Engineering - Equipment Commissioning & Qualification (ECQ) Engineer

Engineering - Equipment Commissioning & Qualification (ECQ) Engineer
100% onsite
Work Schedule: Mon-Fri(normal business hours)
Duration: 6 months(Possibility of extension for the right candidate depending on performance)


Position Summary:
The Engineer, Equipment Commissioning & Qualification (ECQ) Delivery supports
the successful implementation of equipment/instruments, facilities, and utilities, at
multi-use sites through interaction with internal customers and external service
providers.
The person in this role is responsible for commissioning, qualifying and/or
maintaining equipment/instruments, facilities, and utilities, in a commissioned
/qualified/validated state according to established policies and procedures. With
minimum supervision and given general instructions, this individual carries out
routine tasks and functions and uses basic analytical skills to recognize and solve
common problems of limited scope. This role will require management of outside
resources, and their own workload.
As a developing team player, the person in this role interacts with their immediate
supervisor and personnel within their own work group to achieve team goals while
building trust and collaborative relationships outside the immediate organization.

Duties/Responsibilities :
Commissioning and Qualification Activities:
" Maintain commissioned/qualified equipment, facilities, and utilities in
compliance with policies, guidelines, and procedures:
" Develop commissioning/qualification protocols, and associated reports while
adhering to a change management process.
" Supervise vendors for qualification functions.
" Support development of equipment operational procedures.
" Support all equipment validation activities. Execute equipment qualifications
and validation protocols.
" Develop validation/qualification deliverables such as Validation Plans,
Requirements Specifications, Design Specifications, Traceability Matrices, and
Summary Reports.
" Support Change Management process.
Project Work Support:
" Manage projects of limited scope and complexity within their functional area:
" Support equipment implementation projects including scheduling, site prep,
installation, qualification, and turn over to business area.
" Support internal customer groups in the operation, calibration, and preventive
maintenance of equipment to meet business needs in accordance with
required schedules or dates.

" Complete all qualification and validation documentation with accuracy,
completeness, and compliance to Client standards.
Customer Service and Support:
" Regularly review, prioritize, and promptly respond to customer equipment
qualification and support requests.
" Provide technical support and guidance on equipment qualification issues.
Interfaces with customers to ensure all expectations are being met.
" Provide technical support and guidance on equipment, utilities, facilities, and
computerized systems qualification and validations issues.
" Maintain a positive relationship with all team members and site customers
while promoting a positive team environment.
Regulatory Responsibilities:
" Ensure equipment, facilities and programs are maintained in compliance.
" May participate in deviation investigations as an SME.
Reporting Relationship Manager or Senior Manager

Qualifications
Specific Knowledge, Skills, Abilities:
" Knowledge of cGMP, GXP, GAMP, SDLC regulations, including 21CFR part
11, computer systems validation requirements and good documentation
practices.
" Knowledge of pharmaceutical, manufacturing and laboratory systems.
" Understanding of investigations, deviations and CAPA management in a
regulated pharmaceutical industry.
" Strong written and verbal communication skills.
" Excellent interpersonal skills with experience dealing with a diverse workforce.
" Strong multi tasking ability in conjunction with proven organizational skills.
" Ability to organize assigned tasks in a high paced environment and
concurrently monitor tasks / assignments with others that may impact timely
completion.
" Detail-oriented with strong commitment to quality, safety, and compliance.
" Ability to effectively manage multiple projects simultaneously and prioritize
tasks effectively.
" Highly proficient computer skills in Microsoft Office Suite Word, Excel,
PowerPoint, and Outlook with extensive background in database systems.
Innate ability to learn new software, such as corporate intranet and enterprise
business tools.
" Experience with Electronic Data Management Systems such as Valgenesis
preferred.

Education and Experience:
" BS in Engineering or Science related discipline preferred but can be
substituted with sufficient relevant experience.
" Minimum of 5 years of experience performing/supporting activities in a GMP
environment.
" Minimum of 3 years of experience in equipment, facilities, or utilities
qualification.

EEO:

Mindlance is an Equal Opportunity Employer and does not discriminate in employment on the basis of Minority/Gender/Disability/Religion/LGBTQI/Age/Veterans.