We have other current jobs related to this field that you can find below
-
Sr. RF Validation Engineer
2 months ago
Andover, United States Skyworks Full timeIf you are looking for a challenging and exciting career in the world of technology, then look no further. Skyworks is an innovator of high performance analog semiconductors whose solutions are powering the wireless networking revolution. At Skyworks, you will find a fast-paced environment with a strong focus on global collaboration, minimal layers...
-
Lab Instrument Services Lead
2 months ago
Andover, Massachusetts, United States Pfizer Full timeRole SummaryPrimary purpose of Lab Instrument Services (LIS) Lead role is to oversee and implement the LIS program for Pfizer Research & Development (PRD) customers at the Andover, MA site. This includes the planning/scheduling of preventative and corrective maintenance of PRD lab instrumentation and management of those instruments through their life cycle....
-
Sr Staff Engineer, Verification and Validation
1 month ago
Andover, United States TFB Hospitality Full time```html What you'll be doing: The Root Cause Engineer is responsible for leading electrical issue identification and resolution for all electrical features on a program line to ensure successful vehicle support while working with various Engineering Support teams that include systems, wiring, design release and validation engineers, Program Management, and...
-
Sr. Radar Test and Validation Engineer
1 week ago
Andover, United States Raytheon Technologies Corporation Full timeDate Posted:2024-07-01 Country:United States of America. Location:MA 101: Andover MA 350 Lowell St Essex 350 Lowell Street Essex, Andover, MA, 01810 USA - Position Role Type:Onsite. At Raytheon, the foundation of everything we do is rooted in our v Validation Engineer, Validation, Engineer, Test Engineer, Production, Manufacturing, Systems
-
Technical Support Specialist V
5 days ago
Andover, Massachusetts, United States Experis Full timePosition: TechnicianLocation: OnsiteContract Duration: 24 MonthsCompensation: $18.00 to $21.00/hr.Overview: We are seeking a Technical Support Specialist V - Tier 2 to contribute to a leading Fortune 500 organization.Key Responsibilities:1. Analyze and interpret technical schematics, printouts, and specifications to perform evaluations.2. Assess the...
-
Sr. Business Analyst
2 weeks ago
Andover, United States Compunnel Inc. Full timeJob Title:- Sr. Business Analyst - Process ImprovementDuration:- 12+ Months ContractLocation:- Hybrid (2 Onsite at Andover, MA)Job Description:-As part of our continuous efforts to enhance organizational profitability and operational efficiency, we are seeking a seasoned Business Process Improvement Specialist to join our team on a temporary consulting...
-
Sr. Business Analyst
2 weeks ago
Andover, United States Compunnel Inc. Full timeJob Title:- Sr. Business Analyst - Process ImprovementDuration:- 12+ Months ContractLocation:- Hybrid (2 Onsite at Andover, MA)Job Description:-As part of our continuous efforts to enhance organizational profitability and operational efficiency, we are seeking a seasoned Business Process Improvement Specialist to join our team on a temporary consulting...
-
Clinical Support Specialist
6 days ago
Andover, Massachusetts, United States Integrated Dermatology of Brookline Full timePosition Overview:We are looking for a dedicated Clinical Support Specialist to become a vital part of our thriving Dermatology practice.Key Responsibilities:As a Clinical Support Specialist, you will be responsible for a variety of administrative and clinical tasks, including:Utilizing our Electronic Medical Record (EMR) system effectively.Assisting...
-
Sr. Reliability Engineer
2 weeks ago
Andover, United States Raytheon Full timeDate Posted:2024-08-15Country:United States of AmericaLocation:MA600: Andover, MA 366 Lowell St 366 Lowell Street , Andover, MA, USAPosition Role Type:OnsiteAt Raytheon , the foundation of everything we do is rooted in our values and a higher calling - to help our nation and allies defend freedoms and deter aggression. We bring the strength of more than 100...
-
Sr. Reliability Engineer
2 weeks ago
Andover, United States Raytheon Full timeDate Posted:2024-08-15Country:United States of AmericaLocation:MA600: Andover, MA 366 Lowell St 366 Lowell Street , Andover, MA, USAPosition Role Type:OnsiteAt Raytheon , the foundation of everything we do is rooted in our values and a higher calling - to help our nation and allies defend freedoms and deter aggression. We bring the strength of more than 100...
-
Sr. Reliability Engineer
2 weeks ago
Andover, United States Raytheon Full timeDate Posted: 2024-08-15 Country: United States of America Location: MA600: Andover, MA 366 Lowell St 366 Lowell Street , Andover, MA, 01810-5423 USA Position Role Type: Onsite At Raytheon, the foundation of everything we do is rooted in our values and a higher calling – to help our nation and allies defend freedoms and deter aggression. We bring the...
-
Andover, Massachusetts, United States WORK Inc Full timeJob Title: Community Training SpecialistCompany: WORK Inc.WORK Inc., a prominent organization dedicated to providing services for individuals with disabilities in New England, is seeking passionate individuals to join our team as Community Training Specialists. In this role, you will be instrumental in empowering individuals to achieve independence and lead...
