Principal Automation Engineer - 5086

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

Principal Automation Engineer Responsibilities:

• Perform GMP / GLP Activities
• SCADA, BAS, Maximo, and other automation engineering Systems Administration
• Monitoring of system performance and operability
• Develop appropriate Change Controls to enhance systems and operation
• System Modifications per Change Control
• Develop appropriate Validation Protocols, Reports, and Life-Cycle documents
• Execution of Validation Protocols
• Automation Systems Management
• Develop appropriate automation for bioprocess equipment including single-use bioreactors, chromatography controllers, ultrafiltration skids, and benchtop instruments
• Author appropriate Change Controls and Test Scripts and serve as Manufacturing’s
• Subject Matter Expert for applicable changes
• Recommend and integrate new bioprocess equipment and Process Analytical
• Technologies (PAT)
• Ability to prioritize and juggle multiple concurrent projects and day-to-day requests.
• Liaison with Business, Managed Services, and IT to coordinate the IT Change Request processes
• Maintain current knowledge base of solutions and work with Managed Services sustainment teams to facilitate technical break / fixes

Requirements

• Candidate must be local to Hopewell, NJ.
• Knowledge of domestic / international regulatory guidelines / compendia, (FDA, ICH, USP and EMEA guidelines) for validation of equipment and systems.
• Knowledge of applicable cGMP/GLP requirements, procedures, methods, and protocols for performance of assigned duties & responsibilities.
• Training:
• cGMP training
• Applicable Corporate and Departmental Directives, Policies, and Procedures
• Good Manufacturing Practices and Good Documentation Practices
• QA Quality General
• Hopewell Biologics Manufacturing General/All
• HBM Automation Control and Data Acquisition
• Engineering EHS Training
• Lab/Biological Safety EHS Training
• Hopewell Biologics Manufacturing Gowning
• Bachelor of Science in Electrical Engineering, Computer Science, IT, Engineering, or related field of study with at least six years of related experience that provides direct scientific knowledge of system automation validation principles and biologics production equipment/systems.
• Direct knowledge of the biologics process equipment, SCADA/control systems, and validation practices
• Expertise in scientific / technical subject areas – Equipment Qualification, Computer System Validation, Cleaning Validation, SCADA system architecture, Biotech Process Equipment/Systems Proficient in use of electronic systems- Microsoft Office, various specialized software including process documentation Veeva Vault, Material Management (SAP), Computerized Maintenance Management System (Maximo), Building Automation System (BAS).
• Expertise in Rockwell Automation (Allen Bradley) programming software and Wonderware SCADA Systems.
• Familiarity with OSI Pi a plus.
• Analytical thinker with excellent problem-solving skills and the ability to adapt to changing priorities and deadlines
• Excellent planning, organization and time management skills including the ability to support and prioritize multiple projects

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.

$107,800 - $172,000

*Verista is an equal opportunity employer.