6041 - Senior Process Engineer / Lead Process Engineer

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

Lead Process Engineer Responsibilities:

• Lead/Provide technical support for CIP/SIP, ensuring processes operate safely, efficiently, and in compliance with cGMP regulations
• Lead or support process improvement and scale-up projects
• Conduct process investigations, identify root causes, and implement corrective/preventive actions to resolve manufacturing issues
• Develop and optimize process parameters to achieve consistent product quality and yield
• Prepare and review process documentation including batch records, SOPs, validation protocols/reports, and change control documents
• Collaborate with cross-functional teams (R&D, Quality, Validation, Maintenance, and Production) to ensure successful technology transfer and process validation
• Support equipment qualification and process validation activities for new or modified equipment/processes
• Analyze production data, generate reports, and recommend process or equipment improvements to enhance performance and efficiency
• Ensure compliance with all safety and regulatory requirements within the manufacturing environment

Requirements:

• Bachelor’s Degree or equivalent required (STEM degree, Biomedical Engineering, Chemical Engineering preferred)
• 7-10 years of relevant Validation Experience within pharma / biologics
• Minimum 5 years of Cleaning Validation experience to include:
  1. Hands-on experience taking rinse and swab samples and performing visual inspection
  2. Experience developing CIP and SIP cycles for process piping, transfer panels, and bioreactors
  3. Experience developing load patterns for autoclaves and parts / glass washers
  4. Experience with Delta V automation for CIP / SIP
  5. Hands on experience executing Riboflavin studies
• Experience using Ellab ValSuite Pro and ValGenesis systems preferred

This role requires the ability to be on-site, full-time in Devens, MA.

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