Equipment Commissioning & Qualification (ECQ) Engineer (20-20848)
Company: Axelon Services Corporation
Location: Summit
Posted on: January 16, 2021
|
|
Job Description:
The Equipment Engineer, Equipment Commissioning & Qualification
Operations supports the successful operation of laboratory,
clinical and commercial manufacturing operations at their home site
through interaction with internal team members and internal
customers as well as external service providers. 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. As a
developing team player, the incumbent 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. The incumbent may
be asked to lead small to medium sized projects in their area of
responsibility and will be called upon to create and revise work
processes or procedures that impact their immediate function or
organizational unit. The incumbent will be involved with writing
deviations, investigations and supporting the implementation of
change controls.REQUIRED COMPETENCIES: Knowledge, Skills, and
Abilities:--- Knowledge of cGMP, GXP, GAMP, SDLC regulations,
including 21CFR part 11, computer systems validation requirements
and good documentation practices.--- Advanced knowledge of
pharmaceutical, manufacturing and laboratory systems and
equipment.--- Strong written and verbal communication skills.---
Excellent interpersonal skills with experience dealing with a
diverse workforce where individual initiative, accountability to
the team, and professional maturity are required.--- 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. Ability to effectively
manage multiple tasks and activities simultaneously.--- 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.--- Working knowledge of
scheduling software and systems, and inventory management systems,
mainly Blue Mountain RAM.--- Ability to interact effectively with
laboratory, QA and Facilities groups.Education and Experience:
------ BS in Engineering or Science related discipline
preferred.Minimum 2 years' experience in FDA-regulated industry---
Experience working directly with bench top manufacturing and
laboratory equipment (cell counters, liquid handlers, Flow
Cytometry, etc.) preferred.--- Knowledge of cGMP in the
pharmaceutical industry--- Excellent computer skills including
knowledge of calibration management and environmental monitoring
systems--- Strong problem-solving skills, strong verbal and written
communication skills, and the ability to work independently.---
Must have strong interpersonal and communication skills, be a team
player and be willing to work in an environment where individual
initiative, accountability to the team, and professional maturity
are required--- 2 years of maintenance coordinating / planning
experience, preferably in a laboratory environment.--- Experience
working in a commercial environment preferred.DUTIES AND
RESPONSIBILITIES:1) Operational Activitiesa. Executes equipment
calibration, preventative maintenance, performance verification and
repair activities in both laboratory and manufacturing areas.b.
Supervises vendors for calibration, preventative maintenance,
performance verification and repair functions.c. Reviews and
approves vendor executed calibration, maintenance, repair, and
performance verification records for accuracy, completeness and
compliance to Client standards.d. Works closely with and enters
data into the site CMMS system.e. Ensures all calibration, PM, and
performance verification records are filed appropriately after
approval.f. Writes and supports deviations and investigations that
result from calibration or performance verification failures along
with developing and supporting the implementation of corrective and
preventative actions.g. Support the development, revision and
review of written procedures for calibration, preventive
maintenance and performance verification of equipment.h. Support
the development, review and approval of calibration and maintenance
plans in site CMMS system.i. Supports the execution of equipment
performance verification and process improvement studies.j. Adheres
to all policies and procedures which govern the ECQ team and the
equipment theymanage in order to ensure compliance is held to the
highest standard.2) Promotes and provides excellent customer
service and supporta. Regularly reviews, prioritizes and promptly
responds to customer equipment performance verification and support
requests.b. Provides technical support and guidance on calibration,
equipment performance verification and validations issues.
Interfaces with customers to ensure all expectations are being
met.c. Maintains a positive relationship with all the members of
the Equipment Commissioning &Qualification department and site
customers while promoting a positive team environment.3) Inventory
Managementa. Work with planning group to ensure system is updated
as calibration, maintenance and performance verification activities
are performed.4) Regulatory Responsibilitiesa. Maintains all
required Corporate, Facilities and EHS training as required.b.
Adheres to all safety procedures and hazard communication.c. May be
called upon to act as SME in both internal and regulatory
audits.Additional Job Requirements:NoneJob Requirements:EQUIPMENT,
CGMP, GXP, PART11, VALIDATE, CFRPART. SDL2017
Keywords: Axelon Services Corporation, New York , Equipment Commissioning & Qualification (ECQ) Engineer (20-20848), Other , Summit, New York
Click
here to apply!
|
Didn't find what you're looking for? Search again!
Other Other JobsRN Nurse Educator Description: DESCRIPTIONNurse EducatorLuxor Nursing and Rehabilitation at Mills Pond is looking to hire a Registered Nurse Educator for our Skilled Nursing Facility in St. James, NY. The ideal candidate will be able (more...) Company: Luxor Nursing and Rehabilitation at Mills Pond Location: Saint James Posted on: 01/17/2021 Case Manager (Bilingual) - CAC Suffolk Mutli-disciplinary Team Enhancement Initiative (MDTEI) Description: EAC Network seeks a Part Time Bilingual Case Manager for the Child Advocacy Center CAC Suffolk Mutli-disciplinary Team Enhancement Initiative MDTEI program located in Riverhead, NY. The position is (more...) Company: EAC Network Location: Coram Posted on: 01/17/2021 Caterpillar Machine Inside Sales Representative Description: Overview: H.O. Penn Machinery, the Caterpillar dealer for Metro New York and all of the state of Connecticut, is currently HIRING for an Inside Sales Rep for Caterpillar Machinery at their Holtsville, (more...) Company: H.O. Penn Machinery Company, Inc. Location: Holtsville Posted on: 01/17/2021 Primary Care NP Job Description: Primary Care NP Needed in Long Island, NY Day Shift A non-profit primary care center is seeking a passionate Primary Care Company: K.A. Recruiting, Inc. Location: Blue Point Posted on: 01/17/2021 CNA / Caregiver - Competitive Pay, Flexible Scheduling Description: Now hiring Certified Nursing Assistants CNAs and Caregivers alike for various immediate job openings to provide companionship and care services to the elderly in your area. Here's why CNAs and Caregivers (more...) Company: CareInHomes Location: West Sayville Posted on: 01/17/2021 Get New Handyman Work Today - Preview Leads In Your Area Description: Over 25 million homeowners have trusted HomeAdvisor 1800Contractor to help them find quality professionals with the expertise to turn their home improvement Company: HomeAdvisor Location: Westport Posted on: 01/17/2021 Psychiatric Nurse Practitioner (Nurse Practitioner #) Description: Outstanding opportunity for full-time board-certified Psychiatric Nurse Practitioner to join our outpatient practice in Shirley, Company: Northeast Healthcare Recruitment, Inc. Location: Shirley Posted on: 01/17/2021 Field Auto Damage Appraiser Description: At Liberty Mutual, our purpose is to help people embrace today and confidently pursue tomorrow. That's why we provide an environment focused on openness, inclusion, trust and respect. Here, you'll discover (more...) Company: Liberty Mutual Insurance Location: Hauppauge Posted on: 01/17/2021 Weekend Warriors needed in our Packaging Facility. 12 Hour Shifts 2 or 3 days per week Description: Company DescriptionThe Nature's Bounty Co. is a privately held, global leader in health and wellness with a rich history and proven track record in the nutritional market. As a manufacturer, marketer (more...) Company: The Nature's Bounty Co. Location: Holbrook Posted on: 01/17/2021 High Demand For Quality Contractors - Get New Clients In Your Area Description: Over 25 million homeowners have trusted HomeAdvisor 1800Contractor to help them find quality professionals with the expertise to turn their home improvement Company: HomeAdvisor Location: Westport Posted on: 01/17/2021 |