Title: Laboratory Equipment Qualification Specialist Location: Barceloneta, Puerto Rico (100% On-Site) Contract Length: 6+ Months (Full-Time) Company Description: Join a dynamic team at a leading small molecule contract manufacturing organization in Barceloneta, Puerto Rico. Our client specializes in a wide range of pharmaceutical manufacturing capabilities, including massing, granulation, direct compression, hot melting extrusion, bi-layer tablets, tablet coating, capsules, particle coating, and liquids. Position Summary: We are looking for a highly motivated and detail-oriented Laboratory Equipment Qualification Specialist to join our client team in Barceloneta. The successful candidate will be responsible for ensuring the qualification and optimal performance of critical laboratory equipment, adhering to strict GMP/GLP guidelines and client's quality standards. This role requires a strong understanding of validation processes, technical documentation, and the ability to work collaboratively in a fast-paced biotechnology environment. Key Responsibilities: Equipment Qualification and Validation:

• Develop and execute qualification protocols (IQ, OQ) for various laboratory instruments, including but not limited to those used in chemical analysis (GC, HPLC, analytical balance, density meter, etc.).

• Perform risk assessments, system classifications, and develop validation plans.

• Prepare comprehensive qualification reports and documentation packages.

• Manage the decommissioning and change plans for laboratory equipment.

  Regulatory Compliance:

• Ensure all qualification activities comply with GMP, GLP, USP, and other relevant regulatory requirements.

• Maintain accurate and up-to-date documentation according to Client's standards.

• Stay current with industry trends and regulatory changes related to equipment qualification.

  Technical Support and Troubleshooting:

• Provide technical support for laboratory equipment and assist in troubleshooting equipment malfunctions.

• Perform calibration and maintenance of laboratory instrumentation.

• Manage interactions with external vendors for equipment maintenance and support.

  Documentation and SOPs:

• Develop and maintain Standard Operating Procedures (SOPs) related to equipment qualification and maintenance.

• Prepare and review technical reports and documentation.

• Development of documentation packages including original format documents, approved documents, and applicable drawings.

  Data Integrity and Quality Control:

• Ensure data integrity principles are applied throughout the qualification and operation of laboratory equipment.

• Participate in quality audits and contribute to continuous improvement initiatives.

• Perform raw material analysis.

  QUALIFICATION:

• Strong understanding of GMP, GLP, and USP requirements.

• Proven experience with IQ/OQ protocols and validation processes.

• Proficiency in using analytical instruments such as GC, HPLC, FTIR, and others.

• Excellent technical writing and documentation skills.

• Strong problem-solving and analytical abilities.

• Experience with software systems like Maximo, OneVault, SOLTraq, and Kneat is a plus.

• Strong experience with method validation.

• Experience with CAPA and Non-Conformance.

• Puerto Rico Chemical license

  EDUCATION:

• Bachelor's degree in chemistry, Biology, Engineering, or a related scientific discipline.

• Minimum of 5 years of hands-on experience in laboratory equipment qualification, preferably within the pharmaceutical or biotechnology industry.

  Abou t RCM: RCM is a leading provider of Business, IT, and Engineering Services to over 1,000 clients in the commercial marketplace. RCM partners with clients to define, implement and manage a broad range of technologies across multiple platforms, systems, and networks. Our broad geographic presence ensures that a proven and reliable tactical and strategic capability is available and deployable virtually everywhere in North America. Equal Opportunity Statement: RCM is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to age, race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran. Pay Transparency: RCM believes in transparency and fairness in compensation. We are committed to providing our employees with competitive salaries that reflect their skills, experience, and contributions to our organization. As part of our commitment to pay transparency, we want to provide you with as much information as possible about our compensation practices. Disclaimer: This job posting is intended to describe the general nature and the level of the work to be performed. It is not intended to include every job duty and responsibility specific to the position. RCM reserves the right to amend and change responsibilities to meet business and organizational needs as necessary.