Senior Process Engineer / Lead Process Engineer
Description
This organization partners with some of the most recognized brands in the life sciences industry to address complex business needs. Its mission is to drive growth and innovation within the scientific community, supporting researchers, organizations, and companies in solving critical healthcare challenges. The team delivers innovative solutions and services that enable informed decision-making, backed by significant investment in people and capabilities.
Growth is fueled by exceptional professionals who thrive in collaborative environments and share a commitment to improving lives. These dedicated experts make an impact every day.
Culture & Values
- Empower and support colleagues
- Commit to client success at every turn
- Demonstrate courage to do the right thing
- Foster an inclusive environment where team members feel respected, engaged, and challenged
- Continuously acquire new skills and learn from experiences to enhance collective expertise
Lead Process Engineer Responsibilities
- Provide technical leadership for CIP/SIP processes, ensuring safe, efficient, and cGMP-compliant operations
- Lead or support process improvement and scale-up initiatives
- Conduct investigations, identify root causes, and implement corrective/preventive actions for manufacturing issues
- Develop and optimize process parameters to ensure 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, Production) for technology transfer and process validation
- Support equipment qualification and process validation for new or modified equipment/processes
- Analyze production data, generate reports, and recommend improvements to enhance performance and efficiency
- Ensure compliance with all safety and regulatory requirements in the manufacturing environment
Requirements
- Bachelor's degree or equivalent (STEM preferred; Biomedical or Chemical Engineering ideal)
- 7-10 years of relevant validation experience in pharma/biologics
- Minimum 5 years of cleaning validation experience, including:
- Hands-on experience with rinse and swab sampling and visual inspections
- Development of CIP and SIP cycles for process piping, transfer panels, and bioreactors
- Creation of load patterns for autoclaves and parts/glass washers
- Experience with Delta V automation for CIP/SIP
- Execution of Riboflavin studies
- Familiarity with Ellab ValSuite Pro and ValGenesis systems preferred
- Ability to work on-site full-time in Devens, MA
Compensation
National (US) Range: $85,000 - $150,000 USD
Actual salary depends on factors such as experience, training, location, and market conditions.
Benefits
- High growth potential in a fast-paced, people-focused organization
- Competitive pay plus performance-based incentives
- Company-paid life, short-term, and long-term disability insurance
- Medical, dental, and vision coverage
- FSA, DCARE, commuter benefits
- Supplemental life, hospital, critical illness, and legal insurance
- Health savings account
- 401(k) retirement plan with employer match
- Paid time off (with rollover option) and holidays
- Sick time as needed
- Tuition reimbursement
- Team social activities
- Employee recognition and referral programs
- Paid parental leave and bereavement
FAQs
Congratulations, we understand that taking the time to apply is a big step. When you apply, your details go directly to the consultant who is sourcing talent. Due to demand, we may not get back to all applicants that have applied. However, we always keep your CV and details on file so when we see similar roles or see skillsets that drive growth in organisations, we will always reach out to discuss opportunities.
Yes. Even if this role isn’t a perfect match, applying allows us to understand your expertise and ambitions, ensuring you're on our radar for the right opportunity when it arises.
We also work in several ways, firstly we advertise our roles available on our site, however, often due to confidentiality we may not post all. We also work with clients who are more focused on skills and understanding what is required to future-proof their business.
That's why we recommend registering your CV so you can be considered for roles that have yet to be created.
Yes, we help with CV and interview preparation. From customised support on how to optimise your CV to interview preparation and compensation negotiations, we advocate for you throughout your next career move.