
• Assist with protocol creation, execution support, deviation resolution, and report activities tied to transfers, validations, and manufacturing changes.
• Use Windchill to author, review, manage, and support engineering documentation and change activity.
• Own and execute InfoPV equipment qualification and validation activities, including protocol setup, documentation, execution support, record management, and traceability within the system.
• Develop, review, and maintain control plans, process flow diagrams, and pFMEAs to ensure manufacturing process consistency and compliance.
• Partner with Operations and Quality to improve flow, efficiency, and manufacturability.

Essential Skills

• Bachelor's degree in Mechanical, Biomedical, Manufacturing, Industrial, or related engineering field.
• Minimum of 35 years of manufacturing engineering experience in a regulated production setting.
• Demonstrated working knowledge of the InfoPV system, including equipment qualification documentation, execution, and traceability.
• Strong hands-on Windchill knowledge, including engineering documentation and change management (ECR/ECN, BOM, routers).
• Working knowledge of equipment qualification/validation processes and documentation (IQ/OQ/PQ, requalification).
• Experience with cleaning validation principles, acceptance criteria, and supporting documentation.
• Experience with packaging validation, including seal process validation, package integrity testing, and distribution/aging studies.
• Experience with process changes, documentation, and cross-functional implementation.

This role operates in a regulated production environment, requiring hands-on proficiency with systems such as Windchill and InfoPV. The work involves collaboration with cross-functional teams to ensure efficient and compliant manufacturing processes.

Job Type & Location

This is a Contract position based out of Warsaw, IN.

Pay and Benefits

The pay range for this position is $40.00 - $51.00/hr. Individual compensation offered for this position within this range will depend on many factors, including qualifications, skills, relevant experience, job knowledge, geographic location, internal equity, and other pertinent job-related factors.

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)

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 20,000 consultants and 5,000 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. We are proud to be an Engineering News-Record (ENR) Top 500 Design Firm for our engineering design services and a ClearlyRated Best of Staffing® winner for both client and talent service.

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 View email address on click.appcast.io for other accommodation options.

San Francisco Fair Chance Ordinance: Pursuant to the San Francisco Fair Chance Ordinance, for all positions located in the city and county of San Francisco, we will consider for employment qualified applicants with arrest and conviction records.

Massachusetts Lie Detector: It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

Use of Artificial Intelligence (AI): We may use Artificial Intelligence (AI) to support parts of our hiring process, including sourcing, screening, and evaluating candidates. AI helps assess applications and qualifications, but final decisions are made by our hiring team. By applying, you acknowledge and agree that your application may be reviewed using AI tools.