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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.

The Validation Analyst I is responsible for the qualification of pharmaceutical packaging equipment, processes, cleaning, facilities/utilities, and/or computer systems. Core functions include management of multiple limited risk validation projects, generation and execution of validation protocols, direct interface with internal/external customers/regulatory agencies, and determination of customer validation needs. Requires the ability to work with other departments to define, prioritize, schedule and complete validation projects such that PCI’s internal/external compliance standards and production targets are achieved. Occasional overtime/weekend work is required.

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.

All Validation Analysts, regardless of Specialization, have the following core duties and responsibilities.

1. “Limited Risk Validation Projects” are generally defined as projects with the following conditions.

a. Business needs of customer/project require standard time commitments.

b. Low level of uncertainty in managing customer expectations.

c. Standard validation approach as documented in the Validation Master Plan. d. Established criteria that are subject to minimal interpretation.

2. Serve as the primary validation representative for assigned projects. Conduct and/or participate in customer

conference calls, customer/regulatory audits and inspections, and face-to-face meetings.

3. Interact with Sales, Project Management, Engineering, Maintenance, Production, Facilities, Information

Technology, Quality Assurance, and external customers to determine requirements for new projects.

4. Review pre-validation documents including, but not limited to, User Requirement/Acceptance Testing,

Factory/Site Acceptance Testing, Engineering Studies, and batch records/packaging instructions.

5. Prepare Validation documents including, but not limited to, protocols, parameter pages, statements, risk

assessments, room/warehouse layouts, final summary reports, and periodic/product reviews.

6. Test equipment and systems for adherence to validation protocols and summarize results.

7. Conduct discrepancy investigations to identify root cause and corrective/preventive actions.

8. Knowledge of and adherence to all cGMP, regulatory, and global policies, procedures, and requirements.

9. Other documentation, assignments, and/or projects as assigned by management.

After basic training, the Validation Analyst will be trained in 1 or more of the following specializations.

1. Equipment Validation Specialization

a. Write/Execute/Summarize equipment qualification protocols for packaging equipment. Maintain

Master Equipment List for executed validations.

2. Process/Cleaning Validation Specialization

a. Write/Execute/Summarize process qualification and cleaning validation protocols for

customer/product combinations. Maintain parameter pages for executed validations.

3. HVAC/Utility Validation Specialization

a. Write/Execute/Summarize qualification protocols for HVAC systems, and utilities supporting primary packaging operations and product/component storage. Analyze temperature/humidity mapping data for product/component storage areas. Maintain Master HVAC Equipment List for

executed validations.

b. Perform periodic reviews of temperature/humidity charts/data and assign follow-up actions as

indicated. Maintain Periodic Review list for completed periodic reviews.

4. Computer Validation Specialization

a. Write/Execute/Summarize qualification protocols for all computer systems software, hardware,

and spreadsheets used in GMP processes. Maintain Validated Computer Systems list for executed validations.

b. Write/Summarize test scripts based upon User Acceptance Testing, equipment/software manuals, and site work instructions.

c. Perform periodic reviews of computer software/hardware systems and assign follow-up actions as indicated. Maintain Periodic Review list for completed periodic reviews.

Special De m ands: 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. 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, act i vate, use, prepare, inspect, or place: From 1/4 to 1/2 of the day.

• Install, place, adjust, apply, m easure, use, or signal: None.

• Ascend/Descend or Wor k Atop: None.

• Position self (to) or Move (about or to): Up to 1/4 of the day.

• Com m unicate or exchange infor m ation: 3/4 of the day and up.

• Detect, distinguish, or deter m ine: From 1/2 to 3/4 of the day.

On an average day, the individual can expect to move and/or transport up to 25 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

Wor k Environ m ent: 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 following are some environmental conditions that one may be exposed to on a daily basis and for various lengths of time.

Ø Work is primarily performed at a desk and/or in an office environment. for 1/2 to 3/4 of the day. Ø Work is performed in areas with moderate risk or discomfort that may require special safety

precautions, such as wearing protective clothing or gear for up to 1/4 of the day.

Ø Work near moving mechanical parts for 1/4 to 1/2 of the day.

Ø Extreme cold (non-weather) for up to 1/4 of the day.

The noise level in the work environment is typically moderate.

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:

• High School Diploma or GED or 1-3 years of related Quality Assurance experience/training.

• Basic Mathematical Skills: Ability to perform basic calculations using common formulas.

• Basic Computer Skills: Able to write, modify, and edit text using word processing applications and sort, apply filters, and use different views on spreadsheet applications.

• Minimum Professional Proficiency: Ability to read technical documents and speak in a way that allows one to participate effectively in various conversations.

• Minimum Reasoning: Ability to apply common sense understanding to carry out instructions that may be furnished in written, oral, or diagram form.

• Average or better typing speed.

Preferred:

• Experience with Project Management, Quality Assurance, and an office environment.

• Proficiency in Microsoft Office (Word, Excel, PowerPoint)

• Equipment/Process/Cleaning Validation Specialization: Background in Packaging, Pharmaceutical, and/or Medical Devices. Must be able to properly gown and work in an active packaging operations.

• HVAC/Utility Validation Specialization: Familiarity with HVAC diagrams, controls, pressure differential,

air quality, and fundamentals of heating, air conditioning, and refrigeration systems.

• Computer Validation Specialization: Ability to perform complex computer tasks and have some experience with computer systems considered to have an impact on cGMP, cGXP, Annex 11.

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Equal Employment Opportunity (EEO) Statement:

PCI Pharma Services is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.

Why work for PCI Pharma Services?

At PCI, we have an uncompromising focus on providing quality and operational excellence and providing the industry leading customer experience. Our people make all of this happen, so providing an industry leading experience for our people is equally as important. By creating an authentic culture of purposeful work, we aspire to be an interesting and fulfilling place for talented individuals to grow careers. We live a philosophy of intentional learning combined with real-life experience supported by a fair and competitive rewards program. We are individuals, teams and a company that believes in our purpose and our approach is simple, the people who work at PCI fuel our business; we don’t say no, we figure out how.

PCI Pharma Services is an Equal Opportunity Employer/Vet/Disabled