Process Engineer IV, Onsite

BioSpace; Branchburg Township (NJ); On-site; USD 90,000 - 120,000; Full time

Job summary

A leading company in the healthcare sector is seeking a Process Engineer IV to provide engineering production support. The role involves driving process improvements, ensuring business continuity, and developing expertise in manufacturing processes. Candidates should possess a technical degree and significant experience in a regulated environment.

Qualifications

• Experience in a regulated environment, preferably in a cGMP setting.
• 6+ years of experience with Bachelor's or 5+ years with Master's.
• Knowledge of Six Sigma, Lean Manufacturing, and statistical analysis.

Responsibilities

• Identify and drive process improvements to maximize performance.
• Provide regular manufacturing support and resolve process performance issues.
• Lead continuous improvement projects using Lean and Six Sigma methodologies.

Skills

MS Office

Statistical methods

Independent work capability

QSR

Medical device regulations

FMEA

Risk Assessments

Design Control

Sterilization validation

Six Sigma

Value Stream Mapping

Lean Manufacturing

DOE

Aseptic processes

Root cause analysis

Minitab

Education

Bachelor's degree in a technical field

Master's degree in a technical field

Job description

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Company Description

AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas: immunology, oncology, neuroscience, and eye care, as well as products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on X, Facebook, Instagram, YouTube, LinkedIn, and TikTok.

Job Description

The Process Engineer IV is responsible for providing engineering production support including:

• Identifying and driving process and technology improvements to maximize process performance.
• Ensuring business continuity by providing regular manufacturing support and prompt investigation and resolution of process performance drifts, CAPAs, and NCRs.
• Collecting, monitoring, analyzing, troubleshooting, and reporting manufacturing data related to quality, cost, and speed/service to market.
• Developing subject matter expertise in manufacturing processes through process changes, production improvement activities, and new product transfers.
• Initiating and following through on change control processes.

Support and monitor production to troubleshoot material, process, and equipment problems, including product loss and inefficiencies. Utilize technical abilities and experience, including structured analytical techniques and tools such as data acquisition, data analysis, process capability analysis, SPC, and other statistical tools.

40% Provide technical evaluations and support for Engineering Change Orders and Supplier Changes, including updates to specifications, drawings, procedures, and operator training.

30% Continuous Improvement Projects: Identify opportunities, propose projects, gain approval for resources, and lead initiatives using Lean and Six Sigma methodologies.

15% Design and develop equipment and processes for manufacturing, including in-house design or using vendor components. Design, build, and qualify fixtures, machines, or equipment.

10% Occasional travel to support continuous improvement initiatives, including external suppliers.

5% Additional responsibilities as assigned.

Qualifications

Experience in a regulated environment, preferably in a cGMP setting. Bachelor's degree in a technical field with 6+ years of experience or Master's degree with 5+ years. Preferably from an accredited engineering program.

Skills include proficiency with MS Office, statistical methods, independent work capability, and experience with QSR, medical device regulations, FMEA, Risk Assessments, Design Control, and sterilization validation. Knowledge of Six Sigma, Value Stream Mapping, Lean Manufacturing, DOE, and aseptic processes. Experience with root cause analysis, Minitab, and other statistical software.

Additional Information

Salary range and benefits are provided, with details on participation in incentive programs, benefits, and legal disclaimers.

Job Details

• Seniority level: Mid-Senior level
• Employment type: Full-time
• Job function: Management and Manufacturing