LabWare LIMS Project Manager

LabAnswer; Boston (MA); Sur place; USD 90 000 - 120 000; Plein temps

Avantages offerts par ce poste

Health Insurance

401(k) Retirement Savings with employer match

Company Paid Short and Long Term Disability Insurance

Training programs for career advancement

Competitive compensation with bonus opportunities

Résumé du poste

LabAnswer is seeking a leader to provide IT Project oversight for a laboratory systems validation project, particularly focusing on LabWare LIMS. The ideal candidate should have at least 5 years of Project Management experience in a Pharmaceutical/R&D environment and will play a critical role in managing and implementing laboratory systems.

The position involves collaboration across teams, ensuring compliance with FDA regulations, and contributing to various projects within the organization. Comprehensive benefits and growth opportunities are offered to full-time employees.

Qualifications

• 5+ years of experience in project management, specifically in lab systems validation.
• Strong understanding of computer and application architecture.
• Ability to work within a regulatory environment.

Responsabilités

• Oversee IT Project Management for LabWare LIMS implementation.
• Coordinate new functionality or upgrades related to LIMS.
• Ensure compliance with regulatory requirements during project execution.

Connaissances

Project Management

LabWare LIMS

GMP

Analytical Skills

Formation

Bachelor Degree in a related discipline

Description du poste

At LabAnswer, we’re looking for a leader to provide IT Project oversight for a laboratory systems validation project. This person must have at least 5 years of Project Management experience with managing LabWare LIMS projects.

Job Requirements

• Serve as a IT Project Management and UAT resource for a LabWare LIMS implementation.
• Set priorities for problem resolution.
• Develop relationships with vendors and 3rd‑party consultants.
• Communicate pertinent system information to site/project leadership as needed.
• Identify, document and communicate new site business requirements.
• Coordinate implementation of new functionality or upgrades.
• Maintain a communication process with the other sites to maximize resource usage.
• Maintain system‑related SOPs and create UAT scripts.
• Assist in working with business to identify data needs in new LIMS system.
• Provide strategic direction to the IT, Scientific, and Management teams based on combination of industry and technical knowledge.
• Assist in creating and maintaining SDLC documentation.
• Assist in working with Development team to implement and test accuracy and completeness of data migration.
• Contribute in all areas of system implementation including but not limited to vendor interaction, system compatibility, change control, qualification, deployment, and training.
• Work with project teams to ensure compliance with regulatory requirements such as FDA, CAP, CLIA, as well as internal policies and processes.
• Identify the optimum combination of applications that meet the requirements of disparate laboratory and business functions.

Qualifications

A qualified candidate will possess:

• Knowledge of LabWare LIMS.
• Experience with managing a laboratory systems validation project in a Pharmaceutical/R&D environment.
• Excellent verbal and written communication skills.
• Expert understanding of GMP.
• Demonstrated experience implementing enterprise data capture/management technologies.
• Ability to contribute to multiple projects for different business stakeholders.
• Experience implementing technology under a defined corporate and compliant methodology.
• Expert understanding of computer and application architecture, technology, and validation.
• Strong analytical and problem‑solving skills.

Education: Bachelor Degree in a related discipline and five+ years of project management, systems implementation and analysis experience. Emphasis should be on laboratory tools for R&D or Quality groups of an FDA regulated environment.

Additional Information

We offer comprehensive benefits to regular full‑time employees including but not limited to:

• Unlimited ceiling for professional growth opportunities within LabAnswer.
• You will also have opportunities to take advantage of training programs to advance your career; our extensive online library includes an assortment of technical and professional training tools and resources.
• Opportunities to work across a variety of industries (Pharmaceutical, Medical Device, Consumer Products, Energy, Environmental, Forensics, Genomics, Government, etc.).
• Opportunities to work across a variety of laboratory environments (analytical testing, biotech, clinical trials, forensics, medical device, pharmaceutical, public health and research hospitals).
• Health Insurance.
• 401(k) Retirement Savings with employer match.
• Company Paid Short and Long Term Disability Insurance.
• Wellness Plans and Rewards.
• Strong company values of teamwork, culture and values, personal and professional development, work‑life balance, and recognition.
• Competitive compensation with opportunities to participate in employee bonus plan and travel bonus plan.