Validation Specialist

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Job Title: Validation Specialist

Summary of Objective:

The Validation Specialist plays a key role in the qualification and validation of medical device assembly

equipment, pharmaceutical packaging equipment, and related processes. Core responsibilities include

generating and executing validation protocols for packaging and assembly equipment, as well as process

validation. The role also involves supporting customer audits and determining validation needs for

customers. The Validation Specialist will manage multiple projects with moderate supervision, ensuring

equipment, processes, and systems meet regulatory requirements and pre-defined specifications. This

position requires close collaboration with cross-functional teams to ensure compliance with relevant

regulations (e.g., 21 CFR Part 210/211, ISO 13485) and company policies. A strong emphasis is placed

on hands-on validation activities for equipment and processes.

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.

1. Analyze customer and business needs in determination of a validation strategy.

2. Develop and execute validation plans, protocols (IQ, OQ, PQ, TMV), and summary reports for

equipment, processes, and associated systems.

3. Conduct and/or participate in customer meetings and attend off-site meetings.

4. Collaborate with engineering, operations, quality assurance, customers and other stakeholders to

define equipment and process requirements and acceptance criteria. Interact with Sales, Customer

Service, and Project Management.

5. Contribute to the development and improvement of validation procedures and templates.

6. Review and approve User Requirement Specifications, Functional Specifications and Engineering

Study Protocols

7. Participate in customer audits and annual product reviews

8. Prepare Equivalencies and Stability protocols

9. Review and possibly assist in Factory Acceptance Tests (FAT) and Site Acceptance Tests (SAT)

to qualify equipment

10. Assist in the Change Control process

11. Conduct testing activities, including installation qualification (IQ), operational qualification (OQ),

and performance qualification (PQ) for equipment and processes. This will include hands-on

execution of protocols.

12. Coordinate validation efforts with mechanics, operators, and engineering.

13. Maintain validated equipment and processes in a state of compliance through periodic reviews, re-

validations, and change control procedures.

14. Responsible for the administration, implementation, and project management of assigned projects,

including using standardized methodology.

15. Manage multiple validation projects concurrently, ensuring timely completion and adherence to regulation compliance. May include some project leadership responsibilities for specific validation efforts. 16. This position may require occasional overtime and/or weekend work. 17. Performs other duties as assigned by Manager/Supervisor.

Special Demands: 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 1/4 to 1/2 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: None.

- Ascend/Descend or Work Atop: None.

- Position self (to) or Move (about or to): None.

- Communicate or exchange information: From 1/4 to 1/2 of the day.

- Detect, distinguish, or determine: None.

On an average day, the individual can expect to move and/or transport up to 10 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 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.

Work is performed in areas with moderate risk or discomfort that may require special safety

precautions, such as wearing protective clothing or gear for 1/4 to 1/2 of the day.

Work is primarily performed at a desk and/or in an office environment. for 1/4 to 1/2 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: Education: Bachelor's degree in engineering, life sciences, pharmaceutical sciences, or related field. Experience: At least 3 years of experience in validation, quality assurance, or a related role in the pharmaceutical or biotechnology industry, preferably within a CDMO environment. Experience with validating processes, equipment, utilities, and computerized systems in a GMP-regulated environment. Experience with development and execution of validation protocols for process, equipment, cleaning, and/or computer systems in the pharmaceutical and/or medical device industry. Strong understanding of relevant regulations and guidelines (e.g. 21 CFR Part 210/211, ISO 13485, GAMP 5). Proficiency in writing and executing validation protocols and reports.

Preferred: Knowledge of Six Sigma, DOE, and other improvement

Join us and be part of building the bridge between life changing therapies and patients. Let's talk future

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.

At PCI, Equity and Inclusion are at the core of our company's purpose: Together, delivering life-changing therapies. We are committed to cultivating an inclusive workplace by holding ourselves accountable to the highest standards of understanding, fairness, respect, and equal opportunity - at every level. We envision a PCI community where everyone can belong and grow, and we strive to bring this vision to reality by continuously and intentionally assessing our people practices, policies and programs, marketing approach, and workplace culture.