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Bedford, Massachusetts, United States
Onsite
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.
Summary of Objective:
The Validation Engineer IV performs an array of well-defined validation activities in support of cGMP pharmaceutical/medical device contract manufacturing across multiple facilities. In collaboration with validation management, the engineer provides guidance to internal project teams and external validation firms on large/complex validation/qualification initiatives and 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:
Author validation plans; oversee and provide direction in 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 Protocols.
Review and approve commissioning, qualification and validation related system lifecycle documentation (user requirements, functional and design specifications, commissioning and qualification protocols).
Provide direction on equipment/process change control development (equipment, utilities, facilities, and processes) used to develop and manufacture products in a cGMP environment.
Work closely 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.
Perform a periodic review of systems to monitor the validation status of the system as well as write and develop validation SOPs.
Help define validation strategies based on regulations, guidance documents, industry practice and experience.
Assist management with mentoring and training of colleagues on policies and procedures including the requirements for validation.
Team representative on validation projects leading by example on significant projects requiring complex technical solutions.
Develop and recommend science-based solutions with a focus on continuous improvement and compliance.
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.
Work in a highly independent fashion, with minimal to no direction in the execution of duties, while keeping team mates and manager informed and providing guidance to other engineers as needed.
Write protocols and technical study approaches.
Review document changes for validation impact.
Review deviation reports for validation impact.
Review and approval of change controls.
Propose corrective actions to validation manager and appropriate departments and implement the required changes.
Professional Skills:
Knowledge of Industry guidelines (ISPE, PDA), US and international regulations (FDA, ICH, ISO, EMA) for validation of GMP facilities.
Possess strong knowledge of commissioning, qualification validation and related practices, including applicable regulations.
Excellent technical writing, verbal communication and presentation skills.
Technical understanding of pharmaceutical/biotechnology unit operations.
Ability to evaluate compliance issues.
Strong skills in team development and leadership.
Successful demonstration of collaboration with validation management, and project teams.
Proficiency in Microsoft Office including Word, Excel, Power Point, Project
Qualities:
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.
Ability to inspire others to strive for excellence.
Self-motivated and able to meet goals with minimal supervision.
TRAVEL – <15%
Qualifications:
Bachelor’s degree in Engineering or related scientific discipline required with a minimum of eight (8) years of Pharmaceutical industry experience or combination of work experience in Validation, Quality, Production, or Engineering.
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.
Direct Validation experience with pharmaceutical or biopharmaceutical processes including the development of strategies, master plans, protocols and reports.
Validation experience with the following is highly preferred: Thermal characterization, Vacuum physics, Heat and mass transfer, Formulation, Aseptic Filling and Lyophilization. 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.
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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.
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.
