Validation and Facilities Specialist II

Validation and Facilities Specialist II

At Minaris Regenerative Medicine our vision is creating future cell therapy miracles together. We are a leading global contract development and manufacturing organization dedicated to the advancement of cell and gene therapy products. We believe in the transformative potential of cell and gene therapies and we are shaping the future of medicine. We open doors in the regenerative medicine industry for those looking to transform medicine while continuously improving an innovative, growing company.

The Validation and Facilities Specialist II performs validation activities including development and execution of equipment protocols, assessments, specifications, and final reports for IQ, OQ and/or PQ of basic cell processing QC lab equipment and facility. This role is also responsible to provide technical support to the facility systems by monitoring, and responding to specific equipment, environmental monitoring, and related facility alarms, troubleshooting of all problems as they occur on all equipment including but not limited to HVAC systems, Incubators, Cold Rooms/Freezers, and other equipment in the Facility. The ideal candidate exercises judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions.

Essential Functions and Responsibilities

Prepare IQ/OQ and /or PQ protocols for various Cell Therapy manufacturing process equipment and QC test equipment such as Flow Cytometers, Cell Separators, Centrifuges, Cell processing equipment, clean utilities, Bioreactors, Automated Control Systems, etc.

Execute IQ/OQ and /or PQ protocols.

Prepare final reports and traceability matrices for executed protocols.

Prepare necessary supplemental documents and final reports for vendor IQ, OQ and/or PQ protocols, including user/design/functional specifications.

Review of executed IQ/OQ/PQ protocols and raw data.

Perform periodic review/requalification of validated equipment, systems, and cleanrooms.

Manage assigned projects (with supervision) to completion in accordance with established timelines, following-up on review/approval cycles to ensure deadlines are met.

Maintain validated status of the facility.

Perform maintenance activities on equipment and facility by coordinating and documenting all work as performed according to Good Manufacturing Practices (cGMP), Good Documentation Practices (GDP), and Company SOP’s. Provide ongoing insight to Supervisors where SOP’s and policies need to be updated.

Monitor and respond specific to equipment, environmental monitoring, and related Facility Alarms as per site SOPs.

Perform Change Controls, CAPA actions, Asset management activities, deviation initiation/assessment/closure as assigned.

Support Functions and Responsibilities

Support inspection readiness as required.

Collaborate with peers and other Minaris RM sites to align processes and procedures and, implement process improvements.

Support diagnosis and mitigation activities of the issues associated with electronic, mechanical, and electrical components of the facility.

Coordinate with vendors and peer groups in support of validation projects.

Review contractors physical work and paperwork for technical accuracy and comply with cGMP, GDP, and Company SOP’s.

Qualifications

Minimum BS/BA in engineering or a related Science discipline and 2-5 years of validation/GxP experience with facility experience preferred.

Good computer skills and Microsoft Office knowledge.

Must have a thorough knowledge of cGMP and regulatory requirements, including an intermediate amount of knowledge of 21 CFR Part 11 requirements.

Technical skills to perform validation activities (use of validation instruments such as Kaye Validator, Lives Remote Sensors, Tachometer, Multimeter, etc.) and facilities activities with tools such as Vaisala, Maximo, and Building Management Systems.

At least one moderately developed knowledgebase (a developing expertise) in a validation / facilities area/discipline.

Competencies/Candidate Profile

Excellent protocol and report writing skills, excellent oral and written communication skills, detail orientation, problem solving skills and ability to work independently as well as in a team setting are necessary.

Must be a dedicated self-starter with a positive aptitude to achieve results.

Must have strong critical thinking skills, with a track-record of successful issue resolution.

Good time management skills to manage and meet deadlines.

Strong collaborative and influencing skills and ability to work well in a cross-functional, team environment.

Ability to multi-task is essential.

Flexible and able to adapt to company growth and evolving responsibilities.

Available to respond to facility alarms.

Minimum Required Training

GMP Training

Supervisory Responsibilities

This job has no supervisory responsibilities.

Working Environment

May occasionally work with sealed-packaged blood bags and are expected to utilize universal precautions with all human specimens, though breaching the bag is not expected. Other exposures may include gases (nitrogen), or corrosive chemicals (Clorox, potassium hydroxide), or exposure to liquid nitrogen. The noise level in the work environment is typical office noise level 70% of the time, and cleanroom noise level 30% of the time.

Must have the ability to work in a team-oriented environment.

Must be able to work during the weekend, holidays, off shifts and as required by the company.

Must have the ability to work with specialized equipment.

Must utilize proper personal protective equipment (PPE) when handling all human specimens, gases, corrosive chemicals, and liquid nitrogen.

Ability to work on ladders, work from heights, work in small crawl spaces, work outdoors in all weather conditions.

This role operates within a professional office environment of a manufacturing operations plant. This role routinely uses standard office equipment such as computers, phones, photocopiers, filing cabinets, and fax machines. Seating is mixed and includes open space seating, cubicle, and office space.

Physical Requirements

The physical demands described here represent those that must be met by an employee to perform the essential functions of the job successfully.

Ability to lift, transfer, or ship validation equipment or related accessories up to 30 pounds.

An individual may occasionally exert up to 30 pounds of force or a negligible amount of force frequently to lift, carry, push, pull, or otherwise move objects. Sedentary entails sitting most of the time but may involve walking or standing for brief periods.

Must be capable of moving, sitting, stretching, stooping, reaching with hands and arms, and have vision sufficient to read materials.

Must be capable of using hands and fingers to operate a computer and other office productivity machinery such as copy machine, printer, and calculator.

Must have the ability to communicate information and ideas so others will understand. Must be able to exchange accurate information in person, and on the telephone.

Other Duties

Assembling validation related documents; and filing/archiving approved documents.

Maintaining electronic records.

Disclaimer

The above information in this description is intended to describe the general nature and level of work performed. It does not contain nor is it intended to be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees assigned to this job. Duties, responsibilities, and activities may change at any time with or without notice.