Engineer Senior

Job description

Payrate:

$40.00 - $43.00/hr.

Responsibilities:

Equipment & Manufacturing Support:

Provide on-site support for GMP packaging and device assembly operations Troubleshoot equipment issues and improve reliability/performance Support automated and semi-automated assembly lines Monitor and trend equipment performance metrics

Process Improvement & Optimization:

Identify and implement process improvements to increase throughput and efficiency Analyze manufacturing data to drive continuous improvement initiatives Optimize packaging line capacity and performance

Documentation & Quality Systems:

Write, review, and manage GMP documents (protocols, reports, procedures) Own and manage deviations, CAPAs, and change controls Maintain and update the site master validation plan Use systems like KNEAT or Veeva for document control Validation & Technical Projects (CQV): Lead or support commissioning, qualification, and validation (CQV) activities Support tech transfer of products into the Ohio site Ensure equipment and processes meet regulatory and quality requirements

Cross-Functional Collaboration:

Work with manufacturing, quality, engineering, and external vendors Coordinate with commercial and clinical teams Communicate progress on technical milestones and projects

Project & Vendor Management:

Support equipment-related projects and timelines Interface with equipment suppliers/vendors for troubleshooting and improvements Contribute to standardization efforts across sites

Qualifications:

Basic (Education & Experience) Doctorate (no experience required) OR Master's + 2 years GMP experience OR Bachelor's + 4 years GMP experience OR Associate's + 8 years GMP experience OR High School/GED + 10 years GMP experience

Preferred:

Combination product assembly equipment expertise Cross-functional project leadership experience Strong teamwork and communication skills Direct experience in devices, combination products, and packaging operations Supplier management experience (FDP equipment vendors) Adaptability in regulated, fast-paced environments Operational excellence / continuous improvement mindset Top 3

Must Have Skill Sets:

GMP & Packaging Equipment Expertise:

Strong hands-on experience in GMP-regulated environments Direct experience with packaging / device assembly equipment (automated or semi-automated) Involvement in commissioning, qualification, and validation (CQV)

Technical Writing & Document Management Systems:

Proven ability to author and manage GMP documents (protocols, reports, validation docs) Experience with document management systems (preferably KNEAT or Veeva) Ownership of deviations, CAPAs, and change controls

Process Development & Continuous Improvement:

Ability to analyze and optimize manufacturing processes Experience driving efficiency, throughput, and performance improvements Strong technical leadership in process/equipment optimization Strong project management and team player skillset. Ability to work within different cross functional groups and coordinate projects.

Nice to have:

Kneat/Veeva and Former experience managing projects

Pay Transparency:

The typical base pay for this role across the U.S.

is:

$40.00 - $43.00 /hr. Non-exempt positions are eligible for overtime at a rate of 1.5 times the base hourly rate for all hours worked in excess of 40 in a work week, or as required by state or local law. Final offer amounts, within the base pay set forth above, are determined by factors including your relevant skills, education and experience. Full-time employees are eligible to select from different benefits packages. Packages may include medical, dental, and vision benefits, health savings accounts with qualified medical plan enrollment, 10 paid days off, 3 days paid bereavement leave, 401(k) plan participation with employer match, life and disability insurance, commuter benefits, dependent care flexible spending account, accident insurance, critical illness insurance, hospital indemnity insurance, accommodations and reimbursement for work travel, and discretionary performance or recognition bonus. Sick leave and mobile phone reimbursement provided based on state or local law. Consent to

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