(Sr.) Engineer Technician

ProBio; Pennington (NJ); On-site; USD 85,000 - 105,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

401(k) retirement plan with company-mâ

Paid parental leave

Paid time off

Job summary

ProBio seeks an Engineering Technician to manage and improve manufacturing and laboratory equipment in a GMP environment. The role covers preventative and corrective maintenance, calibration, and documentation, with cross-functional coordination to resolve issues.

You will support start-up, commissioning, and turnover of new systems, and maintain critical clean utilities and water systems to ensure compliant operations.

Qualifications

• High School Diploma or GED with 5+ years in facilities maintenance in pharma/biotech.
• Strong knowledge of cGMP, GXP, and related regulatory practices.
• Experience with CMMS and calibration documentation.
• Proficient in MS Office and good written/verbal communication.
• Ability to lift up to 50 lbs and work in diverse environments.

Responsibilities

• Maintain and calibrate GMP/non-GMP equipment, ensuring proper documentation.
• Support troubleshooting, test, repair, and optimization of instruments and control systems.
• Contribute to maintenance program improvements and calibration standards.
• Assist start-up, commissioning, and turnover of new systems.
• Maintain water systems, WFI, clean utilities, and related piping.
• Keep refrigeration, fridges, freezers, and related systems in good order.

Skills

cGMP knowledge

CMMS proficiency

Microsoft Office

Clear communication

Physical ability

Cross-functional collaboration

SDLC familiarity

Problem solving

Refrigeration tech background (plus)

Education

High School Diploma or GED

Tools

CMMS

MS Office

GMP software tools

Job description

ProBio, a subsidiary of GenScript, is a global CDMO offering end-to-end services from discovery to GMP for plasmids, antibodies, and cell & gene therapies. We bring together multidisciplinary expertise to accelerate development and manufacturing through customized, and comprehensive services. ProBio has established companies in the United States, the Netherlands, South Korea, and China (Hong Kong, Shanghai, and Nanjing) and other regions to serve global customers, and has helped customers in the United States, Europe, Asia Pacific and other regions obtain more than 150 IND approvals since October 2017.

Position Overview:

The Engineering Technician is responsible for the manufacturing and laboratory equipment at the site. This includes performing activities and overseeing outside vendor activities required to support the Preventative Maintenance and Corrective Maintenance program in accordance with Good Manufacturing Procedures (GMP) regulations and company Standard Operating Procedures (SOPs). This includes ensuring that these activities are properly documented.Instrument services may be performed in but not limited to GMP, Good Lab Practices (GLP), Non-GMP process and laboratory areas.The incumbent works cross-functionally with internal departments and external resources as appropriate on maintenance and repair-related issues.

Responsibilities:

• Maintains and performs corrective and preventative maintenance and calibrations on GMP and non-GMP equipment.
• Supports other departments to troubleshoot, test, repair and optimize instruments, equipment and control systems.
• Participates in the continuous improvement efforts within the site Maintenance Program.
• Assists in the maintenance and review of calibration standards and vendor calibration documentation.
• Provides support for start-up, commissioning, and turnover of new systems.
• Perform preventative and predictive maintenance on related clean utilities and systems that support Process Manufacturing.
• Maintains water rooms and related equipment. This includes, but may not be limited to, pumps, motors, Deionized Water System, WFI stills, Clean Steam Generators and related piping.
• Maintains all site refrigerators and freezers.
• Troubleshoots and repairs all related clean utility equipment and systems and Water for Injection (WFI) point of use flushing.
• Maintains documents and records on all validated equipment and systems.
• Interfaces with other departments, contractors and disciplines on scheduling repairs and maintenance of clean utility systems.
• Maintains up to date training records.
• Communicates with management regarding change documentation, as necessary.
• Follows current Good Manufacturing Practices (cGMPs).
• Communicates and coordinates with each department and within Facilities Management when planned and unplanned work events occur.
• Perform additional job duties as required.

