Computer Systems Validation Engineer

Lonza; Portsmouth (NH); On-site; Confidential; Full time

Benefits offered by this job

Competitive salary

Comprehensive benefits package

Opportunities for career development

Supportive team environment

Access to cutting-edge technology

Inclusive workplace culture

Recognition for contributions

Job summary

Lonza is seeking a Computer Systems Validation Engineer located in Portsmouth, NH. This pivotal role involves implementing industry best practices and oversight of quality systems management. Ideal candidates will have at least 5 years of relevant experience and a degree in a technical discipline.

Responsibilities include leading efforts in CSV, participating in audits, and mentoring junior staff. The position offers competitive salary and comprehensive benefits within a supportive work environment.

Qualifications

• Minimum of 5 years of experience with automation and computerized system validations.
• Minimum of 2 years’ experience with Controls Automation, Distributed Systems, and MES.
• Prior experience leading or managing projects is beneficial.

Responsibilities

• Lead efforts between internal customers and CSV for prioritizing activities.
• Accountable for maintaining knowledge of policies, regulations, and industry standards.
• Perform Quality Systems Management processes and Validation Maintenance.
• Participate in audits and inspections as a Subject Matter Expert.
• Own, revise, and maintain computer systems validation SOPs.
• Mentor and train junior department members.

Skills

Automation and computerized system validations

Controls Automation

Process Control Systems

Manufacturing Execution Systems (MES)

Project management

Education

Bachelor’s degree in computer science, engineering, or related sciences

Job description

Computer Systems Validation Engineer

United States, Portsmouth (New Hampshire)

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.

Responsibilities

• 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 Preventive 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 Operating Procedures).
• Function as CSV SME in Inspections and Audits.
• Mentor and train junior members of the department.

Qualifications

• 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.

Equal employment opportunities are available 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.