Instrument Manager - New Brunswick, NJ
Instrument Manager - New Brunswick, NJ
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$ 96930 - 117500
1 Vacancy
Job Description
ATTENTION MILITARY AFFILIATED JOB SEEKERS- Our organization works with partner companies to source qualified talent for their open roles. The following position is available toVeterans Transitioning Military National Guard and Reserve Members Military Spouses Wounded Warriors and their Caregivers. If you have the required skill set education requirements and experience please click the submit button and follow the next steps. Unless specifically stated otherwise this role is On-Site at the location detailed in the job post.
Challenging. Meaningful. Life-changing. Those arent words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here uniquely interesting work happens every day in every department. From optimizing a production line to the latest breakthroughs in cell therapy this is work that transforms the lives of patients and the careers of those who do it. Youll get the chance to grow and thrive through opportunities uncommon in scale and scope alongside high-achieving teams. Take your career farther than you thought possible.
Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits services and programs that provide our employees with the resources to pursue their goals both at work and in their personal lives.
Our Analytical Strategy and Operations team creates transformative medicines of tomorrow based on the cutting-edge science of today. Working within Global Product Development and Supply this team uses state-of-the art technologies to develop enable and execute analytical and CMC strategies that ensure safety quality and efficacy of life-saving medicines administered to patients in clinical studies. Our team is involved at the earliest stages of Pharmaceutical and Biopharmaceutical product development through the successful commercial launch. As a member of our team you will get the chance to play a pivotal role to positively impact patients lives while developing professionally to achieve your own career goals.
Role & Responsibilities:
Manage the full lifecycle of laboratory instruments including qualification data integrity maintenance repairs and decommissioning activities within assigned functional areas.
Oversee and coordinate instrument qualifications including vendor protocol pre-approval and collaborate with instrument owners vendors and IT teams to configure systems and complete data integrity risk assessments within required timelines.
Independently engage with instrument vendors to understand data flow software features data file generation and 21 CFR Part 11 compliance capabilities of application software.
Prepare review and approve data integrity risk assessments configuration specifications and qualification summary reports to ensure compliance for instrument release.
Facilitate and/or complete periodic calibration performance verification preventive maintenance and change control activities; manage instrument decommissioning as needed.
Review and approve vendor-executed calibration maintenance repair and performance verification tasks to ensure compliance with quality standards.
Manage schedules to ensure timely execution of qualification calibration performance verification testing and maintenance operations.
Partner with the quality assurance (QA) team to ensure the accuracy and completeness of documentation while addressing and resolving compliance issues under GMP regulatory standards.
Administer user account management activities including handling password resets and account configuration requests.
Verify and execute data backup and restoration tasks according to defined processes and timelines.
Ensure timely resolution of quality events to maintain compliance with relevant standards and procedures.
Participate in the development update or revision of Standard Operating Procedures (SOPs) to promote clarity consistency and regulatory alignment.
Support audit readiness efforts including providing information related to instrument qualification and maintenance programs during inspections or inquiries.
Additional Qualifications/Responsibilities
Experience &Qualifications:
Bachelor of Science degree in chemistry biology computer science or a related discipline with 57 years of relevant qualification experience. Or Masters degree with 2-4 years of relevant experience or PhD with 0-2 years of relevant experience
Demonstrated knowledge of compliance requirements under cGMP and FDA regulations including Good Documentation Practices (GDP) and laboratory GMP principles as outlined in 21 CFR Parts 210 and 211.
Excellent attention to detail organizational skills and ability to create accurate clear technical documentation.
Strong communication skills and technical writing expertise.
Proven ability to work independently and collaboratively with a results-oriented mindset and the ability to drive projects to timely completion.
Customer-focused attitude and commitment to meeting deadlines while delivering high-quality outcomes.
Strong interpersonal and teamwork skills with the ability to effectively interface and communicate technical information to colleagues and supervisors.
Self-motivated resourceful and adaptable with a proactive approach to problem-solving and task ownership.
Proficient in instrument/equipment qualification maintenance and change control processes.
Strong experience and comprehension of 21 CFR Part 11 compliance pertaining to computer systems including hardware application software and operating systems.
Solid grasp of Data Integrity principles in a GxP environment.
Experience in calibration maintenance repair and performance verification tasks for instrument lifecycle.
Skilled in document creation using pre-existing templates and/or standard operating procedure.
In-depth understanding of data file types generated by laboratory instruments and database structures.
The starting compensation for this job is a range from $96930 - $117500 plus incentive cash and stock opportunities (based on eligibility).
The starting pay rate takes into account characteristics of the job such as required skills and where the job is performed. Final individual compensation will be decided based on demonstrated experience.
Required Experience:
Manager
Employment Type
Full Time
