Automation Engineer / Senior Automation Engineer 2 - 5246

Posted 12 Days Ago
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Warren, NJ
85K-130K Annually
Mid level
Pharmaceutical
The Role
The Automation Engineer will manage the lifecycle of project-related documents for automation and commissioning, ensuring compliance with regulatory standards. Responsibilities include developing commissioning schedules, managing vendor interactions, conducting Factory and Site Acceptance Testing, and ensuring documentation aligns with Good Documentation Practices for audit readiness.
Summary Generated by Built In

Description

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

Automation Engineer Responsibilities:

We are looking for an experienced Automation Engineer with DeltaV expertise to oversee commissioning and qualification efforts, ensuring automation systems meet project and regulatory compliance standards required for production readiness.

Key Responsibilities

  • Document Control - The Automation Engineer will manage the lifecycle of all project-related documents for automation and commissioning activities. This includes:
    1. Setting up and maintaining a structured storage system in the designated document repository, ensuring proper organization, accessibility, and security.
    2. Uploading, tracking, and revising documents in real-time to align with project progress.
    3. Routing documents for review and approval to ensure compliance with established procedures.
    4. Ensuring all documentation complies with Good Documentation Practices (GDP) and is finalized for audit readiness.
  • Commissioning Phase Deliverables - During the commissioning phase, the Automation Engineer will generate and oversee the following key deliverables:
    1. System-Based Commissioning Schedules: Develop schedules that outline the order and timeline for commissioning activities, with clear milestones
    2. System Boundaries Documentation: Define and document system boundaries to clarify the scope of commissioning for each subsystem
    3. Vendor Management Documentation: Prepare and track documentation for vendor interactions, including startup protocols, handover documents, and equipment certifications
    4. Factory Acceptance Testing (FAT) Reports: Complete and document all FAT processes, verifying that the equipment functions per specifications before delivery to the site
    5. Receipt Verification: Conduct inspections and verification checks upon receiving equipment to ensure it matches project specifications and is ready for installation
    6. Site Acceptance Testing (SAT): Perform on-site tests to validate that the equipment operates correctly within the installed environment, producing a detailed SAT report
  • Execution Phase Deliverables - As part of the qualification and validation execution, the Automation Engineer will develop and manage the following deliverables:
    1. Installation Qualification (IQ) Protocols and Reports: Document the installation process, verifying that all components are installed according to design specifications and safety standards
    2. Operational Qualification (OQ) Protocols and Reports: Ensure equipment performs as expected in its operational environment by executing OQ protocols and documenting results
    3. Performance Qualification (PQ) Protocols and Reports: Validate that the system meets all performance criteria and supports manufacturing needs, with comprehensive PQ documentation
    4. Change Management Documentation: Track and manage any changes to the systems or processes during execution, including engineering change forms and logs
    5. Traceability Assessment: Confirm that all equipment and processes align with project specifications and regulatory standards, providing a clear record of system traceability
    6. Environmental, Health, and Safety Documentation: Ensure all automation activities comply with site and regulatory safety requirements, documenting any risks, mitigations, and safety tests
  • Additional Responsibilities:
    1. Regular Project Reporting: Provide consistent updates on commissioning and execution progress, budget, and schedule adherence
    2. Cross-Functional Collaboration: Work with C&Q, quality, and engineering teams to coordinate all automation deliverables and activities
    3. Vendor Management: Liaise with vendors for equipment setup, testing, and troubleshooting, ensuring deliverables meet project standards
Requirements
  • Bachelor’s degree in Electrical Engineering, Computer Science, or related field
  • Minimum of 5 years of experience in automation engineering, specifically with DeltaV systems, within a GMP-regulated environment
  • Proficiency in DeltaV systems and experience with electronic documentation systems
  • Strong communication, documentation, and problem-solving skills
  • Ability to work collaboratively in a dynamic, team-oriented environment
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 

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.

$85,000-129,826

*Verista is an equal opportunity employer.

Top Skills

Deltav
The Company
HQ: Fishers, IN
402 Employees
On-site Workplace
Year Founded: 2020

What We Do

Verista is a leading business and technology consultancy firm that provides systems, compliance, validation and quality solutions to life science companies - enabling them to improve health and improve lives. We help clients solve their most critical and complex challenges across the GxP lifecycle, from preclinical and clinical to commercialization, manufacturing and distribution – bringing together decades of knowledge, the most advanced engagement platforms and transformative technologies. This allows clients to benefit from the ease, efficiency and trust that results from working with one partner who excels across specialties. Verista’s clients trust the company’s 650+ experts to deliver consistent, safe, and high-quality results across the product development lifecycle. Verista is based in Fishers, Indiana, Wayne, Pennsylvania, Westford, Massachusetts, and San Mateo, California. For more information, visit www.verista.com

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