Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients.

We are PCI.

Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI.

Job Summary:

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 supporting Customer and Regulatory Audit requests, Facilities/Utilities Qualification, Temperature Mapping, 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. This includes support to periodic evaluation of qualified equipment and systems to determine the need for requalification or revalidation.

The successful candidate will be capable of manage multiple projects under limited supervision. Collaborates with and serves as a back up to other Validation team members.

Essential Duties and Responsibilities: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The essential duties and responsibilities include the following but other duties may be assigned. The Validation Specialist will support 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 Validation team and Validation management. Job duties and responsibilities associated with this position include items identified in summary section, including:

• Completion of assigned packaging equipment qualification and product packaging validation
• Environmental Monitoring program support
• Participate in daily team and project meetings and report against validation commitments
• Utilize established validation process, approach, and protocol and report standards
• Use of SmartSheets to manage information, resources, track projects, and deliverables
• Support periodic evaluation, gap assessments and remediation
• Support Regulatory, Customer and Internal Audits
• Collaborate with Validation team and Validation management to identify opportunities for improvement
• Provide peer review for related protocols and reports
• On time completion of assigned CAPAs
• Serve as a back up to other Validation Specialists as needed
• Limited travel may be required (less than 5%)
• This position may require overtime and/or weekend work
• Knowledge of and adherence to all PCI policies/procedures and cGMP regulatory guidance
• On time completion of ComplianceWire training assignments
• Monthly GEMBA walk completion
• On site attendance to work is a requirement

Qualifications: The requirements listed below are representative of the knowledge, skill, and/or ability required for the stated position. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Required:

• Bachelor's Degree in a related field and/or 1-5 years related experience and/or training.
• College Level Mathematical Skills
• Intermediate Computer Skills: Ability to perform more complex computer tasks and has knowledge of various computer programs.
• Full Professional Proficiency: Ability to speak, read, and write fluently and accurately on all levels pertinent to professional needs.
• Very High Reasoning: Ability to define problems, collect data, establish facts, and draw valid conclusions. Be able to interpret an extensive variety of technical instructions in math or diagram form and deal with several abstract/concrete variables.
• High Standard of Report Writing
• Ability to effectively present information to various people as the job requires.
• Ability to identify and resolve problems in a timely manner.
• Ability to adapt to changing work environments

Special Demands: The employee must be physically capable to perform the duties listed below with or without reasonable accommodations which may be made to enable individuals with disabilities to perform the essential functions.

• Stationary Position: From 1/2 to 3/4 of the day.
• Move, Traverse: From 1/4 to 1/2 of the day.
• Operate, activate, use, prepare, inspect, or place: Up to 1/4 of the day.
• Install, place, adjust, apply, measure, use, or signal: Up to 1/4 of the day.
• Ascend/Descend or Work Atop: Up to 1/4 of the day.
• Position self (to) or Move (about or to): Up to 1/4 of the day.
• Communicate or exchange information: 3/4 of the day and up.
• Detect, distinguish, or determine: 3/4 of the day and up.
• On an average day, the individual can expect to move and/or transport up to 50 pounds less than 1/4 of the day.

This position may have the following special vision requirements:

Close Vision Distance Vision Color Vision Peripheral Vision Depth Perception Ability to focus No Special Vision Requirements

Work Environment:

The following are some environmental conditions that one may be exposed to on a daily basis and for various lengths of time.

• Work is primarily performed at a desk and/or in an office environment. for 1/2 to 3/4 of the day.
• Work near moving mechanical parts for 1/2 to 3/4 of the day.
• Work is performed in areas with moderate risk or discomfort that may require special safety precautions, such as wearing protective clothing or gear for 1/2 to 3/4 of the day.
• The noise level in the work environment is typically, moderate.

EQUAL OPPORTUNITY EMPLOYER/VET/DISABLED

Join us and be part of building the bridge between life changing therapies and patients.