Validation (CQV) Engineer

Merck & Co.; Raleigh (NC); On-site; USD 70,000 - 90,000; Full time

Benefits offered by this job

100% employer-paid medical, dental, vision

401(k)

Paid time off

Employee Stock Ownership Plan (ESOP)

Discretionary bonus

Job summary

Merck & Co. is seeking a full-time Validation Engineer to support various commissioning, qualification and validation projects throughout the U.S. Candidates will be responsible for conducting risk and impact assessments, generating procedures, and executing qualifications protocols.

The ideal candidate possesses strong organizational skills, communication abilities, and 2-5 years of experience in a GMP facility. Comprehensive benefits including medical coverage, 401(k), and employee stock options are offered.

Qualifications

• Strong organizational skills and excellent communication abilities.
• Ability to adapt to shifting priorities in dynamic work environments.
• Proficiency in industry regulations related to GMP facilities.

Responsibilities

• Conduct risk and impact assessments; establish system boundaries.
• Generate and review standard operating procedures.
• Execute qualifications protocols for various validation tasks.

Skills

Strong organizational skills

Excellent writing and communication skills

Flexibility in dynamic environments

Knowledge of FDA and GMP guidelines

Proficiency in Microsoft Office

2-5 years of CQV experience

Tools

Microsoft Project

Visio

Job description

ValSource is currently looking to identify several Validation Engineer candidates on a full-time basis to support a variety of different commissioning, qualification, validation, and process engineering related projects with our clients throughout each of our regions in the U.S.

Responsibilities

• Collaboratively conduct risk assessments and impact assessments, and establish system boundaries.
• Generate, review, and edit standard operating procedures; review and verify ETOPs.
• Generate and execute protocols for DQ, FAT, SAT, IV OV, IQ, OQ, and PQ.
• Experience with cleaning and sterilization validation of manufacturing equipment.
• Experience with cleaning validation, process and utility systems validation, laboratory systems & equipment, temperature mapping, manufacturing equipment qualification & validation, etc.
• Generate and support troubleshooting and closeout of discrepancies and deviations.
• Address manufacturing equipment, critical and non‑critical utilities, cleaning systems/processes, automation systems, and lab equipment.
• Additional duties may include attendance at client meetings, preparation of project budgets, review of invoices, and any other duties required to control financial and execution related aspects of the project.
• The project leader may be responsible for both direct execution and supervision of field activities.

Requirements

• Strong organizational skills, excellent writing, and communication skills.
• Ability to work independently and in a team environment, interacting with individuals at all levels in an organization and departmental areas.
• Ability to be flexible to address shifting priorities and changes in approach in dynamic work environments.
• Knowledge of industry guidelines (ISPE, PDA) and US and international regulations (FDA, ICH, ISO, EU) for validation of GMP facilities.
• Proficiency with Microsoft Office including Word, Excel, and PowerPoint; Microsoft Project and Visio a plus.
• Two to five or more years of commissioning, qualification and validation (CQV) experience in pharmaceutical, biotech, medical device or related GMP manufacturing environments preferred.
• Prior practical experience at a GMP facility in a Process Engineering, Facilities, or Operations role with skills transferable to CQV duties also considered.

Equal Employment Opportunity

ValSource is an equal opportunity employer. We provide equal employment opportunities to all employees and applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, age, genetic information, military status, or veteran status. We are committed to creating an inclusive environment for all employees.

Authorization

In compliance with federal law, all persons hired will be required to verify identity and eligibility to work in the United States upon hiring/onboarding. ValSource participates in E‑Verify and will provide the Federal Government with your Form I‑9 information to confirm that you are authorized to work in the United States.

Benefits

Full‑time employees are offered a competitive compensation package that includes full benefits (100% employer‑paid medical, dental, vision, short‑ and long‑term disability), 401(k), paid time off (holidays and vacation), continuous training and development, Employee Stock Ownership Plan (ESOP), discretionary bonus, etc.