Acts as the primary operations contact, overseeing manufacturing process design, documentation, and compliance. Serves as SME for technical content, managing risk assessments, change controls, and regulatory requirements. Collaborates with cross-functional teams and Capital Project stakeholders to ensure timely execution of automated packaging lines.
location: Pataskala, Ohio
job type: Contract
salary: $35.00 - 41.61 per hour
work hours: 9 to 5
education: Bachelors
responsibilities:
- Primary point of contact to support operations and the organization through planning, designing, creating manufacturing processes.
- Serve as the Subject Matter Expert (SME) for documentation, specifically responsible for initiating, revising, and/or approving technical content and manufacturing procedures (SOPs, WIs, Risk Assessments, Vendor URS, Protocols & Reports) to ensure all procedures reflect equipment design, regulatory requirements, and quality standards.
- Collaborate with the Capital Project team to develop and align on the project schedule and budget, managing the work plan, risks, and overall execution throughout the project lifecycle
- Provide impact and risk assessments for Change Control Review Board (CCRB) records as the change control owner. Contribute to equipment quality risk assessments (QRAES) and ensure proper manufacturing design and controls are in place.
- Collaborate with key cross-functional teams including, but not limited to, Engineering, Quality, Supply Chain, Product Development, Tech Transfer and NPI, and External equipment suppliers to ensure timely and accurate delivery of automated, high speed packaging manufacturing lines.
- Support the development of training materials for packaging procedures and equipment operations to ensure readiness for the packaging process.
- Manufacturing SME and point of contact to participate in regulatory inspections/audits.
qualifications:
Required:
- Bachelors and 3-5 years of manufacturing experience
- Packaging operations
- Process design, technical and engineering design
- Project management
- Experience creating and drafting SOP's, Work Instructions and pFMEA (Process Failure Mode effective analysis)
skills: GMP (Good Manufacturing Practice), Manufacturing Operations, Process Engineering
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.
At Randstad, 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 HRsupport@randstadusa.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, Randstad offers a comprehensive benefits package, including health, an incentive and recognition program, and 401K contribution (all benefits are based on eligibility).
This posting is open for thirty (30) days.