Qualifications:

• High School Diploma (or GED) with a minimum 5 years of facilities maintenance/operations experience in a pharmaceutical, biotechnology or related environment OR the equivalent combination of education and experience. Advanced knowledge of Preventive Maintenance and calibration disciplines within a cGMP Biotechnology, Pharmaceutical or related manufacturing environment.
• Knowledge of cGMP, GXP, Good Automated Manufacturing Practice (GAMP), Software Development Life
• Cycle (SDLC) regulations, knowledge of pharmaceutical, manufacturing and laboratory systems and equipment.
• Proficiency with Computerized Maintenance Management Systems (CMMS).
• Proficiency with Microsoft Office.
• Excellent verbal and written communication and skills.
• Ability to lift up to 50 lbs. and work in confined spaces, heights, and varying environmental conditions.
• Must be able to stand, walk, bend, and climb ladders for extended periods.
• Ability to read and interpret documents such as safety rules, operating and maintenance instructions, and procedure manuals.
• Ability to write routine reports and correspondence.
• Ability to work holidays and varying shift times/hours if required.
• Must be able to respond to site emergencies .
• Ability to work independently and collaboratively, as required, in a fast-paced, matrixed, team environment consisting of internal and external team members.
• Analytical thinker with excellent problem-solving skills and the ability to adapt to changing priorities and deadlines.
• Excellent planning, organization and time management skills including the ability to support and prioritize multiple projects.
• Refrigeration Technician background a plus but not required.

Pay range is estimated between $85k - $105k based on skill set and experience.

#AH

Benefits include medical, dental, and vision insurance as well as a 401(k) retirement plan with a company match that vests fully on day one. We offer paid parental leave after just three (3) months of employment, and a paid time off policy that includes vacation time, personal time, sick time, floating holidays, and company holidays. Additional benefits include flexible spending and health savings accounts, life and AD&D insurance, short- and long-term disability coverage, legal assistance, and supplemental plans such as pet, critical illness, accident, and hospital indemnity insurance. We also provide commuter benefits, well-being initiatives, and peer-to-peer recognition programs; demonstrating our ongoing commitment to building a culture where our people feel empowered, supported, and inspired to do their best work.

ProBio Inc. is a proud equal opportunity/affirmative action employer committed to attracting, retaining, and maximizing the performance of a diverse and inclusive workforce. It is the Company's policy to ensure equal employment opportunity without discrimination or harassment based on race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity or expression, age, disability, national origin, marital or domestic/civil partnership status, genetic information, citizenship status, uniformed service member or veteran status, or any other characteristic protected by law.

ProBio Inc. maintains a drug-free workplace.

Please note: ProBio Inc. will only contact candidates through verified application sources. Probio does not request personal information from candidates through individual email or any other platform.

Voluntary Self-Identification

For government reporting purposes, we ask candidates to respond to the below self-identification survey.Completion of the form is entirely voluntary. Whatever your decision, it will not be considered in the hiringprocess or thereafter. Any information that you do provide will be recorded and maintained in aconfidential file.

As set forth in ProBio’s Equal Employment Opportunity policy,we do not discriminate on the basis of any protected group status under any applicable law.

If you believe you belong to any of the categories of protected veterans listed below, please indicate by making the appropriate selection.As a government contractor subject to the Vietnam Era Veterans Readjustment Assistance Act (VEVRAA), we request this information in order to measurethe effectiveness of the outreach and positive recruitment efforts we undertake pursuant to VEVRAA. Classification of protected categoriesis as follows:

A "disabled veteran" is one of the following: a veteran of the U.S. military, ground, naval or air service who is entitled to compensation (or who but for the receipt of military retired pay would be entitled to compensation) under laws administered by the Secretary of Veterans Affairs; or a person who was discharged or released from active duty because of a service-connected disability.

A "recently separated veteran" means any veteran during the three-year period beginning on the date of such veteran's discharge or release from active duty in the U.S. military, ground, naval, or air service.

An "active duty wartime or campaign badge veteran" means a veteran who served on active duty in the U.S. military, ground, naval or air service during a war, or in a campaign or expedition for which a campaign badge has been authorized under the laws administered by the Department of Defense.

An "Armed forces service medal veteran" means a veteran who, while serving on active duty in the U.S. military, ground, naval or air service, participated in a United States military operation for which an Armed Forces service medal was awarded pursuant to Executive Order 12985.