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5694 - Process Engineer / Senior Process Engineer 2

Various Travel - Some Overseas

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

Process Engineer 2 Responsibilities:

This role is responsible for providing technical support regarding the execution of 4 Process Performance Qualifications (PPQ) by visiting the tech transfer receiving sites and evaluating the current state of operational readiness through the execution of pFMEA for each site.

General Process Engineering 2 Responsibilities:

  • Develop and execute current state operational readiness assessment pFMEAs 
  • Report findings with recommendations and escalate critical risks/gaps identified timely
  • Support resolution of identified gaps, identifying root causes and defining corrective/preventive actions with equipment, processes and automated systems
  • Possess demonstrated technical skills and knowledge with biopharmaceutical operations specifically Monoclonal Antibody (Manufacturing)
  • Possess understanding of engineering drawings, SOPs, vendor documentation, and other technical documentation
  • Efficiently and effectively manage assigned projects and initiatives
  • As required by group, assist Senior and Principle Engineers on more complex projects/initiatives

Requirements:

  • Bachelor's degree in engineering or equivalent field
  • 6 to 10 years or role specific experience required
  • Advanced experience executing pFMEAs, PPQs and assessing and reporting on the current state of Operational Readiness.
  • Ability to assess and report on process validation activities involving cross-functional teams including Manufacturing, Process Sciences, Process Development, Quality Control, Quality Assurance, Regulatory Affairs, and others
  • Comfortable walking through all areas of the production module (CNC space, ISO classified rooms, grey space).Knowledge of the product flow through the various production areas.
  • Strong Understanding of process fundamentals and qualification/validation requirements for the following:
    • Small molecule chemical synthesis
    • Monoclonal antibody or protein biomanufacturing
    • Cell therapy and regenerative medicine
    • Sterile drug product fill/finish
    • Analytical QC laboratories
    • Computer System
    • Packaging
  • Ability to interact directly and communicate concisely with senior management
  • Advanced Microsoft Project capabilities.
  • Familiar with regulatory audit process and capable of assessing provided supporting documents
  • Proficient in computer skills and MS Office applications

This role will be traveling to various sites, with some overseas travel required.

 

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 - $136,225 USD

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

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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