3 Key Consulting, Inc.

Senior Process Engineer – Packaging Equipment, commercial GMP Final Drug Product operations (JP15195)

3 Key Consulting, Inc.  •  $45 - $50/hr  •  New Albany, OH (Onsite)  •  2 months ago
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Job Description

Job Title: Senior  Process Engineer – Packaging Equipment, commercial GMP Final Drug Product operations (JP15195)
Location: New Albany, OH. 43054
Employment Type: Contract
Business Unit: Process Development 
Duration: 18+ months with possible extensions and/or conversion to permanent
Posting Date: 3/6/2026
Pay Rate: $45 - $50/hour W2
Notes: Swing shift - candidates need to have flexibility for different shifts. Dayshift / Nightshift / Weekend. 10% travel required - Must be able to travel internationally for work (Europe/Canada)

3 Key Consulting is hiring an  Engineer for a consulting engagement with our direct client, a leading global biopharmaceutical company.

Ideal Candidate: Ideal Candidate: B.S. and 4 years of GMP experience, Packaging equipment experience, technical writing & Document management system experience - KNEAT or Veeva highly prefer.



The Senior Process Development Engineer – Packaging Equipment supports commercial GMP Final Drug Product (FDP) operations in New Albany, Ohio .

This is a technical leadership role requiring application of advanced engineering principles in equipment, devices, process optimization, and manufacturing support. The position requires on-site support and be able to work flexible schedule based on operation demands and both on-site work and ~10% travel

Key Functions & Outputs -

Project Management:

- Support technical transfer of product portfolio into the Ohio site.

- Drive continuous improvement in device assembly and packaging line capacity/performance.

- Communicate across the network to deliver technical milestones.

Technical Leadership:

- Act as site expert in automated/semi-automated device assembly.

- Lead commissioning, qualification, and validation (CQV) of GMP equipment.

- Own and maintain the site master validation plan.

Operational Excellence:

- Analyze, design, and implement manufacturing/business process improvements.

- Drive productivity, throughput, and efficiency gains.

Quality and Document Management Systems:

- Able to author and manage various documents/protocols/reports

- Deviation/CAPA/EV Owner

- Change Control Owner

Relationships:

- Build networks with commercial and clinical operations.

- Provide support for equipment standardization, troubleshooting, and performance trending

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

Why is the Position Open?

Planned project

Top Must Have Skills:
  1. 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
  2. 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
  3. 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
  4. 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
  5. Cross-Functional Collaboration

    Work with manufacturing, quality, engineering, and external vendors

    Coordinate with commercial and clinical teams

    Communicate progress on technical milestones and projects
  6. Project & Vendor Management

    Support equipment-related projects and timelines

    Interface with equipment suppliers/vendors for troubleshooting and improvements

    Contribute to standardization efforts across sites
  7. Flexible Operations Support

    Work swing shifts (day/night/weekend as needed)

    Provide support based on production demands

    Occasional travel (~10%)

Basic Qualifications:

Doctorate degree OR Masters degree and 2 years of experience OR Bachelors degree and 4 years of experience OR Associates degree and 8 years of experience OR High school diploma / GED and 10 years of experience

Red Flags:
1. Weak or No GMP Experience

2. Lack of Hands-On Equipment Experience

3. Poor Technical Writing / Documentation Skills

4. No Process Improvement Mindset

5. Limited Ownership or Leadership

6. Weak Communication & Cross-Functional Skills

7. Inflexibility with Schedule or On-Site Work

Interview process:

Virtual Interview, 2 rounds of interviews.

We invite qualified candidates to send your resume to  resumes@3keyconsulting.com  If you decide that you’re not interested in pursuing this particular position, please feel free to take a look at the other positions on our website www.3keyconsulting.com/careers. You are also welcome to share this opportunity with anyone you think might be interested in applying for this role
3 Key Consulting, Inc.

About 3 Key Consulting, Inc.

3Key Consulting specializes in the rapid recruitment and placement of business and IT professional within the life sciences and healthcare industries. With 12 years of experience, 3Key has established a vast network of industry professionals and forged strong partnerships/alliances with key academic institutions across the country to continually develop our business professional and niche skill pipeline.

3KC offers a full suite of staffing solutions including PEO and compliance services. 3KC has several technology and industry domain practices including competencies in business intelligence, healthcare and life sciences.

People, process, and technology are 3 key areas of focus that we carefully examine individually and jointly, in order to deliver on our client's 3 key areas of focus - better, faster and cost effective BI and staffing solutions.

MISSION:

To create a better work experience for our customers, partners and employees through exceptional dedication and performance.

• We make hiring easier

• We build strong teams

• We bring about positive outcomes

VISION:

3 Key Consulting’s responsibility is to continually improve the manner and efficiency in which human resources and businesses are brought together to create value. Our vision is to put programs into action that improve market efficiencies while helping businesses and people be more productive.

Industry
Unknown
Company Size
1-10 employees
Headquarters
Simi Valley, CA
Year Founded
2009
Website
3keyconsulting.com
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