No Open Roles At This Time

No Open Roles At This Time

No Open Roles At This Time

No Open Roles At This Time

No Open Roles At This Time

Facilities Specialist

Job Summary

Oversee work orders, manage manufacturing equipment maintenance and recertification, handle equipment and room cleaning, troubleshoot equipment, conduct GMP inspections, and maintain GMP records. Plus, you’ll be a key player in revising SOPs, boosting equipment reliability, and planning/scheduling facility shutdowns.

Summary:

• Compliance: Making sure everything meets strict GMP, safety, maintenance, cleaning standards. Think guardian of our compliant environment!
• Planning and Organizing: Organizing renovations, working with stakeholders to coordinate and schedule equipment, building shutdowns for maintenance, calibration, recertification works, and capital project executions – all to minimize disruption and keep our space optimized.
• Leadership: Supervise facilities staff and subcontractors to ensure efficient coordination and execution of work
• Administrative: Handling records, POs, SOP revisions, GMP logbooks, insurance, and keeping everything documented.
• Reliability: Proactively maintaining the GMP building and its infrastructure to ensure smooth and reliable operation.
• Ensures adherence to relevant regulatory requirements and Company Standard Operating Procedures (SOPs) as appropriate.

Job Responsibilities

• Creates Scope of Work, Request for Proposals, and Purchase Orders for infrastructure changes, capital projects, lab renovations, mechanical equipment repairs, replacements, and safety equipment maintenance.
• Negotiates with contractors on pricing proposals in conjunction with facilities engineering.
• Serves as a liaison for Capital Projects, Environmental Health & Safety, Facilities, and Site Protection, managing renovation and reconfiguration projects for critical utilities, GMP processes and laboratory equipment, offices, and common areas.
• Initiates project requests, approves designs, and guides affiliated offices, vendors, and contractors, while coordinating project management with capital projects and facilities services.
• Assigns and monitors cleaning and maintenance responsibilities to contractors and conducts routine GMP and safety inspections (daily facility walk-throughs or as needed), monitoring interior and exterior areas of the building for cleanliness and general upkeep.
• Handles infrastructure issues affecting buildings (e.g., HVAC, carpentry, electrical, plumbing, DI water, equipment and room certifications, and others).
• Prepares labs to custom specifications, ensures that equipment is installed upon arrival, and prepares and implements project budgets and timeframes.
• Supports maintenance and installation work, supervises vendors, and ensures they perform work assignments safely and per contracted terms, including routine maintenance on mechanical, airflow, fluid pumping equipment, electrical, refrigeration, and plumbing repairs.

Required Knowledge, Skills, and Abilities

• GMPs and Safety knowledge required, especially in manufacturing environments.
• Advanced mechanical and plumbing skills related to exhaust fans, boilers, chillers, air compressors, and other utility systems.
• Collaborate effectively with stakeholders and cross-functional teams.
• Knowledge of HVAC, EMS, BMS, and other related building systems.
• Excellent project and time management, as well as multitasking skills.
• Basic understanding of accounting and finance principles.
• Strong communication, leadership, problem-solving, and troubleshooting skills.
• Minimum 3 years of work experience in pharma, biotechnology, or chemistry lab facilities, with certifications such as Boiler Operator or Refrigeration Engineering preferred.
• Ability to work occasional weekends, holidays or overtime as needed to fulfil the business needs.

Preferred qualifications

• Professional leadership experience and contract handling expertise.
• Experience planning and maintaining facility budgets.
• Excellent verbal and written communication skills.
• Strong attention to detail and excellent organizational skills.
• Ability to exercise independent judgment, prioritize diverse workloads, and creatively solve problems.
• Ability to manage multiple priorities in a fast-paced, changing environment, take initiative, self-motivate, and work effectively in a team-based environment.

Job Specifications

Education and Experience Requirements

Degree in Mechanical or Chemical Engineering with 3+ years’ experience in facilities management, preferably in pharma, biotechnology, or chemistry lab facilities.

Physical Demands

Ability to lift heavy objects (≤50 lb.) and perform other labor-intensive tasks as required.
Sitting, standing, walking

Working Conditions

Office environment/laboratory
Manufacturing environment
Working hours: 3 pm to 11 pm EST

Certifications & Licenses Required

N/A

Confirm Job Qualifier To Apply

NJ Bio, Inc. is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to their race, color, sex, religion, age, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability or any other characteristic protected by applicable federal, state, or local laws.

No Open Roles At This Time

QC Data Reviewer

The primary role of the QC Data Reviewer is to perform peer data review QC and AR&D analytical data to support GMP manufacturing and process development. The QC Data Reviewer will review raw data, laboratory notebooks, logbooks, forms, protocols, reports, etc.

Job Responsibilities

1. Perform detailed peer review of analytical data to ensure correctness, accuracy, data integrity, and compliance.
2. Perform all work in a safe and compliant manner in accordance with EHS best practices and cGMP guidelines.
3. Assist with sample management, supply inventory, housekeeping, and other lab maintenance and support activities as assigned.
4. Prepare standard operating procedures (SOPs), protocols, reports, specifications, labels, certificates, etc. as needed.
5. Assist senior management with audits, inspections, OOS, risk assessment, and root cause investigations.
6. Write deviations, change controls, and CAPAs, and/or assist senior management with these documents.
7. Review analytical protocols & reports for method transfers, qualifications, and validations in GMP setting.
8. Other duties as assigned.

Required Knowledge, Skills and Abilities  

• Hands-on experience with various analytical techniques, including LC, GC, LC-MS, spectroscopy, electrophoresis, KF, endotoxin, ELISA, etc.
• Extensive knowledge and experience in cGMP, data integrity, ICH guidelines, USP, and Ph.Eur.
• Excellent written and oral communication skills.
• Analytical mindset, critical thinking skills, and attention to detail
• Proficient in various data acquisistion and processing platforms, including Empower and SoftMax.

Job Specifications

Education and Experience Requirements

• BS, MS, or PhD degree in chemistry, biology, biochemistry, or related discipline.
• Experience in a GMP manufacturing or CRO setting.
• BS with at least 3 years of relevant experience, MS or higher degree with at least 2 years of relevant experience, or equivalent combination of work experience, education, and training

Physical Demands

• Typically requires standing and walking for entire shift.
• Occasionally requires lifting of up to 20 pounds
• Frequently requires the use of a step stool
• Requires manual dexterity and visual abilities

Working Conditions

Laboratory and office environment

Certificates & Licenses Required

N/A

 Confirm Job Qualifier To Apply

NJ Bio, Inc. is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to their race, color, sex, religion, age, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability or any other characteristic protected by applicable federal, state, or local laws.

No Open Roles At This Time

No Open Roles At This Time

No Open Roles At This Time

No Open Roles At This Time

No Open Roles At This Time

No Open Roles At This Time

No Open Roles At This Time

If you don’t see a job posting that meets your criteria, please send us your resume through this link.

If you don’t see a job posting that meets your criteria, please send us your resume through this link.