Manufacturing Engineer

Manufacturing EngineerThis 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.ResponsibilitiesDevelop, 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.Handle non-conformances, including investigation, documentation, and resolution 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.Communicate clearly in both written and verbal form with personnel from other departments to coordinate work and resolve issues.Provide recommendations on process improvements, procedures, and training based on validation findings and quality data.Prepare and maintain technical documentation, including validation protocols, reports, and supporting records.Apply quality and statistical tools to analyze data, troubleshoot issues, and support continuous improvement initiatives.Essential SkillsStrong 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 written and verbal communication skills for interacting with technical and non-technical stakeholders.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.S.) in Engineering.Minimum of 2 years of experience in validation within the pharmaceutical, biotechnology, or medical device industry.Additional Skills & QualificationsHands-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.Ability to mentor and cross-train colleagues to build broader validation capabilities within the team.Work EnvironmentThe 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. The environment is highly process- and documentation-driven, requiring careful attention to detail, thorough record-keeping, and adherence to established procedures and standards.Job Type & LocationThis is a Contract position based out of Warsaw, IN.Pay and BenefitsThe pay range for this position is $35.00 - $40.00/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 & visionCritical Illness, Accident, and Hospital401(k) Retirement Plan – Pre-tax and Roth post-tax contributions availableLife Insurance (Voluntary Life & AD&D for the employee and dependents)Short and long-term disabilityHealth Spending Account (HSA)Transportation benefitsEmployee Assistance ProgramTime Off/Leave (PTO, Vacation or Sick Leave)Workplace TypeThis is a fully onsite position in Warsaw, IN.Application DeadlineThis position is anticipated to close on Sep 23, 2026. Actalent