5679 - CQV Engineer / Validation Engineer 2 New Devens, MA

Verista; Harvard (MA); On-site; USD 70,000 - 114,000; Full time

Job summary

Join an innovative firm dedicated to empowering growth in the life sciences industry. This role offers the chance to work alongside a talented team, solving pressing healthcare challenges through cutting-edge solutions. You'll engage in critical activities, ensuring compliance with quality standards while developing your skills in a supportive environment. With a focus on teamwork and continuous learning, this position promises both professional growth and the satisfaction of making a real impact in the scientific community. If you're ready to take on challenges and contribute to meaningful projects, this opportunity is perfect for you.

Benefits

Company-paid Life Insurance

Short-Term Disability Insurance

Long-Term Disability Insurance

Health Savings Account

Paid Time Off

Holidays

Tuition Reimbursement

Team Social Activities

Employee Recognition

Paid Parental Leave

Qualifications

• 2-4 years' experience in CQV activities specific to Process Equipment.
• Independent understanding of client's quality standards and regulatory standards.

Responsibilities

• Completing user interface testing and software verification.
• Managing and collaborating with clients’ quality representatives.

Skills

CQV activities

Trackwise/QMS software

Microsoft Office

GMP

Good Documentation Practice

Problem-solving skills

Critical thinking skills

Organizational skills

Time management skills

Interpersonal skills

Education

Bachelor’s Degree or equivalent

Tools

Microsoft WORD

Microsoft EXCEL

Microsoft PowerPoint

Job description

Description

Verista’s 500 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
• Adherence with project schedule for all assigned activities
• Maintaining clear, detailed records qualification and validation compliant to GDP
• Documenting impact and risk assessments as part of a team
• Completing user interface testing, software verification, and complete alarm testing on automated systems
• Developing, reviewing, and executing testing documentation
• Making recommendations for design or process modification based on test results when executing test scripts
• General understanding of capital equipment implementation and process knowledge
• Independent understanding and ability to draft and execute validation documents, URS, IQ, OQ, PQ
• Independentunderstanding of client’s quality standards, cGMP’s, and regulatory standards to support team in compliance of validation effort.
• Independent verification of testing against specifications.
• Managing and working collaboratively with clients’ quality representative to complete deviation investigation and resolution for problems and issues encountered during execution activities. Includes ability to complete root cause analysis.
• Supporting clients change management program – including authoring proposed changes, executing impact assessments/ regression analysis, and supporting clientdocumentation of change results and release.
• Direct experience installing, qualifying and decommissioning LN2 (Liquid Nitrogen) Tanks

Requirements:

• Must be willing to work onsite in Devens, MA
• Bachelor’s Degree or equivalent required
• 2-4 years' experience in leading CQV activities specific to Process Equipment
• Experience with Trackwise/QMS software
• 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
• GMP and Good Documentation Practice
• Intermediate skills with WORD (authoring/editing large technical documents with styles, tables, TOCs, track changes)
• Basic skills with EXCEL and PowerPoint
• Strong interpersonal skills and clear communication capabilities
• Experience with and tolerance for high levels of challenge and change
• Experience in GMP regulated environment
• Proven attention to detail and organization in project work
• Capable of working on assigned tasks without mentorship

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.

National (US) Range

$70,491 - $113,521 USD

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.
• Supplemental Life, Hospital, Critical Illness and Legal Insurance
• Health Savings Account
• 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

Verista collects and processes personal data in accordance with applicable data protection laws. If you are a California Job Applicant, see the privacy notice for further details.

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

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