We are seeking a Manufacturing Engineer for an onsite, 12-month contract position. You will collaborate directly with machine operators on the production floor and work with manufacturing machinery such as Swiss lathes, turning machines, grinding machines, cleaning machines, and mills (including Haas, Makino, and Elma).
Responsibilities:
...
Process & Equipment Validation: Follow, refine, and develop processes and process validation plans. Support a wide variety of equipment qualifications, including CNC machines.
Document & Change Management: Direct the development, execution, and management of installation, qualification, and validation documents and protocols, including IQ/OQ/PQ documentation. Create change requests in Windchill to support equipment moves.
Daily Planning & Collaboration: Devise daily work plans based on communication with maintenance, quality, engineering, and management teams. Effectively work within cross-functional teams to complete critical project tasks.
Team Leadership: Guide, mentor, and cross-train team members to broaden validation capabilities across equipment and processes. Project Execution: Independently develop and execute project plans and schedules for work activities.
Working hours: 7:00 AM - 3:00 PM
Skills:
Degree: B.S. in Engineering.
Industry Experience: A minimum of 3 years of experience in validation within pharmaceutical or biotech manufacturing.
Education:
Bachelors
Experience:
1-4 years
Qualifications:
Education & Experience Baseline: Must meet at least one of the following equivalent qualification levels:
Bachelor's Degree with 0 years of relevant experience. Associate's Degree with 2 years of relevant experience.
High School Diploma or Equivalent with 4 years of relevant experience.
Technical Knowledge: Familiarity with G and M code, though no programming is required.
Validation & Qualification: Direct experience with process validation, equipment qualification, and Gauge R&R. Proficiency with the validation of manufacturing equipment, utilities, cleaning processes, and computer systems. Regulatory Competence: Strong knowledge of cGMP regulations, including FDA, EMA, and ISO requirements.
Analytical Skills: Good problem-solving skills through the use of quality and statistical tools. Communication: Demonstrated strong written, verbal, technical writing, and documentation skills.
Apply today! Send your resume to Spherionprofessionals-dl@spherion.com for immediate consideration!
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Spherion has helped thousands of people just like you find work happiness! Our experienced staff will listen carefully to your employment needs and then work diligently to match your skills and qualifications to the right job and company. Whether you're looking for temporary, temp-to-perm or direct hire opportunities, no one works harder for you than Spherion.
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At Spherion, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact Callcenter@spherion.com.
Pay offered to a successful candidate will be based on several factors including the candidate's education, work experience, work location, specific job duties, certifications, etc. In addition, Spherion offers a comprehensive benefits package, including: medical, prescription, dental, vision, AD&D, and life insurance offerings, short-term disability, and a 401K plan (all benefits are based on eligibility).