Validation Engineer

Job Details:

Job Title: Process / Validation Engineer

Location: Branchburg, NJ

Duration: 12 Months

Tax Term: W2

Process / Validation Engineer

Prioritize a hands-on medical device process or validation engineer who has written validation protocols, executed them on the manufacturing floor, and documented the results. Equipment qualification experience (IQ/OQ/PQ) is particularly relevant. The manager explicitly said the team can teach cleaning validation to a medical device engineer with that foundation. Pharmaceutical manufacturing candidates are also eligible.

Location

100% onsite in Branchburg, NJ. Local candidates are preferred. The manager will consider candidates who relocate at their own expense and can commit to daily onsite work.

Education

Bachelor’s degree in engineering or a closely related field.

What the engineer will do

The team supports AlloDerm, a human tissue product. The immediate priorities are a process validation study in preparation for a pre-approval inspection targeted for the end of 2027, and cleaning validation studies addressing findings from an internal audit. The manager prefers medical device experience because the team is preparing for a planned transition of the product to medical device status.

The engineer will write protocols and final reports, execute studies on the floor with supervision, monitor production, and train operators on the procedures they need to follow after validation. Additional work includes equipment qualification, deviation investigations, CAPAs, change controls, and specification updates.

Priority

What to verify

1. Validation ownership

Ask for a study the candidate personally took from protocol writing through floor execution and final report. Look for specifics on what they measured, what happened during the run, and how they assessed the results.

2. Manufacturing and equipment qualification

Favor medical device engineers with hands-on IQ/OQ/PQ and production support. Pharma candidates with comparable validation experience are viable. Direct cleaning validation strengthens either profile.

3. OneVault and TrackWise

The manager emphasized these systems for controlled documents, deviations, and change control. Familiarity with both is strongest, and the manager indicated one of the two can be acceptable. Ask what records the candidate personally authored, routed, or investigated.

4. Operations handoff

Look for experience explaining a validated process to operators, training production personnel, or updating instructions after a study. The manager will train candidates who already cover most of the work.

5. Statistical tools

Minitab and statistical analysis experience are useful. The manager is flexible on these tools and willing to train.

Prescreen questions

1. Walk me through a validation study you personally wrote and executed. What did you do on the manufacturing floor, and what conclusion did you document in the final report?
2. Which IQ, OQ, or PQ activities did you personally perform? If you also worked on cleaning validation, what part of the study did you own?
3. How have you used OneVault or TrackWise? Describe one document, deviation, or change control you took through its workflow.
4. After a validation run, how did you prepare operators to execute the process routinely? Can you work onsite in Branchburg every day, and what is your earliest onsite start date?

What are the top 3-5 skills, experience or education required for this position:

1. BS of Engineering, Science, or closely related discipline w/ 2-3 yrs experience in Pharmaceutical or related

2. Experience with Cleaning Validation, Process Validation and Process Monitoring

3. Experience with I/O/PQ for equipment qualifications

4. Acknowledgeable with One-Vault, TrackWise, Microsoft PowerPoint and Statistical Software.

5. Support and monitoring Production as required to troubleshoot process and cleaning.

Job SUMMARY:

The Process Engineer II is responsible for providing 1st shift engineering production support including:

• Implementing process and technology improvements
• Regular on-the-floor manufacturing support
• Collecting, monitoring, analyzing, troubleshooting, and reporting manufacturing data related to performance in the areas of quality, cost, and speed/service to market
• Investigating non-conformances, CAPAs, process performance drifts and implementing corrective and preventative actions
• Conducting Technical assessments of change orders and Supplier Change Requests
• Responsible for the initiation and follow-through of the change control processes.

job QUALIFICATIONS (MINIMUM REQUIREMENTS):

The requirements described in this section are representative of those that must be met by an employee to successfully perform the essential functions of this job.

Education and Experience

• A Bachelors Degree in Engineering, science or closely related discipline is desired, or equivalent technical experience plus demonstrated competence, with a desired 2+ years of significant engineering and/or operational experience. Additional post-graduate education may contribute towards the desired years of experience.

Essential Skills, Experience, and Competencies (includes Licenses, Credentials)

• Experience with MS Office applications including Word, Excel & Outlook
• Demonstrated understanding and use of statistical methods in experiment design and data analysis
• Able to work independently and proactively in conjunction with all levels of the organization
• Experience with Quality System Regulations (QSR) and working in a medical device regulatory environment, generating manufacturing process documentation, FMEA and Risk Assessments, Design Control, Human Tissue Regulations, and Sterilization Validation Standards
• Six Sigma, Value Stream Mapping, Lean Manufacturing, Design for Manufacturability, DOE
• Biological Products and aseptic processes
• Development of robust manufacturing processes, validation, and process monitoring
• Experience with root cause analysis methods
• Experience with applications including Minitab or other statistical software, Microsoft PowerPoint, Project, and Visio.

Preferred Skills

• Time management skills and follow-through skills with the ability to work on and manage multiple tasks with tight deadlines.
• Strategic thinking and planning.

EEO:

“Mindlance is an Equal Opportunity Employer and does not discriminate in employment on the basis of – Minority/Gender/Disability/Religion/LGBTQI/Age/Veterans.”