Documentation Control Lead / Project Engineer - 5073 - Verista

Verista’s 600 experts team up with the world’s most recognizable brands in the life science industry to solve their business needs. The nature of our business is to empower growth and innovation within the scientific community and to help researchers, organizations, and companies solve some of the world’s most pressing healthcare challenges. Verista provides innovative solutions and services that empower informed decision-making and are the result of our significant investment in our people and our capabilities.

Our ability to grow is driven by world-class people who thrive in a team environment and share our mission to enable life sciences clients to improve lives. Our talented and dedicated professionals are committed to making an impact every day.

Company Culture Guidelines & Values:

• We empower and support our colleagues
• We commit to client success at every turn
• We have the courage to do the right thing
• We encourage an inclusive environment where our colleagues feel respected, engaged, and challenged.
• We constantly acquire new skills and learn from our experiences to enhance our collective expertise

Associate Project Engineer 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
• 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

• Must be willing to work onsite in New Brunswick, NJ
• 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.
• TOP review and compilation
• Proficiency using PC and Microsoft Office tools.
• Outgoing personality with strong ability to communicate effectively with peers in clear, concise terms.
• Ability to work as part of a team.
• Strong problem-solving and critical thinking skills.
• Excellent organizational and time management skills.
• Strong attention to detail 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

Why Choose Verista?

• 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

For more information about our company, please visit us at Verista.com

For US geography, the salary range for this position is shown below. The actual salary is dependent upon a variety of job-related factors such as professional background, training, work experience, location, business needs, market demand, and competitive market practice. Therefore, in some circumstances, the actual salary could fall outside of this expected range. This salary range is subject to change and may be modified in the future.

*Verista is an equal opportunity employer.