Medasource
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Position: Validation lead
Location: Holly Springs, NC ( 4130 Frendship Rd, Apex, NC 27539 )
Contract Duration: 6 month contract with likelihood of extension
Start Date: TBD
Key Responsibilities:
- Develop, review, and approve Qualification Protocols (IQ, OQ, PQ), Validation Master Plans (VMPs), User Requirement Specifications (URS), and other related documentation.
- Lead and manage the Commissioning, Qualification, and Validation (CQV) of systems, equipment, and manufacturing processes within a GMP environment.
- Perform and oversee risk assessments, impact analyses, and validation gap analysis to ensure the integrity and consistency of manufacturing processes.
- Support the qualification of equipment, utilities, and facilities, ensuring systems are designed, installed, and validated to meet GMP standards.
- Lead and execute process validation activities for critical manufacturing systems, including equipment, cleaning, and process qualification
- Collaborate with cross-functional teams, including Engineering, Quality Assurance (QA), and Manufacturing, to ensure effective implementation of validation strategies.
- Lead and support regulatory audits and inspections,
- Investigate deviations, conduct root cause analysis, and ensure CAPA activities are in place to address any qualification or validation issues.
Qualifications:
- Strong understanding of GMP, FDA regulations, ICH guidelines, and industry best practices related to qualification and validation.
- 10+ years of experience in C&Q and Validation within a GMP-regulated industry (pharmaceutical, biotech, medical devices).
- Expertise in drafting and executing qualification protocols (IQ, OQ, PQ) and validation documentation (VMPs, URS, etc.).
- Experience with risk assessments, impact assessments, and regulatory compliance audits.
- Strong analytical, organizational, and communication skills.
- Bachelor’s degree in Engineering, Life Sciences, or a related field (Master’s preferred)
For over 16 years, Medasource has established and maintained relationships that are designed to meet your IT staffing needs. Whether it’s contract, contract-to-hire, or permanent placement work, we customise our search based upon your company’s unique initiatives, culture and technologies. With our national team of recruiters placed at 21 major hubs around the nation Medasource finds the people best-suited for your business. When you work with us, we work with you. That’s the Medasource promise.
Medasource is an equal opportunity employer that does not discriminate on the basis of actual or perceived race, color, creed, religion, national origin, ancestry, citizenship status, age, sex or gender (including pregnancy, childbirth, lactation and related medical conditions), gender identity or gender expression, sexual orientation, marital status, military service and veteran status, physical or mental disability, protected medical condition as defined by applicable state or local law, genetic information, or any other characteristic protected by applicable federal, state, or local laws and ordinances.
Benefits & Perks:
Medasource offers competitive medical, dental, vision, Health Savings Account, Dependent Care FSA, and supplemental coverage with plans that can fit each employee’s needs. We offer a 401k plan that includes a company match and is fully vested after you become eligible, paid time off, sick time, and paid company holidays. We also offer an Employee Assistance Program (EAP) that provides services like virtual counseling, financial services, legal services, life coaching, etc.
Pay Disclaimer:
The pay range for this job level is a general guideline only and not a guarantee of compensation or salary. Additional factors considered in extending an offer include (but are not limited to) responsibilities of the job, education, experience, knowledge, skills, and abilities, as well as internal equity, alignment with market data, applicable bargaining agreement (if any), or other law.
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