Associate Project Engineer - 5073

Verista - New Brunswick, NJ

Full-time - Mid Level

New Brunswick, NJ

501-1,000 employees

About the position

The Associate Project Engineer at Verista plays a crucial role in managing validation documentation and ensuring compliance with regulatory standards in the pharmaceutical industry. This position involves collaboration with various teams to support project milestones and assist in audits and inspections, contributing to the overall success of life sciences clients.

Responsibilities

• Manage validation documentation in automated systems, including document control and archiving.
• Perform quality reviews of IQ/OQ/PQ protocols, test scripts, and validation reports.
• Collaborate with the CQV and engineering teams to ensure documentation aligns with project milestones.
• Assist in audits and inspections by providing necessary documentation.
• Ensure all document control activities comply with FDA, cGMP, and internal quality standards.

Requirements

• Bachelor's degree in Life Sciences, Engineering, or related field.
• 8+ years of experience in document control and quality assurance in pharmaceutical settings.
• Expertise in validation documentation management and quality review processes.
• Strong understanding of regulatory requirements, including FDA and cGMP.
• Excellent attention to detail and organizational skills.
• Proficiency using PC and Microsoft Office tools.
• Strong problem-solving and critical thinking skills.
• Excellent organizational and time management skills.

Nice-to-haves

• Training with MS Project or other PM packages.
• GMP and Good Documentation Practice training (may be completed at onboarding).
• Intermediate skills with WORD (authoring/editing large technical documents with styles, tables, TOCs, track changes).
• Basic skills with EXCEL and PowerPoint.

Benefits

• High growth potential and fast-paced organization with a people-focused culture
• Competitive pay plus performance-based incentive programs
• Company-paid Life, Short-Term, and Long-Term Disability Insurance
• Medical, Dental & Vision insurances
• FSA, DCARE, Commuter Benefits
• Supplemental Life, Hospital, Critical Illness and Legal Insurance
• Health Savings Account
• 401(k) Retirement Plan (Employer Matching benefit)
• Paid Time Off (Rollover Option) and Holidays
• As Needed Sick Time
• Tuition Reimbursement
• Team Social Activities (We have fun!)
• Employee Recognition
• Employee Referral Program
• Paid Parental Leave and Bereavement