5945 - GxP Instrument Systems Engineer / Senior Project Engineer

New Yesterday

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 and Enterprise Instrumentation Systems 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 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 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 Verista is an equal opportunity employer. National (US) Range $85,000—$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
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Location:
Boston, MA, United States
Salary:
$200,000 - $250,000
Job Type:
FullTime
Category:
Engineering

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