Quality Systems Engineer - CSV Specialist

Description

The company is a trusted partner to major brands, offering engineering, supply chain and manufacturing services. It has 60 years of experience and more than 100 sites worldwide, and it combines global reach with local know-how.

You will be the site subject matter expert for computer software validation, data integrity and GxP computerized systems at the Clinton/Devens site. You will oversee the validation lifecycle of regulated software, lead and support validation projects, run risk assessments for new systems and periodic reviews for existing ones, and keep the site inventory of GxP impacting systems current. You will work across departments and keep the site aligned with the global team.

Responsibilities

• Write, update and maintain the quality management system documents for the computer software validation process.
• Keep the GxP system inventory that lists the software used at the site.
• Lead the periodic review process, including user access reviews for site software.
• Work with IT when hardware or software upgrades are required.
• Advise and support users on validation activities.
• Act as the site CSV and data integrity expert during audits, investigations, CAPAs and compliance work.
• Serve as secondary owner of the QMS and LMS software, supporting site administration, maintenance and compliance with regulatory and customer requirements where applicable.
• Write, review and approve user requirement specifications, validation plans, risk assessments, test protocols and reports, and validation summary reports.
• Make sure change notices are used correctly for document submissions and changes.
• Take part in problem solving and process improvement work.
• Support programs tied to the healthcare ethics code, company values and sustainability.
• Take on other duties as the company and the department need over time.

Requirements

• Bachelor's degree in engineering, science or a related field (preferred).
• 1-2 years of software validation experience. Experience in medical device or pharmaceutical settings is preferred, but experience from any industry is accepted.
• Knowledge of ISO 13485 and FDA 21 CFR Part 820 (preferred).
• Strong attention to detail, follow-through and organization.
• Self-motivated, able to work on your own with little supervision or guidance.
• Working knowledge of CSV practices in a regulated medical device manufacturing setting, including 21 CFR Part 820, 21 CFR Part 11, ISO 13485, Good Documentation Practices (GDP) and Good Manufacturing Practices (GMP) (preferred).

Conditions

This role is not eligible for immigration or visa sponsorship. You must be legally authorized to work in the United States now and in the future without sponsorship from the company. Applicants who need sponsorship will not be considered.

The role is based at the Clinton/Devens site.

Benefits

• Competitive base salary of $64,700 to $103,500. The actual offer depends on qualifications, experience, education, location, external market data and internal equity.
• Medical, dental, prescription drug and vision insurance, with HRA and HSA options.
• Life, AD&D and disability insurance.
• 401(k) with company match.
• Employee stock purchase plan.
• Paid time off and paid parental leave.
• Company-paid holidays, which may change yearly.
• Tuition reimbursement.
• Commuter benefits.
• Employee assistance program.
• Pet insurance.
• Adoption assistance.
• Annual merit increases.
• Community volunteer opportunities.