Validation Manager, Commercial - PCI Pharma Services

Position Title: Validation Manager, Commercial
Reports to: Director of Validation
Location: Philadelphia, PA
This position is responsible for site packaging equipment qualification and product packaging validation, utilizing established validation process, approach, and protocol and report standards. Also responsible for new product cleaning assessments, cleaning validation, validation of cleaning and sterilization systems, and Environmental Monitoring.
This position provides technical and project support to Validation, Business Unit, Project Management, Engineering, Quality Assurance, and to our Customers to remain in a state of compliance.
The successful candidate will have supervisory responsibilities and be capable of manage multiple projects under limited supervision. Collaborates with and serves as a back up to the Validation Manager, Infrastructure.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
The Validation Manager, Commercial will lead the business beyond of the normal scope of task-based project validation. Knowledge, experience, personal drive, and creativity will motivate this individual to present new ideas to senior management that will affect the direction of the organization over the next years. The job duties and responsibilities associated with this position are as follows:

* Site validation management of packaging equipment qualification and product packaging validation.
* Cleaning and Sterilization system validation
* New product and cleaning validation assessments
* Cleaning Certifications and/or Cleaning Validation, if required
* Environmental Monitoring program management
* Participate in daily business meetings and report against validation commitments
* Coordinate department resources to ensure validation tasks are managed and on track to meet project commitment dates
* Utilizes the established validation process, approach, and protocol and report standards
* Use of SmartSheets to manage information, resources, track projects, and deliverables.
* Innovation of validation processes and tasks
* Participate in global Validation Center of Excellence and harmonization
* Evaluate validation trends in the pharmaceutical and contract packaging industries
* Lead gap assessments and remediation
* Support Regulatory, Customer and Internal Audits
* Collaborate with Director, Validation and Validation Manager, Commercial to evaluate business needs and determine Validation strategy for equipment, processes, cleaning, serialization, etc
* Review and approve Validation templates and validation related protocols and reports.
* Review and approve Requirements Specifications and Engineering Studies
* Support Change Control and CAPA process
* Serve as a back up to the Validation Manager, Infrastructure
* Limited travel may be required (less than 5%)
SUPERVISORY RESPONSIBILITIES:

* Lead a group of up to five or more team members.

EDUCATION OR EQUIVALENT

* Bachelor of Science in Engineering, Science, or Business discipline
* 4 - 8 years relevant experience in equipment, process, computer and/or cleaning qualification/validation
* Packaging, Pharmaceutical, Bio-Pharmaceutical, and/or Medical Device background is preferred
KNOWLEDGE/SKILLS REQUIREMENTS:

* Experience with development and execution of validation protocols for process, equipment, cleaning, and computer systems in the pharmaceutical and/or medical device industry
* Ability to work on multiple projects at the same time
* Ability to meet aggressive timelines
* Good interpersonal/teamwork skills
* Effective communication skills, verbal and written
* Good documentation practices
* Effective at leading project teams and interfacing with customers and other personnel
* Proficient in the use of computer software - Microsoft Windows, Microsoft Word, Microsoft Excel, Microsoft Access, SPC software and Microsoft Power Point
* Must possess and demonstrate motivational and leadership qualities
* Must possess excellent problem solving and analytical skills
* Must be well organized along with being detail and multi-task oriented, formal project management skills desired
* Knowledge and experience in cGMP, FDA regulations and other international regulatory agency regulations
* Knowledge of statistics, Six Sigma, DOE, and other improvement techniques a plus
PHYSICAL DEMANDS:

* Walking, sitting, standing. 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. Must be physically capable to perform the above duties with or without reasonable accommodations which may be made to enable individuals with disabilities to perform the essential functions.
* The employee must occasionally lift and/or move up to 10 pounds.
WORK ENVIRONMENT:

* Some travel (a few days a year) may be required to meet with customers and/or vendors.
* Must be able to properly gown and work in an active packaging operation. Ability to work with other groups to define, prioritize, schedule and complete validation projects so that PCI's and PCI's customers' business goals and compliance standards are achieved.
* The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
* The noise level in the work environment is usually moderate.
Equal Opportunity Employer/Vet/Disabled