Job Description

***This is a 100% onsite position aligned ***'s Ohio location. Local candidates only, No relocations. Please confirm the candidate's location at the top of their resume***


Urgent role- Shortlisting EOD Wednesday 7/30


Hiring Manager Intake Notes:
• What location will this position be tied to?
*** Ohio (AOH)
• Will there be any opportunity for remote work?
This position is on-site
• What is the working environment for this role?
• IE office based, lab based, manufacturing floor?
Office based, manufacturing floor based
• What are the exact shift hours/schedule the contractor will be working/reporting? Regular shift hours (8am-5pm) Monday - Friday.
• Do you have a preference on time zone? The time zone would be Eastern Standard Time (EST)
• What type of qualities/characteristics are you looking for in candidates to work best with your team? Great Team player, Excellent communication qualities and critical thinking skills.
• When reviewing resumes, what stands out to you when looking for the right applicants? Relevant Experiences, Innovative/creative solutions, and proactive approaches.
• What is your minimum education and years of work experience you think it most suitable for this role? Bachelors and 3-5 years of experience in relevant areas.
• Need the candidate to be more focused on Technical Writing abilities, Creating and drafting SOP, WI (Work instruction), pFMEA (Process Failure Mode effective analysis/ Risk assessments) etc.
3-5 years of experience with these skills.
****Candidates must have experience with Manufacturing experience****


Role Summary:


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.


Description:
• 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.
• Actively participate in workshops pertaining to technology transfer/NPI process to assess requirements for documentation, materials, training, and equipment modifications.
• Manufacturing SME and point of contact to participate in regulatory inspections/audits.

Job Tags

For contractors, Work experience placement, Work at office, Local area, Remote work, Relocation, Shift work, Monday to Friday,

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