Csv Validation Engineer Jobs in Virginia (NOW HIRING)

BeOne continues to grow at a rapid pace with challenging and exciting opportunities for experienced professionals. When considering candidates, we look for scientific and business professionals who are highly motivated, collaborative, and most importantly, share our passionate interest in fighting cancer.

General Description:

BeOne Medicines is seeking a highly motivated and organized Site Automation Engineer to join our team at the Hopewell, NJ site. The successful candidate will be responsible for maintaining a stable, qualified, and highly available computing infrastructure and implementation of validated computer systems for the shop floor and process automation systems, in close collaboration with the Global Technology Solutions (GTS) team. The individual ensures reliable operation and implementation of all automation systems for a 24x7 commercial manufacturing facility. This role works independently, with minimal supervision and direction and will provide technical direction, Project Management support, Commissioning and SME expertise in the areas of Facility, Utility and Metrology, instrumentation /control services. Projects may often require independent decision making and exercising judgment. This role will be based in Hopewell NJ and report to the Senior Engineer II, Site Automation.

Responsibilities:

• Primarily support the Building Automation System.

• Support the site Process Equipment.

• Support projects in the design, development, and qualification of automated processes, equipment, and systems; including managing the work of internal engineers and outside vendors

• Support the design, development, and qualification of automated processes, equipment, and systems and identify opportunities to improve existing processes, equipment, systems, and infrastructure

• Develop and review technical documentation

• Support of various Control System hardware and software

• Participate and lead in controls fault analysis and remediation

• Support the configuration, administration and maintenance activities of the site manufacturing and automation systems, including process control systems, building automation systems, manufacturing execution systems, and data historian

• Directly support operations with troubleshooting and issue resolution with respect to computer and automation systems

• Work on small cross functional teams in support of small projects or initiatives

• Requires working in an industrial manufacturing environment including gowning

• Support operations and ensure compliance with regulatory, corporate and site requirements

• Collaborate and work closely with Automation teams at other sites in China

• The ability to operate self-sufficiently and to motivate oneself is crucial for the success of this position. In addition, the ability for this person to develop and maintain transparent communication between departments is essential

Required Skills/Experience:

• Bachelor's degree in engineering and/or related discipline and 5+ years of biopharmaceutical manufacturing, engineering, and/or project management and at least 3 years of project management experience in biologics or GMP required.

• Master's degree and 4+ years of experience preferred

• Minimum of 5+ years of GMP pharmaceutical operations support.

• Strong experience with software lifecycle methodologies, 21CFR Part 11 compliance, and GxP computer systems validation (CSV)

• Strong experience with the following platforms is required: Rockwell PlantPAX DCS, Allen Bradley PLC, Rockwell FTView, FTAssetCentre, MS-SQL.

• Experience with Siemens PLCs, WinCC, ABT Site, and OSI PI Historian is recommended.

• Experience with Ignition SCADA is a plus.

• Experience with instrumentation and control panel hardware as required by the job

• Experience with computer systems validation practices (GAMP)

• Excellent communication and interpersonal skills, with the ability to collaborate across functional teams.

• Proven ability to manage multiple complex priorities simultaneously under tight timelines.

• Analytical problem-solving skills and proactive decision-making.

• Ability to summarize and present project information clearly to management.

Preferred Skills/Experience

• OE and/or LEAN Methodologies

Physical Requirements:

• Ability to work in an office environment, construction site, and laboratory or manufacturing areas.

• May require up to 5% travel, including visits to partners or manufacturing sites.

• Must be able to sit, stand, and use standard office equipment for extended periods.

Global Competencies

When we exhibit our values of Patients First, Driving Excellence, Bold Ingenuity and Collaborative Spirit, through our twelve global competencies below, we help get more affordable medicines to more patients around the world.

• Fosters Teamwork
• Provides and Solicits Honest and Actionable Feedback
• Self-Awareness
• Acts Inclusively
• Demonstrates Initiative
• Entrepreneurial Mindset
• Continuous Learning
• Embraces Change
• Results-Oriented
• Analytical Thinking/Data Analysis
• Financial Excellence
• Communicates with Clarity

BeOne is committed to fair and equitable compensation practices. Actual compensation packages are determined by several factors that are unique to each candidate, including but not limited to job-related skills, depth of experience, certifications, relevant education or training, and specific work location. Packages may vary by location due to differences in the cost of labor. The recruiter can share more about the specific salary range for a preferred location during the hiring process. Please note that the listed range reflects the base salary or hourly range only. Non-Commercial roles are eligible to participate in the annual bonus plan, and Commercial roles are eligible to participate in an incentive compensation plan. All Company employees have the opportunity to own shares of BeOne Medicines Ltd. stock because all employees are eligible for discretionary equity awards and to voluntarily participate in the Employee Stock Purchase Plan. The Company has a comprehensive benefits package that includes Medical, Dental, Vision, 401(k), FSA/HSA, Life Insurance, Paid Time Off, and Wellness.

We are proud to be an equal opportunity employer. BeOne does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, disability, national origin, veteran status or any other basis covered by appropriate law. All employment is decided on the basis of qualifications, merit, and business need. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans' Readjustment Assistance Act of 1974, Title I of the Americans with Disabilities Act of 1990, and any other applicable federal, state or local laws, applicants who require reasonable accommodation in the job application process may contact accommodationsus@beonemed.com.