Job Description

Job Description

Job Description

About Ocyonbio:

Ocyonbio is a biotechnology company based in Aguadilla, Puerto Rico, dedicated to propelling

the future of healthcare. We provide cGMP spaces that can be customized to meet unique

requirements and services to help catalyze the development, manufacturing, and

commercialization of biologics, genetic, and cellular therapies. We behave more like a cGMP

incubator space with all regulatory, systems capabilities, and resources to enable CMC data to

support regulatory applications.

We strive to create a space free of both explicit and implicit discrimination and harassment

where everyone feels safe, heard, and valued. The character of our employees is as important as

their talent, and we are proud of the team and environment we are assembling as we grow.

Place of Performance: CII George Sanders, Aguadilla Pueblo, Aguadilla P.R. 00603.

Job Overview:

We are seeking a seasoned Asset Management Manager to join our team. The candidate will

oversee the calibration and maintenance of the manufacturing facility, utilities, laboratory, and

production equipment to ensure optimal performance and compliance with regulatory standards.

The successful candidate will possess a strong background in asset management and metrology

within the biopharmaceutical industry, along with excellent management skills and a keen

attention to detail.

Key Responsibilities:

• Develop and implement asset management strategies to optimize asset usage and achieve

company objectives.

• Oversee the life cycle of assets, including acquisition, maintenance, and

decommissioning or disposal.

• Ensure compliance with company policies and regulatory guidelines in relation to asset

management.

• Leads the manufacturing and utility systems reliability and metrology programs required

to achieve the company's manufacturing performance goals.

• Troubleshoots routine and unusual problems and ensures proper spare parts inventory is

available in the stock room.

• Lead the implementation of ProCal for the facility.

• Establishes key performance metrics which monitor and assist the team in understanding

maintenance services performance.

• Manages Maintenance-related Exception Reports (e.g., Quality Investigation Reports,

CAPA, Change Controls, etc.), assuring compliance with Federal and Local Regulatory

Agencies (e.g., OSHA, EPA, FDA, DEA, etc).

• Participates in regulatory audits as SME (Subject Matter Expert) and assures areas of

responsibility readiness in preparation for Regulatory Agencies' audits.

• Work with various departments to understand equipment needs and manage asset

allocation.

• Develop and manage the asset register, ensuring accurate tracking of all company assets.

• Oversee all metrology operations, including the calibration, preventative maintenance,

and repair of laboratory and production equipment.

• Develop, implement, and manage metrology policies, procedures, and schedules to

ensure compliance with internal requirements and external regulations.

• Provide training to staff on metrology procedures and practices.

• Participate in regulatory inspections and audits related to metrology.

Qualifications:

• Bachelor's degree in Engineering, Science, or a related field. A master's degree or

relevant certification is preferred.

• A minimum of 7 years of experience in metrology within the pharmaceutical or

biopharmaceutical industry.

• Strong knowledge of ProCal.

• Extensive knowledge of metrology practices and principles, and regulatory standards like

FDA, EMA, and ISO.

• Proven experience in managing technical teams.

• Strong problem-solving, decision-making, and project management skills.

• Excellent written and verbal communication skills.

What we offer:

• Competitive salary (DOE (Design of Experiments).)

• Health, dental, and vision benefits.

• Professional training and development opportunities.

• Opportunities to participate in the company stock options program

Working conditions:

Physical Requirements

OFFICE POSITION - While performing the duties of this job the employee is required to:

• Stand, sit; talk, hear, and use hands and fingers to operate a computer and telephone

keyboard reach, stoop kneel to install computer equipment.

• Specific vision abilities required by this job include close vision requirements due to

computer work.

• Light to moderate lifting is required.

• Moderate noise (i.e., business office with computers, phones, printers, traffic light).

• Ability to sit at a computer terminal for an extended period. Sedentary work Exerting up

to 10 pounds of force occasionally and/or a negligible amount of force frequently or

constantly to lift, carry, push, pull, or otherwise move objects, including the human body.

Sedentary work involves sitting most of the time. Jobs are sedentary if walking and

standing are required only occasionally, and all other sedentary criteria are met.

We Are An Equal Opportunity Employer

Ocyonbio provides equal employment opportunities to all employees and applicants for

employment and prohibits discrimination and harassment of any type without regard to race,

color, religion, age, sex, national origin, disability status, genetics, protected veteran status,

sexual orientation, gender identity, or expression, or any other characteristic protected by federal,

state or local laws.

This policy applies to all terms and conditions of employment, including recruiting, hiring,

placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation, and

training.

To learn more about us, please visit our website:

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