Computer Systems Validation Engineer
Lonza · Portsmouth, NH
- Level
- Engineer
- Team
- Quality
- Degree
- Required
- Experience asked
- 5+ years
- Industry
- Pharma & life sciences
- Posted
- 30+ days ago
The role in 30 seconds
An engineer-level quality role at Lonza (pharma & life sciences) in Portsmouth, NH. Own, revise and maintain computer systems validation SOPs (Standard Operations Procedures).
- They ask for
- 5+ years · degree required
- Tools it names
- FDA / GMP, Validation (IQ/OQ/PQ), Automation, MES
- Day to day
- relocation help
Read from the posting. The full description is below.
How this role compares
Against 37 other live quality postings in New Hampshire.
- Base pay
- Not listed in this posting
- Experience asked
- Typical (5+ years)
Typical $97k–$165k, from 15 postings that list pay.
Similar roles usually ask 5+ years.
Skills these teams ask for most
- Root cause 71%
- Lean 47%
- Six Sigma 45%
- Supplier quality 42%
- AS9100 39%
- ✓ FDA / GMP 37%
✓ = this posting asks for it too. % = share of similar postings that mention it.
Stands out: this posting asks for MES, which few similar roles mention. If you have it, lead with 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
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Full description from LonzaAs posted on their careers site.ShowHide
What you will do
- ◆Lead efforts between internal customers and CSV to ensure assigned activities are prioritized, communicated in an effective and timely manner, and completed on time.
- ◆Accountable for maintaining full knowledge of Lonza's policies/procedures, 21 CFR Part 11, Data Integrity, ICH Q7A
requirements
and GAMP and the underlying principles of each.
- ✓Perform all aspects of Quality Systems Management (QSM) processes (Change Control, Deviation, Corrective and Preventable Actions) as well as Validation Maintenance of computerized systems.
- ✓Participate in audits and inspections as a Subject Matter Expert.
- ✓Own, revise and maintain computer systems validation SOPs (Standard Operations Procedures).
- ✓Function as CSV SME in Inspections and Audits.
- ✓Mentor and train junior members of the department.
Show full description ↓Show less ↑
Computer Systems Validation Engineer
Location: Portsmouth, NH. Relocation assistance is available for eligible candidates and their families, if needed.
The Computer Systems Validation (CSV) Engineer will, as an individual contributor, identify and implement industry best practices through an extensive industry network and detailed knowledge of applicable regulations. During the scoping portion of these improvement projects the person in this role will work with other experienced members of the CSV team to identify roadblocks and additional efficiencies. Additional day to day tasks will include risk assessing systems, reviewing change requests and test scripts, drafting protocols and initiating and reviewing GMP documentation revisions.
What you will get
- •Competitive salary and comprehensive benefits package.
- •Opportunities for career development and advancement.
- •Supportive and collaborative team environment.
- •Access to cutting-edge technology and tools.
- •Commitment to employee well-being and safety.
- •Inclusive workplace culture.
- •Recognition and reward for your contributions.
Access to our full list of global benefits: https://www.lonza.com/careers/benefits
What we are looking for
- •Bachelor’s degree required, preferred in computer science, engineering, or other sciences.
- •Minimum of 5 years of experience working with automation and/or computerized system validations.
- •Minimum 2 years’ experience with Controls Automation, Process Control Systems, Distributed Systems, Manufacturing Execution Systems (MES) required, DeltaV preferred.
- •Prior experience leading or managing projects beneficial.
- •CAPAs and deviations experience desired.
- •Biotech/Pharma/Medical Device/Medical or biologics industry experience required.
- •Ability to work independently and meet deadlines successfully.
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.