Overview 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.
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
On-site availability 3-4 days/week between Marlborough, MA and Norwood, MA locations
Salary and Benefits 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.
(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 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
Tuitions 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
#J-18808-Ljbffr