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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 Title:

Validation Engineer I

Location:

Bedford, New Hampshire

Business Type:

D&M

Department/Function:

Validation

Reports to:

Validation Manager

FLSA Status:

Exempt

Prepared By:

Hiring Manager

Approved By:

Human Resources

Date:

15JUL2025

Summary of Objective:

Under the guidance and mentorship of senior level Validation Engineers and management, the Validation Engineer I will execute an array of well-defined validation activities in support of cGMP pharmaceutical/medical device contract manufacturing across multiple PCI facilities. The Validation Engineer assists internal project teams and external validation firms on validation/qualification initiatives to ensures project schedules are met. Complies with requirements of the Safety Program, including PCI Health and Safety mandates and OSHA requirements. In carrying out duties, contributes and promotes a positive and equitable working environment emphasizing the PCI Values: Customer Focus, Innovation, Integrity, Collaboration, and Superior Performance.

**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.

• Perform administrative activities such as data entry into Validation scheduling tools, scan validation documents, and file validation documents

• Execute Test Protocols, including identification and resolution of non-conformances/deviations.

• Assist with test protocols for installation, operation, performance of equipment, and IQ/OQ/PQ.

• Under the direction of senior level validation engineers and manager execute validation related activities IQ/OQ/PQ for (Facilities, equipment, utilities, processes, and materials)

• Work closely with other validation department personnel as well as cross-functionally with Manufacturing, Engineering, Critical Utilities, Quality Assurance, and project management to schedule validation deliverables.

• Coordinate and work on Validation deviations and participates in deviation investigations to identify root causes and define corrective and/or preventative actions (CAPA).

• Collaborate and propose corrective actions to validation manager to implement the required changes.

**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.

• Ability to lift 50 pounds

• Must be able to stand for long periods of time each day

• Travel and work at all PCI site locations/facilities

• Able to don ISO cleanroom gowning and PPE, as required by site procedures.

**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.

+ undefined

+ undefined **_TRAVEL –_** None

**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.

+ Experience in pharmaceutical or biopharmaceutical environment in operations/engineering/manufacturing/quality environments.

+ Combination of equipment qualification, process validation, or cleaning validation is acceptable; QA pharmaceutical experience also preferred.

+ Associate/Bachelor’s degree in Engineering or related scientific discipline with 1-3 years of Pharmaceutical industry experience or combination of work experience in Validation, QA, MFG, or Engineering.

+ Knowledge of Industry guidelines (ISPE, PDA), US and international regulations (FDA, ICH, ISO, EMA) for validation of GMP facilities.

+ Possess functional knowledge of commissioning, qualification validation, practices, including applicable regulations.

+ Strong technical writing, verbal communication and presentation skills.

+ Proficiency in Microsoft Office including Word, Excel, Power Point, Project

+ Organized individual who is accustomed to working in a result oriented-focused, dynamic CMO environment.

+ Professional and collaborative team player must have strong interpersonal skills.

+ Honesty, integrity, respect and courtesy with all colleagues.

+ Self-motivated and able to meet goals following the input and guidance of management as well as from more experienced Validation Engineering team members.

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.

Join us and be part of building the bridge between life changing therapies and patients. Let’s talk future (https://pci.com/)

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._

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