About the job
Responsibilities:
- The Validation Manager role will play a key role in managing the validation program ensuring alignment with regulatory expectations. The position will entail building strong cross-functional relationships throughout the organization and translating multiple assumptions into a balanced validation program. The role will lead validation activities supporting manufacturing at Fagron’s manufacturing sites. The role will also require supporting internal/external audits and other lifecycle activities (FAT) as required for the validation program.
- The Validation Manager, will be responsible for drafting and executing cleaning, process validation, utility, process systems and process support systems qualification test work. Preparing validation summary reports for the qualification and validation of systems used in manufacturing. Some travel required.
Summary of Key Responsibilities:
- Manage the development and maintenance of validation program documents including SOPs and Master Plans.
- Lead validation activities supporting manufacturing at Fagron manufacturing sites.
- Design and execute validation studies that are compliant with established procedures and aligned with industry best practices.
- Provide validation support in deviation investigations and change control.
- Expected to manage complex and multiple project objectives.
- Expected to contribute in regulatory filings and inspections.
- Manage project resources to accomplish defined scope of work and company goals.
Set yourself apart
You possess the following qualifications, background and abilities:
- Bachelor’s degree in Science or Engineering with 8-10 years of operational validation experience in pharmaceutical, or biotechnology industry. Master’s degree is a plus.
- Experience in Facility, Equipment and Utility or Cleaning validation is a must (preferably in a multi-product facility). Experience with Process Validation is a plus.
- Experience in supervision of internal reports and contractors are required.
- Demonstrated knowledge of cGMP compliance.
- Excellent written and oral communication skills.
- Working knowledge of Microsoft Office products (Outlook, Word, Excel, PowerPoint).
- Hands-on experience in Commissioning, Qualification, and Validation activities (CQV) to include:
- New facility CQV activities and scheduling
- Process
- Cleaning
- Media filling
- Demonstrated experience in writing and reviewing SOPs and protocols for accuracy, traceability, and compliance.
- Experience in performing and leading validation studies within the pharmaceutical and biotechnology industry.
- Demonstrated ability in problem solving skills and experience applying these skills to resolve technical problems.
Working Conditions & Physical Requirements:
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is regularly required to:
- Experience prolonged sitting, some bending, stooping and stretching.
- Use hand-eye coordination and manual dexterity sufficient to operate a keyboard, photocopier, telephone, calculator, and other office equipment is required.
- Working on ladders.
What’s on offer?
Fagron offers exciting opportunities for personal and professional growth. We provide an open and truly dynamic environment which supports and encourages you to develop your skills and talents.