-
Sr. Test Development and Validation Engineer
1 month ago
Andover, United States Raytheon Full timeDate Posted:2024-07-25Country:United States of AmericaLocation:MA101: Andover MA 350 Lowell St Essex 350 Lowell Street Essex, Andover, MA, 01810 USAPosition Role Type:OnsiteAt Raytheon, the foundation of everything we do is rooted in our values and a higher calling - to help our nation and allies defend freedoms and deter aggression. We bring the strength of...
-
Sr. CCM Test and Validation Engineer
1 month ago
Andover, United States Raytheon Technologies Full timeDate Posted: 2024-07-23 Country: United States of America Location: MA101: Andover MA 350 Lowell St Essex 350 Lowell Street Essex, Andover, MA, 01810 USA Position Role Type: Onsite At Raytheon, the foundation of everything we do is rooted in our values and a higher calling - to help our nation and allies defend freedoms and deter aggression. We bring the...
-
Sr. Test Development and Validation Engineer
2 weeks ago
Andover, United States Raytheon Full timeDate Posted:2024-07-25Country:United States of AmericaLocation:MA101: Andover MA 350 Lowell St Essex 350 Lowell Street Essex, Andover, MA, 01810 USAPosition Role Type:OnsiteAt Raytheon, the foundation of everything we do is rooted in our values and a higher calling - to help our nation and allies defend freedoms and deter aggression. We bring the strength of...
-
Sr. Test Development and Validation Engineer
1 month ago
Andover, United States Raytheon Full timeDate Posted: 2024-07-25 Country: United States of America Location: MA101: Andover MA 350 Lowell St Essex 350 Lowell Street Essex, Andover, MA, 01810 USA Position Role Type: Onsite At Raytheon, the foundation of everything we do is rooted in our values and a higher calling – to help our nation and allies defend freedoms and deter aggression. We bring the...
-
Sr. Test Development and Validation Engineer
4 weeks ago
Andover, United States Raytheon Full timeDate Posted:2024-07-25Country:United States of AmericaLocation:MA101: Andover MA 350 Lowell St Essex 350 Lowell Street Essex, Andover, MA, 01810 USAPosition Role Type:OnsiteAt Raytheon, the foundation of everything we do is rooted in our values and a higher calling - to help our nation and allies defend freedoms and deter aggression. We bring the strength of...
-
Sr. CCM Test and Validation Engineer
3 weeks ago
Andover, United States Raytheon Full timeDate Posted:2024-07-23Country:United States of AmericaLocation:MA101: Andover MA 350 Lowell St Essex 350 Lowell Street Essex, Andover, MA, 01810 USAPosition Role Type:OnsiteAt Raytheon, the foundation of everything we do is rooted in our values and a higher calling - to help our nation and allies defend freedoms and deter aggression. We bring the strength of...
-
Sr. CCM Test and Validation Engineer
2 months ago
Andover, United States Raytheon Full timeDate Posted: 2024-07-23 Country: United States of America Location: MA101: Andover MA 350 Lowell St Essex 350 Lowell Street Essex, Andover, MA, 01810 USA Position Role Type: Onsite At Raytheon, the foundation of everything we do is rooted in our values and a higher calling – to help our nation and allies defend freedoms and deter aggression. We bring the...
-
Sr. CCM Test and Validation Engineer
2 months ago
Andover, United States Raytheon Full timeDate Posted: 2024-07-23 Country: United States of America Location: MA101: Andover MA 350 Lowell St Essex 350 Lowell Street Essex, Andover, MA, 01810 USA Position Role Type: Onsite At Raytheon, the foundation of everything we do is rooted in our values and a higher calling – to help our nation and allies defend freedoms and deter aggression. We bring the...
Sr Instrument Validation Specialist
2 months ago
tendersglobal.net
Why Patients Need You
Pfizer is seeking a highly motivated and experienced candidate to support GMP activities for the validation group at the Andover site. This candidate is responsible for writing procedures, Requirement Specifications, investigations/deviations, commitments and change controls. This position requires working collaboratively with the QC raw materials, QC Analytical, QC Microbiology, Quality Assurance and Manufacturing groups.
In addition to validation, this candidate will manage change control action items and ensure on time closure of change controls. This candidate will actively participate in scheduling, visual management metrics, and continuous improvement activities. The successful candidate will be team oriented, have a passion for excellence, act with integrity, demonstrate equity and inclusivity, seek continuous improvement opportunities, actively participate in site recognition programs, and take pride in his or her contribution to the team.
What You Will Achieve
This position will provide support for the Instrument and associated software Validation Program at Pfizer Andover site.
The Senior Instrument Validation Specialist is expected to utilize their own subject matter expertise (SME), as well as collaborate with other site validation SMEs, to complete validation activities in compliance with corporate, regulatory, and industry standards and regulations.
The incumbent in this position will ensure Instrument validation activities are performed and maintained in a safe and cGMP compliant work environment and comply with company policies and regulatory/industry standards.
