Location:

Puerto Rico

Job Overview:

Santisteban & Associates, LLC currently has an open position for a Validation Engineer Specialist. The selected candidate will perform with the engineering and quality department, in the validation of products, equipment or process in the manufacturing and/or packaging areas. Also support pro-field implementations and must have availability to work in different shifts. This is a job of moderate complexity requiring the ability to work and act both independently and under the direction of the Corporate CEO.

The successful candidate must have Validation experience in regulated environment industries such as pharmaceutical, bio-pharmaceutical, or medical devices companies. Generates, executes, reviews, and complete qualification and validation documentation, summary reports and associated data for conformance to regulations, SOPs, specifications, and other applicable acceptance criteria.

Key Accountabilities:

• Strong understanding of FDA validation guidelines
• GMP and regulatory experience with expertise in process validations.
• Experience in writing and executing validation protocols (i.e., DQ, IQ, OQ, PQ).
• Experience qualifying laboratory equipment
• Experience in writing SOP’s
• Experience with Technical Writing preferred.
• Statistical knowledge, DOE and Quality Process Control experience is preferred.
• Project Management knowledge

Basic Qualifications:

Bachelor of Science or Engineering degree preferred. Must have a minimum of two years of experience in the field, preferably in a consulting or large industrial environment. Must speak, read, and write fluent English and Spanish. Willing to travel, available to report to work upon short notice or as required. Must be able to work independently with minimal supervision. Must have strong interpersonal and written communication skills with the ability to effectively interact with all levels of the organization maintaining client confidential information/ethics and corporate core values. Must be proficient in MS Office products. Must be computer literate and capable of learning specialized software packages. Must be able to wear a respirator and other appropriate safety equipment.

Contact Information:

Send your resume and qualifications to: servicedesk@santistebanllc.com

Job Overview
Santisteban & Associates, LLC currently has an open position for an EHS Specialist. The selected
candidate will perform Risk Assessment investigations/report preparation and implementation of
actions based on Environmental Health & Safety regulations requirements. This is a job of
moderate complexity requiring the ability to work and act both independently and under the
direction of the immediate supervisor.
The EH&S Specialist will assist in providing cost effective, state of the art Environmental and
Safety consulting services to our clients. Inspection of working areas, machinery, lab equipment,
raw materials safety requirements, warehousing, logistics and processes to ensure compliance
with state and federal regulations as well as company policies. The client base ranges from
medium to large global companies and government entities.

Key Responsibilities/Accountabilities
• Responsibilities include performing and documenting Risk Assessment Analysis, HAZOP
Reviews, reporting of non-compliant areas/equipment/processes and recommending
corrective/preventative actions and procedures according to the applicable regulatory
requirements.
• Participate in health and safety reviews and audits of lab/operations/materials/equipment
areas and provide follow up tracking of action items to ensure completion of corrective
actions.
• Assist in the development of EH&S training programs and conduct training as needed for
the clients and as directed by the corporate CEO.
• May provide consultation regarding the management, disposal, and documentation of
hazardous, non-hazardous and regulated wastes.
• Prepare written report of findings of IEQ and other investigations and assessments.
• May develop written compliance documents as required by the client to maintain
conformity with OSHA, EPA, DNER, ADS, PR Fire Squad, and other agencies requirements.

Basic Qualifications
Bachelor of Science degree in EH&S or Engineering degree preferred. Must have a minimum of
two years of experience in the EH&S field, preferably in a consulting or large industrial
environment. Must speak, read, and write fluent English and Spanish. Must have a minimum of
30 hours of OSHA training, ASP or CSP Certification preferred. Willing to travel, available to report
to work upon short notice and work weekends and holidays as required. Additional work
experience may be considered in lieu of the degree. Must be able to work independently with
minimal supervision. Must have strong interpersonal and written communication skills with the
ability to effectively interact with all levels of the organization maintaining client confidential
information/ethics and corporate core values. Must be proficient in MS Office products. Must be
computer literate and capable of learning specialized software packages. Must be able to wear a
respirator and other appropriate safety equipment.
Contact Information
Send your resume and qualifications to: servicedesk@santistebanllc.com