Manufacturing Equipment Validation (CQV) Full Time Contract - Four (4) months Location: Barceloneta, PR (On-site) Company Description: Our client Barceloneta PR sites specialize in small molecules and biologics manufacturing. This means they produce a wide range of medications, from traditional tablets and capsules to complex biologics like antibody drug conjugates. Position Description The Manufacturing Equipment Validation (CQV) plays a crucial role in ensuring the integrity and compliance of manufacturing equipment at the client site in Barceloneta, Puerto Rico. This position focuses on evaluating existing and new equipment, with a strong emphasis on data integrity, to meet regulatory requirements (e.g., 21 CFR Part 11, EU Annex 11) and client quality standards. The specialist collaborates with cross-functional teams to assess equipment suitability, identify potential data integrity gaps, and recommend corrective actions. RESPONSIBILITIES: + Equipment Evaluation: Conduct comprehensive evaluations of manufacturing equipment, assessing design, functionality, performance, data acquisition, storage, retrieval systems, qualification documentation (IQ/OQ/PQ), data integrity risks, and data security measures. + Regulatory Compliance: Ensure compliance with data integrity regulations and guidelines (e.g., 21 CFR Part 11, EU Annex 11, GAMP 5). + Data Integrity Strategy: Collaborate with teams to develop and implement data integrity strategies for manufacturing equipment. + Data Integrity Assessments: Develop and execute data integrity assessments and audits of existing equipment. + Corrective Actions: Identify and document data integrity gaps, recommending CAPAs. + Documentation & Training: Support SOP development related to data integrity and provide training on data integrity principles. + Investigations & Reporting: Participate in data integrity deviation investigations, support root cause analysis, and prepare reports on evaluations and assessments. QUALIFICATIONS: + Data Integrity Expertise: Strong understanding of data integrity principles, software, tools and regulatory requirements (e.g., 21 CFR Part 11, EU Annex 11, GAMP 5). + Equipment Evaluation Skills: Experience evaluating manufacturing equipment and systems, including data acquisition, storage, retrieval, and qualification (IQ/OQ/PQ). + Data Security Knowledge: Familiarity with data security measures and best practices. + Analytical Skills: Excellent analytical and problem-solving skills. + Communication Skills: Strong communication and interpersonal skills, with the ability to work effectively in cross-functional teams. + GMP/GDP Knowledge: Experience with GMP and GDP regulations. EDUCATION: + Bachelor's degree in Engineering, Computer Science, or a related scientific discipline with minimum experience of 5 years in a similar role within the pharmaceutical/biotechnology industry, preferably at a large-scale manufacturing facility. 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. About 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.