Validation Engineer MedPharma Manufacturing - 3.7 Fairfield, NJ Job Details Full-time $100,000 - $110,000 a year 1 day ago Benefits Commuter assistance Health savings account Disability insurance Health insurance Dental insurance 401(k) Flexible spending account Tuition reimbursement Paid time off Smoking cessation program Parental leave Employee assistance program Vision insurance 401(k) matching Professional development assistance Life insurance Retirement plan Pet insurance Qualifications Mechanical blueprint interpretation Customer communication Microsoft Excel Content creation for technical audiences Inspection tools Blueprint specification interpretation Interpersonal skills Technical documentation Statistical Process Control Technical writing experience within manufacturing

GMP GD&T

Minitab Production validation processes Quality standards in production Biomedical regulatory compliance FMEA Productivity software Quality audits PPAP Manufacturing company experience

Full Job Description Responsibilities:

Responsible for Master Validation Reports, including writing and execution of

IQ, OQ, PQ

Protocols Works independently, taking lead on PPAP / Validation Completion. Leads team to provide deliverables, and takes initiative to proactively management the PPAP Process, including all applicable APQP documentation. Responsible for SOP and Technical Writing for New Programs Must have practical knowledge of GMP, ISO13485, and/or 21 CFR 820 Compliance Represent the customer in order to ensure that the customer's quality expectations are clearly understood and being met. Support Program Management team on launch and management of medical device programs. Advanced Product Quality Planning (APQP) including completion of related documentation, including but not limited to: DOE's, FMEA's, Process Flowcharts, Control Plans, Capability Studies and Gage R&R's. Ability to participate in product design (R D) meetings with Medical Customers in relationship with understanding key quality deliverables. Oversee the development and input of initial BOM and detailed Routing Oversee the initiation and/or coordination of the change control process (ECO) relating to Engineering documentation. Primary auditee responsible for Validation, PPAP, APQP Packages to third party auditors. Ability to Understand Statistics as related to

SPC, GR&R, MSA

Studies Lead-in customer, internal and registrar quality system audits. Requirements Minimum of 5 yrs. (equivalent) experience in product quality position, with direct experience PPAP/Validation Deliverables. Experience in medical device/life science (GxP) industry required. Requires a 4-yr engineering degree or substitute experience; graduate degree in engineering, technical or management discipline is preferred. Ability to read blueprints and other technical documents. Understanding of

ANSI/ISO

drawing standards and GD&T dimensioning required. Ability to uses Minitab preferred. Knowledge of quality inspection tools and methods required. Familiarity with Statistical Process Control (SPC) tools and methods also preferable. Knowledge of

GMP/ISO/21 CFR 820

Quality Systems required. Knowledge of TQM, Six Sigma or Lean Manufacturing principles preferable. Knowledge of progressive metal stamping and/or insert molding processes desirable. Strong technical writing skills. Proficient in Microsoft Word, Excel, and PowerPoint. Knowledge or MRP or ERP software preferable. Excellent verbal and written communication skills. This position is at our Fairfield, NJ location.

Other Benefits Include:

Fully Paid Medical Medical, Dental and Vision 401 (k) with company match Holiday, Vacation and Sick Time Tuition Reimbursement Health Savings Accounts (HAS) Flexible Spending Accounts (FSA) Cigna Wellness Incentive Program Employee Assistance Program (EAP) Short Term Disability Group Life and Accidental Insurance Sun Life - Accident, Critical Illness, and Hospital Indemnity Insurance Smoking Cessation Program Pet Insurance Equal Opportunity Employer/Veterans/Disabled Benefit offerings include medical, dental, vision, term life insurance, short-term disability insurance, additional voluntary benefits, commuter benefits and 401K plan. Our program provides employees the flexibility to choose the type of coverage that meets their individual needs. Available paid leave may include Paid Sick Leave, where required by law; any other paid leave required by Federal, State or local law; and Holiday pay upon meeting eligibility criteria.

Disclaimer:

These benefit offerings do not apply to client-recruited jobs and jobs which are direct hire to a client To read our Candidate Privacy Information Statement, which explains how we will use your information, please visit https://www.entegee.com/candidate-privacy-information-statement/ The Company will consider qualified applicants with arrest and conviction records. #GRP2

Pay:

$100,000.00 - $110,000.00 per year

Benefits:

401(k) 401(k) matching Dental insurance Employee assistance program Health insurance Life insurance Paid time off Parental leave Professional development assistance Retirement plan Tuition reimbursement Vision insurance

Work Location:

In person