Validation Engineer IV
Company: PCI Pharma Services
Location: Bedford
Posted on: April 2, 2026
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Job Description:
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 –
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. LI-AK2
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.
Keywords: PCI Pharma Services, Arlington , Validation Engineer IV, Engineering , Bedford, Massachusetts
