Manufacturing Engineering Manage

Manufacturing Engineer

This Manufacturing Engineer role focuses on developing, executing, and managing installation, qualification, and validation documentation and protocols for process equipment in a regulated manufacturing environment. The position supports a wide range of equipment qualifications, including CNC machines, and plays a key role in ensuring compliance with cGMP regulations and quality management system requirements. The engineer will collaborate closely with cross-functional teams, lead validation activities, and provide technical guidance to enhance equipment and process validation capabilities.

Develop, execute, and manage installation, qualification, and validation documents and protocols for process equipment.

Support a wide variety of equipment qualifications, including CNC machines and related manufacturing equipment.

Guide, mentor, and cross-train team members to expand equipment and process validation capabilities.

Create and manage change requests in Windchill to support equipment moves and related configuration changes.

Execute project plans and schedules to ensure timely completion of validation and engineering activities.

Conduct Issue Evaluations and support the implementation and closure of Corrective and Preventive Actions (CAPAs).

Collaborate effectively with cross-functional teams to complete critical project tasks and validation deliverables.

Provide recommendations on process improvements, procedures, and training based on validation findings and quality data.

Apply quality and statistical tools to analyze data, troubleshoot issues, and support continuous improvement initiatives.

Strong knowledge of current Good Manufacturing Practice (cGMP) regulations, including FDA and EMA requirements.

Experience writing and executing validation protocols and reports, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) documentation.

Proficiency in validation of manufacturing equipment, utilities, cleaning processes, and computer systems.

Good problem-solving skills using quality and statistical tools to identify root causes and implement effective solutions.

Ability to work effectively within cross-functional teams to complete critical project tasks and validation activities.

Strong technical writing and documentation skills for authoring protocols, reports, and supporting documentation.

Ability to independently develop and execute project plans and manage multiple tasks in a regulated environment.

Demonstrated ability to take initiative and provide recommendations on processes, procedures, and training needs.

Working knowledge of Quality Management Systems, including Nonconformance and Issue Evaluation processes.

Experience in manufacturing engineering with focus on equipment qualification and quality management systems.

Bachelor of Science (B.in Engineering.

Minimum of 2 years of experience in validation within the pharmaceutical, biotechnology, or medical device industry.

Hands-on experience with CNC machines and related manufacturing equipment in a regulated environment.

Experience in manufacturing engineering supporting equipment qualification and process validation.

Familiarity with medical device manufacturing practices and regulatory expectations.

Experience using Product Lifecycle Management (PLM) tools such as Windchill to manage change requests.

Exposure to utilities and cleaning process validation in pharmaceutical or biotech operations.

Comfort working with statistical and quality tools to support validation and continuous improvement projects.

The role operates in a regulated manufacturing and engineering environment that supports pharmaceutical, biotechnology, or medical device production. The Manufacturing Engineer works closely with cross-functional teams such as quality, production, and maintenance while supporting equipment qualification activities, including CNC machines and other process equipment. The position involves frequent interaction with electronic documentation systems, Quality Management Systems, and tools such as Windchill for managing change requests. Work typically follows structured project plans and validation schedules, with a strong emphasis on compliance with cGMP, FDA, and EMA requirements. This is a Contract position based out of Warsaw, IN.

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.

If eligible, the benefits available for this temporary role may include the following:

• Medical, dental & vision
• 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)
• Employee Assistance Program
• Application Deadline This position is anticipated to close on Sep 23, 2026. 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.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 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.