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5945 - GxP Instrument Systems Engineer / Senior Project Engineer
Boston, United States
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
The qualified GxP Instrument Systems Engineer / Senior Project Engineer will be responsible for the design, deployment and management of automation and digital enterprise instrumentation systems that support Quality Control laboratories and system integration with connected Digital platforms.
Job Responsibilities:
- Collaborate with Business Analysts and Software/Automation Engineers in the complete product lifecycle management of Digital Quality Automation Systems (Hamilton Venus, Waters Andrew+ with OneLab, etc.) and Enterprise Instrumentation Systems (Chromeleon Chromatography Data System, Scientific Data Management System (LogiLab), CFR Gateway (LogiLab), SoftMax Pro, MODA, etc.) including optimizations, support, maintenance updates and version upgrades
- Translate system/equipment/data integration requirements from various teams into deployable Digital Laboratory System solutions
- Manage change control for regulatory Digital documentation (SOPs, work instructions, etc.) required to demonstrate appropriate compliance
- Partner with stakeholders to validate and integrate key systems into the connected instrument pipeline, future robotics/automation capabilities and AI initiatives
- Identify opportunities to optimize current processes and implement upgraded solutions
- Ensure GMP compliance in the design, delivery and maintenance of all systems
- Maintain inspection readiness throughout the duration of the project
- Participate in internal and external audits as required
Requirements:
- Bachelor's degree or equivalent in science, engineering or computer science discipline
- 5 to 7+ years' experience designing, implementing, and managing life sciences enterprise systems (CDS, SDMS, LIMS, ELN, LES) in a biopharmaceutical GMP environment
- Direct experience with automation solutions such as Hamilton Venus
- Experience working with advanced automated laboratory analytical systems such as Waters Andrew+, Oxford Nanopore, and Hamilton Venus liquid handlers
- Experience with GAMP and GxP compliance regulation
- Experience with data integrity regulations, instrument integration and laboratory digital workflow optimization
- Experience with Digital systems hosted in the cloud and an understanding of connectivity between on-prem systems and SAAS/Cloud
- Strong understanding of core laboratory systems, related processes, and quality management workflows
- Ability to work independently and in a team setting, with the ability to effectively communicate cross-functionally
- Ability to support multiple concurrent projects in a fast-paced environment
- Strong interpersonal and relationship-building skills
- Ability to be on-site 3-4 days/week between Marlborough, MA and Norwood, MA locations
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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