The incumbent will be expected to partner with the SME’s of the site Quality Assurance Validation group to ensure all validation strategies and validation executions meet all applicable Pfizer quality and compliance standards, local SOP’s, as well as applicable regulatory standards.
How You Will Achieve It
- The Senior Instrument Validation Specialist is expected to utilize their own subject matter expertise (SME), as well as collaborate with other site validation SMEs, to define, standardize and support the instrument validation programs and procedures in compliance with corporate, regulatory, and industry standards and regulations.
- This position will provide support for the validation program and validation projects at the Pfizer Andover site.
- Authors, reviews and approves routine to highly complex instrument validation deliverables [Validation Plan, Validation Strategy, Requirements Specification, Qualification Protocols (IQ,OQ, PQ), Change Control Implementation Plans and Impact/Risk Assessment, deviations, investigations, corrective actions and/or preventive actions for adequacy, logic and quality/validation/regulatory impact], for appropriateness, completeness and alignment with quality, validation and regulatory expectation, providing sounds quality and compliance judgment to ensure meeting Pfizer Quality Standards, 21CFRpart11, ICH, MHRA, WHO guidance.
- Provide technical support and fully implement change controls and commitments.
- Execute test protocols associated with change controls and commitments.
- Support internal and external audits.
- Apply technical and quality concepts, applicable guidelines of the FDA or other regulatory bodies and relevant SOPs.
- Plan and prioritize projects and track completion rates for projects.
- Demonstrated leadership skills in decision making, planning and prioritization. Focused on team success to meet defined metrics and timelines.
- Proficiency with computer systems (Trackwise, Veeva Vault, PDOCS, LIMS, etc.).
- Strong oral and written communication skills
- Candidate must be self-motivated and be able to adapt to rapidly changing project priorities and prioritize projects appropriately.
- Experience also required: background in problem solving, negotiations, and project management/support in a matrixed reporting environment. Candidate must be willing to work with vendors, QC, Manufacturing, Validation teams and have excellent customer service skills.
- Knowledge and experience in cGMP USP/EP/JP, regulatory guidance and audits
- Experience with DMAIC, lean, and continuous improvement tools desired
- Exercises judgment in resolving moderate to high impact/complex instrument/equipment issues.
- Incumbent knows and applies technical and quality concepts, applicable guidelines of the FDA or other regulatory bodies and relevant SOPs.
Qualifications
Must-Have
- Applicant must have a High School Diploma (or Equivalent) and 8 years of relevant experience OR an associate’s degree with 6 years of experience OR a bachelor’s with at least 3 years of experience OR Masters with more than 1 year of experience.
- Strong understanding of instrument and software validation experience required.
- Ample knowledge of GMP and regulatory requirements and data integrity principles.
- Effective writing and oral communication skills.
PHYSICAL/MENTAL REQUIREMENTS
Normal sitting, standing and walking requirements to facilities and in a laboratory environment.
NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
Position is first shift Monday through Friday. Some off hour support may be required to support staff and operations.
Work Location Assignment:On Premise
OTHER JOB DETAILS
- Last Date to Apply for Job: October 30, 2023
- Referral Bonus Eligibility: YES
- Eligible for Relocation Package: NO
The annual base salary for this position ranges from $78,000.00 to $126,300.00. In addition, this position is eligible for participation in Pfizer’s Global Performance Plan with a bonus target of 10.0% of the base salary. We offer comprehensive and generous benefits and programs to help our colleagues lead healthy lives and to support each of life’s moments. Benefits offered include a 401(k) plan with Pfizer Matching Contributions and an additional Pfizer Retirement Savings Contribution, paid vacation, holiday and personal days, paid caregiver/parental and medical leave, and health benefits to include medical, prescription drug, dental and vision coverage. Learn more at Pfizer Candidate Site – U.S. Benefits tendersglobal.net (uscandidates.mypfizerbenefits.com). Pfizer compensation structures and benefit packages are aligned based on the location of hire. The United States salary range provided does not apply to Tampa, FL or any location outside of the United States.
Relocation assistance may be available based on business needs and/or eligibility.
Sunshine Act
Pfizer reports payments and other transfers of value to health care providers as required by federal and state transparency laws and implementing regulations. These laws and regulations require Pfizer to provide government agencies with information such as a health care provider’s name, address and the type of payments or other value received, generally for public disclosure. Subject to further legal review and statutory or regulatory clarification, which Pfizer intends to pursue, reimbursement of recruiting expenses for licensed physicians may constitute a reportable transfer of value under the federal transparency law commonly known as the Sunshine Act. Therefore, if you are a licensed physician who incurs recruiting expenses as a result of interviewing with Pfizer that we pay or reimburse, your name, address and the amount of payments made currently will be reported to the government. If you have questions regarding this matter, please do not hesitate to contact your Talent Acquisition representative.
EEO & Employment Eligibility
Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Pfizer is an E-Verify employer.
Engineering
#LI-PFE
To help us track our recruitment effort, please indicate in your cover/motivation letter where (tendersglobal.net) you saw this job posting.
