Validation Engineer I-Iii

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.

The Validation Engineer II partners with other members of the Validation organization to work and perform an array of well-defined validation activities in support of cGMP pharmaceutical/medical device contract manufacturing across multiple PCI Pharma facilities.

• The Validation Engineer II assists with internal project teams and external validation firms on validation/qualification projects and initiatives and will partner with them to ensure 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.

• Assists and actively contributes to the writing of validation plans; assist with the development of specifications for user requirements, functional requirements, and design requirements, trace matrices, validation summary reports and test protocols for installation, operation, performance of equipment, functional requirements, risk assessments, and IQ/OQ/PQ.

• Review commissioning, qualification, and validation related system lifecycle documentation (user requirements, functional and design specifications, commissioning, and qualification protocols).

• Work in partnership with other validation department personnel as well as cross-functionally with Manufacturing, Engineering, Critical Utilities, Quality Assurance, and project management to achieve all project deliverables, and build strong working relationships.

• Perform risk assessment and mitigation steps to achieve attainment and maintenance of a validated state of compliance for all equipment, utilities, processes, materials, and facilities.

• Coordinate and execute validation protocol activities with consistent and effective communication with affected departments; working autonomously while keeping manager regularly updated.

• Generally, a self-directed role, but may receive guidance from more experienced Validation staff and management. Engineer is expected to keep management and teammates informed as needed.

• Review document changes for validation and deviation impact and recommend corrective actions to validation manager and appropriate departments. Works to implement the required changes needed for corrective action.

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.

EXPERIENCE

• 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.

• Validation experience with the following is highly preferred: Thermal characterization, Vacuum physics, Heat and mass transfer, Formulation, Aseptic Filling and Lyophilization. Steam Sterilization

• Experience in multiple regulatory inspections and knowledgeable in current industry standards and regulatory trends as they pertain to Validation of pharmaceutical or biopharmaceutical processes.

COMMUNICATIONS & CONTACTS

• Interacts with all department staff to resolve technical issues and initiate process improvements.

• Must be able to work with multiple departments including Operations, Engineering, Facilities, Quality Control and Quality Assurance.

MANAGERIAL & SUPERVISORY RESPONSIBILITIES: None

TRAVEL: Approximately 15%

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.

PHYSICAL REQUIREMENTS & MENTAL DEMANDS

• 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

• Ability to multitask with competing demands and at times shifting priorities.

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

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.

EDUCATION

Bachelor's degree in engineering or related scientific discipline required with a minimum of four (4) plus years of pharmaceutical industry experience or combination of work experience in Validation, QA, MFG, or Engineering.

QUALITIES

• Organized individual who is experienced working in a result oriented-focused, dynamic CMO environment.

• Professional and collaborative team player with good interpersonal skills.

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

• Possess strong initiative to meet work goals with some guidance.

PROFESSIONAL SKILLS

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

• Possess good fundamentals of commissioning, qualification validation, practices, including applicable regulations.

• Has strong technical writing, verbal communication, and presentation skills.

• Proficient in Microsoft Office including Word, Excel, Power Point, Project

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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.