6274 - Senior Process Engineer / Lead Process Engineer at Verista, Inc.

Devens, Massachusetts, United States -

Full Time

Start Date

Immediate

Expiry Date

21 Jun, 26

Salary

144000.0

Posted On

23 Mar, 26

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

CIP, SIP, cGMP Regulations, Process Improvement, Scale-up Projects, Process Investigations, Root Cause Analysis, Process Optimization, Batch Records, SOPs, Validation Protocols, Change Control, Technology Transfer, Equipment Qualification, Data Analysis, Delta V Automation

Industry

Pharmaceutical Manufacturing

Description

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. 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 $85,000—$144,000 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

Responsibilities

The Lead Process Engineer will lead or provide technical support for CIP/SIP processes, ensuring safety, efficiency, and cGMP compliance, while also leading or supporting process improvement and scale-up projects. Responsibilities include conducting process investigations, developing optimal process parameters, and preparing/reviewing essential process documentation like batch records and validation reports.