Summary Description:

Plans, develop, and implement documentation, procedures, and training necessary for the engineering team, production and quality personnel.

Generation and execution of change controls, validation plans, validation protocols (FAT/SAT/IQ/OQ/PQ/CSV’s), and completion reports.

Provide statistical analysis of the date to support the reports. Develop statistically based sampling plans for in-process and final testing and inspections, and validations.

Review and approve validations and completion reports for new and existing products, processes and equipment.

Troubleshooting equipment/processes that do not perform as intended during validation runs. Recommend process/quality improvements as part of validation runs.

Work with new and existing equipment, processes, utilities, facilities and cleaning validations, to include (but not limited to) Packaging Equipment (e.g. Multivac Machine), freeze-drying, CCA, DIUF, RO/DI, WFI, Pure Steam, SIP Systems, HEPA Filters, chillers, controlled temperature units, and laboratory equipment.

Evaluate, investigate and document non-conformances incidents and/or protocol deviations.

Develops and maintains an effective cross-functional working relationship with plant and corporate Manufacturing, Engineering, Regulatory, and Quality Assurance personnel.

Work on project teams with other internal departments, external vendors, and customers as required.

Assure that existing processes and assigned activities fully comply with regulatory and/or international agencies, such as FDA, ISO, OSHA, EPA, among others. Performs other related duties as necessary.

MINIMUM QUALIFICATIONS on Knowledge, skills, and abilities:

• Knowledge of Packaging components and equipment is highly desirable.

• Knowledge of FDA, BSI, OSHA, EPA, and GMP's and ISO requirements.

• Knowledge in Organizational Excellence and Lean/Six Sigma.

• Ability to lead teams through complex projects and provide departmental technical leadership.

• Must have demonstrated ability to think strategically.

• Able to develop technical documentation such as: Change Controls, Validation Plans, Validation Protocols, Technical / investigation reports, SOP, and others.

• Teamwork oriented and self-starter

• Able to work on different/extended shifts and/or non-working days when required.

• This position requires to work on site.

• Fully bilingual (English and Spanish).

Education and/or experience:

• BS in Science or Engineering, preferably Mechanical, Industrial, Electrical, Chemical, or Biomedical.

• Lean/Six Sigma Green or Black Belt Certification is a plus.

• Experience in validations such as: packaging equipment, manufacturing equipment, laboratory equipment, cleaning, test method, computer systems, shipping, shelf life (aging), sterilization, facilities, clean rooms, and utilities (HVAC, Compressed Air, Water Systems) required.

• Minimum of 5 - 7 years of experience in the medical device and/or pharmaceutical manufacturing environment; with at least five (5) years in a validation engineering position.

Other Requirements:

• **CANDIDATE MUST LIVE IN PUERTO RICO**

• No relocation nor travel expenses.

Job Types: Full-time, Contract

Work Location: In person

Location: Medical Device Industry _ Anasco, PR, USA (On-site)
Schedule: 2nd and 4th shifts
Language Requirement: Bilingual (Spanish/English)
Long Term Contract: one year

RESPONSIBILITIES

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.

1. Inspect labels, pid's and pouches visually to approve packing operations or other operations.
2. Obtains samples, inspect samples to specifications, record inspection data and makes accept/reject decisions based on inspection findings with respect to specifications.
3. Verifies dimensions, cavity measures, pressure, and other specifications of products, using measuring gauges and testing equipment such as optical comparator, micrometer, calipers, go-no-go gauges, pin gauges, microscope, air pressure gauges, and other testing instruments.
4. Follows quality controls inspection criteria in order to release acceptable lots to store or reject lots prior operations for re-work.
5. Reads written specifications, drawings, and procedures such as the Quality Control Inspection Procedures.
6. Fill quality control records, information on shop orders, and maintains other control reports and documentation.
7. Assists in training of new Q.A. Inspectors.
8. Provides G.M.P/ Quality Manual reinforcement and conducts spot audits to manufacturing areas in order to assist production to achieve established goals.
9. May be assigned to different workstations as product needs require.
10. May use jack pallets for handling raw material incoming inspection area.
11. Sets up and performs destructive and non-destructive test on material, parts, or product to measure performance, material characteristics, etc.
12. Maintains quality control records, blueprints, procedures, and other documentation's accurate, updated, and properly organized in files.
13. Assures all control documentation are prepared and attached to the corresponding lots.
14. Assures that all equipment are adequately calibrated and informs Supervisor of any discrepancy.
15. Assures raw material or products released to stores or for sterilization fulfill quality standards.
16. Maintains work area clean and in orderly conditions.
17. Follow Clean Room Rules and Gowning Practices.
18. Must use safety shoes in areas that require it or the required protective equipment of the assigned workstations. This applies to all area where safety shies area required.
19. Maintains control of raw material quarantine area and printed materials, and discrepant materials in store.
20. Works on priority orders when released before others to assure compliance with productions schedules.
21. Assist the supervisor in any other duty as requested.

DESIRED MINIMUM QUALIFICATIONS – Education and Experience
The requirements listed below are representative of the knowledge, skill, and/or ability required for this position.

• High School graduate or equivalent.

• One (1) year experience in a similar position in an FDA regulated manufacturing environment preferred.

• Knowledge of basic math concepts, graphs interpretation, and use of procedures, and inspection methods.

• Knowledge of statistical process control techniques.

• Ability to read, understand drawings and written documents in English.

• Ability to work using testing instruments and manual equipment.

• Ability to be in a standing position for long periods of time.

Other Requirements:

• **CANDIDATE MUST LIVE IN PUERTO RICO**

• No relocation nor travel expenses.

We encourage candidates who meet the qualifications to apply and join our team.

Job Types: Full-time, Contract

Pay: $10.50 per hour

Work Location: In person

Summary Description:

Work from home to start but will move to Hybrid. Worker MUST be able to work on-site in Anasco.

Microsoft office experience required
Workday experience would be nice
Will be working with US/PR recruiters
Must be able to speak fluently in Spanish and English

Responsibilities include:

• Scheduling interviews, debriefs and other meetings (as necessary).

• Effectively communicate with interviewers and administrative assistants.

• Scheduling candidate travel.

• Facilitate background check and monitor progress.

• Understand candidate reimbursement process.

• Maintain interview tracker.

Qualifications, Education and/or experience::

• Two to five years of recruiting coordination experience.

• Ability to take initiative and interact professionally and effectively with senior management, colleagues, and staff at all levels of the organization.

• Ability to maintain highly confidential information.

• Excellent oral, written, and telephone communication skills, essential.

• Ability to handle multiple assignments simultaneously under strict time constraints attention to detail is critical.

• Must have exceptional communication skills (written and verbal) as well as excellent organization skills.

• Associate’s degree preferred.

Other Requirements:

• **CANDIDATE MUST LIVE IN PUERTO RICO**

• No relocation nor travel expenses.

Job Types: Full-time, Contract

Work Location: Hybrid remote in Añasco, PR 00610