Computer Systems Validation Specialist III
Lonza · Portsmouth, NH
- Level
- Senior
- Team
- Quality
- Degree
- Required
- Experience asked
- 3+ years
- Industry
- Pharma & life sciences
- Posted
- 30+ days ago
The role in 30 seconds
A senior quality role at Lonza (pharma & life sciences) in Portsmouth, NH.
- They ask for
- 3+ years · degree required
- Tools it names
- FDA / GMP, Validation (IQ/OQ/PQ)
- Day to day
- relocation help
Read from the posting. The full description is below.
From the plant jobs report · week of October 19, 2026
Quality Engineer roles in New Hampshire: typical posted base $97k–$165k.
Median of the low and high ends of 15 live postings that list pay, out of 39 quality engineer openings in New Hampshire, read from manufacturers' own careers sites.
New Hampshire plant jobs report →Pay by team and state →What moves pay →
How this role compares
Against 38 other live quality postings in New Hampshire.
- Base pay
- Not listed in this posting
- Experience asked
- Less than usual (3+ vs 5+)
Typical $97k–$165k, from 15 postings that list pay.
Similar roles usually ask 5+ years.
Skills these teams ask for most
- Root cause 72%
- Lean 46%
- Six Sigma 44%
- Supplier quality 41%
- AS9100 38%
- ✓ FDA / GMP 38%
✓ = this posting asks for it too. % = share of similar postings that mention it.
At a glance
Pulled from the posting text. If it's not listed here, the posting didn't say.
How to get in at this plant
Five moves over a week or two. The first one takes ten minutes.
- 1
Pick 2–3 people on the Quality team at Lonza
Engineers who joined in the last year or two reply the most. Use the team search on this page to find them.
- 2
Send a short, curious note
One real question about their work. No favors yet. Each person gets a different note, written for this role.
- 3
Turn a reply into a short call
Questions worth asking about this team:
- What does a normal week look like on your team?
- Which standards drive the work here: ISO 13485, IATF 16949, AS9100?
- How much of the job is customer complaints versus prevention?
- How did you land the job? What stood out in your interviews?
- 4
Apply with someone vouching for you
If the call went well, ask whether they’d pass your résumé to the hiring manager. Send your résumé link, apply that day, and let them know.
- 5
Bring proof to the interview
One page of before-and-after numbers from projects you led: scrap, OEE, cycle time, cost. Plant managers hire on results.
This plant: Lonza in Portsmouth
16 other open roles at this site.
- Manufacturing Manager · Manufacturing · Manager
- QA Specialist II - Operations · Quality · Specialist
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- Manufacturing Supervisor · Manufacturing · Supervisor
- MSAT Process Engineer/Scientist III - Downstream · Process · Senior
- Facilities Suite & Elastomer Maintenance Mechanic, Level III (Night Shift) · Reliability · Technician
Full description from LonzaAs posted on their careers site.ShowHide
What you will do
- ◆Perform all aspects of QMS process’ – Change Control, Deviations,
- ◆CAPAs.
- ◆Perform Gap assessments to identify the gaps in processes and suggest remediation plans. Initiate the right Quality records (Deviations and CAPAs) to drive the remediation plan, as needed and execute all
responsibilities
as CSV project lead for projects.
- ◆Author/Review/Approve all end to end Computer system validation life-
- ◆cycle deliverables/activities.
- ◆Schedule qualification activities and personnel to meet business,
- ◆manufacturing, engineering and quality objectives.
- ◆Revise and maintain SOPs to ensure continuous improvement and
- ◆compliance to GROUP/CORP procedures.
- ◆Perform review of Engineering documents (P&IDs, SOPs, Specifications, Submittals, etc.).
- ◆Support Validation requests as a CSV SME, during Customer audits and inspections.
Show full description ↓Show less ↑
Computer Systems Validation Specialist III
Location: Portsmouth, NH. Relocation assistance is available for eligible candidates and their families, if needed.
The Computer Systems Validation (CSV) Specialist III leads teams in assessing new and changing computer systems to ensure compliance with company policies and industry guidance. They conduct risk assessments, review change requests and test scripts, draft protocols, and oversee GMP documentation revisions. This role acts as the QA CSV representative for small and large-scale projects while providing technical guidance and mentorship to junior team members.
What you will get
- •A collaborative and inclusive work environment.
- •Opportunities for career growth and development.
- •Access to cutting-edge technologies and tools.
- •Competitive compensation and benefits package.
- •401(k) matching plan.
- •Supportive leadership and mentoring.
- •Commitment to ethical and sustainable practices.
Our full list of global benefits can be found here: https://www.lonza.com/careers/benefits .
What we are looking for
- •Bachelor’s degree in computer science, engineering, or related field.
- •At least 3+ years of experience in computer systems validation.
- •3+ years of Experience in working in a cGMP facility.
- •Experience with 21 CFR Part 11 and ISPE GAMP guidelines as they relate to Computer.
- •Systems Validation (especially for analytical computerized systems).
- •Works independently and in teams.
- •Background in biotech, pharma, or medical device industry.
- •Ability to work independently and on-site in Portsmouth NH.
About Lonza
At Lonza, our people are our greatest strength. With 30+ sites across five continents, our globally connected teams work together every day to manufacture the medicines of tomorrow. Our core values of Collaboration, Accountability, Excellence, Passion and Integrity reflect who we are and how we work together. Everyone’s ideas, big or small, have the potential to improve millions of lives, and that’s the kind of work we want you to be part of.
Innovation thrives when people from all backgrounds bring their unique perspectives to the table. At Lonza, we offer equal employment opportunities to all qualified applicants regardless of race, religion, color, national origin, sex, sexual orientation, gender identity, age, disability, veteran status, or any other characteristic protected by law. If you’re ready to help turn our customers’ breakthrough ideas into viable therapies, we look forward to welcoming you on board.
Ready to shape the future of life sciences? Apply now.