SRG, the leader in the Life Sciences human capital industry, is looking for a full-time permanent Validation Manager to join our client's pharmaceutical manufacturing team in Lenoir, NC. This position is responsible for planning, performing and coordinating validation projects to ensure timely completion as well as overseeing the validation team for equipment and packaging.

WHAT YOU NEED TO HAVE:

• Packaging experience and validation
• Developed procedures and standards
• Has overseen and managed employees
• Expertise in automated equipment, high speed packaging
• Vials, syringes, IV bags
• 8+ years of experience
• Successive growth in career

JOB RESPONSIBILITIES include, but are not limited to:

• Responsible for drafting and providing technical guidance for the validation program, Policies and SOPs and other master documents
• Support Engineering and Manufacturing in the development of critical process parameters and provide technical leadership for deviation investigations
• Analyze data to provide recommendations for improvements in the manufacturing process and equipment
• Assess new and existing processes (including Equipment IOPQ, Process, etc.) against cGMP and requirements for validation
• Develop and implement strategies for equipment IQ/OQ/PQ, process validation, computer system validation and calibration
• Perform functional and process risk assessments in conjunction with Quality and Manufacturing subject matter experts
• Oversee development and execution of validation protocols and review objective evidence for inclusion in validation reports
• Assist with the technical assessment and resolution of deviances and variances that occur during production or validation
• Work with Quality, Manufacturing, Regulatory, and subject matter experts to prepare for FDA and other agency audits
• Ensure site/system validation program meets FDA, ISO and EU requirements

** Only candidates selected to be moved forward in the recruitment process will be contacted by SRG's Recruitment Team to schedule a conversation.

Impellam Group and its brands are equal-opportunity employers committed to diversity and inclusion. All qualified applicants will receive consideration without regard to race, color, religion, gender, sexual orientation, pregnancy or maternity, national origin, age, disability, veteran status, or any other factor determined to be unlawful under applicable law. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application, interview process, pre-employment activity, and the performance of crucial job functions.

If you require additional disability considerations, modifications, or adjustments please let us know by contacting HR-InfoImpellamNA@impellam.com or fill out this form to request accommodations.