Mandatory Skills
- 7+ years of Packaging Engineering experience
- Medical device, pharmaceutical, healthcare, or regulated manufacturing experience
- Packaging process development, improvement, equipment qualification
- IQ/OQ/PQ and packaging process validation
- Root Cause Analysis (RCA), CAPA, FDA/quality system compliance
- Lean Manufacturing / Six Sigma and cross-functional collaboration
Job Description
Kindly share profiles for the following requirement:
Job Title: Sr Packaging Engineer
Client: Will share shortly
Location: North Haven, CT
Work Arrangement: Onsite
Visa: USC
Experience Level: 7+
Bill Rate: $45/hr
Responsible for supporting and improving packaging operations for medical device manufacturing. Lead packaging process development, equipment qualification, and validation activities (IQ/OQ/PQ).
Collaborate with Manufacturing, Quality, Regulatory, Operations, and Engineering teams to resolve production issues, implement continuous improvement initiatives, and ensure compliance with FDA and quality system requirements.
Perform root cause investigations, develop CAPA solutions, maintain technical documentation, support packaging equipment and process validation, and drive operational excellence using Lean Manufacturing and Six Sigma methodologies. Strong problem-solving, project leadership, technical communication, and cross-functional collaboration skills are required.
Qualification
Bachelor's Degree in Packaging Engineering, Packaging Science, Mechanical Engineering, Chemical Engineering, or related Engineering discipline.
7+ years of Packaging Engineering experience (or equivalent advanced degree and relevant experience).
Experience in Medical Device, Healthcare, Pharmaceutical, or other regulated manufacturing environments preferred.
Knowledge of packaging validation, manufacturing processes, quality systems, and regulatory requirements.
Relevant Industries
- Medical Device / Healthcare / Pharma / Regulated Manufacturing
Priority
- 7+ years of Packaging Engineering
- Medical Device / regulated manufacturing experience
- Packaging Process Development & Improvement
- IQ/OQ/PQ & Packaging Validation
- Root Cause Analysis & CAPA
- FDA / Quality System requirements
- Packaging equipment qualification
- Lean Manufacturing / Six Sigma
- Strong cross-functional collaboration
Nice to Have
- Direct FDA-regulated packaging environment
- Continuous improvement / Operational Excellence
- Experience with packaging equipment troubleshooting
What to Look for on Resume
Packaging Engineering + Medical Device + IQ/OQ/PQ + Validation + CAPA + Root Cause + FDA/Quality Systems + Lean/Six Sigma
Do Not Consider
- Less than 7 years of relevant Packaging Engineering
- General Mechanical/Chemical Engineers with no packaging experience
- Consumer packaging-only profiles with no regulated manufacturing
- No validation/qualification experience
- No medical/pharma/regulated manufacturing exposure
- Unable to work onsite in North Haven, CT
Education & Experience
Bachelor's in Packaging Engineering, Packaging Science, Mechanical, Chemical Engineering, or related
7+ years of Packaging Engineering experience
Advanced degree may substitute for some experience if relevant
Screening Questions
- How many years of Packaging Engineering experience do you have?
- Do you have Medical Device/Pharma/Healthcare packaging experience?
- Describe your experience with IQ/OQ/PQ and packaging validation.
- Have you worked with packaging equipment qualification/troubleshooting?
- Experience with CAPA and Root Cause Analysis?
- What experience do you have with FDA/Quality Systems/regulated manufacturing?
- Do you have Lean Manufacturing or Six Sigma experience?
- Are you comfortable working onsite in North Haven, CT?