validation engineer Hauppauge, NY
Premier Care Industries
Full Time
Hauppauge, NY
93282 - 66410 USD ANNUAL Today
Job description
Exciting opportunity for a Validation Engineer in a fast-growing, disposable consumer products company, located on Long Island, NY.
The successful candidate will have a thorough, working knowledge of equipment qualifications (IQ, OQ), as well as manufacturing validations (PV), in a cGMP FDA-regulated industry. The candidate will also possess excellent mechanical abilities, working with various equipment and instruments, in a manufacturing environment.
The candidate chosen for the Validation Engineer position will also possess excellent people skills, be a team player, be able to take initiative when necessary and carry out all responsibilities in accordance with company policies, core values and applicable laws.
JOB FUNCTIONS:
- Will draft Validation Protocols (IQ, OQ, PQ, PV) and execute them in a timely manner.
- Will obtain an in-depth knowledge of PCI’s existing manufacturing processes and equipment, in order to identify any validation gaps, as well as any improvement opportunities.
- Will review/examine current equipment usage, preventative maintenance, efficiency and product quality, in order to implement any operational or equipment improvements, as needed.
- Will collaborate with PCI’s R&D team on new product introductions, on the design & sourcing of any custom equipment or the modification of existing equipment, as needed.
- Will assist with the creation of Risk Assessments, such as FMEA or FMECA.
QUALIFICATIONS / EDUCATION REQUIREMENTS
- Bachelor’s Degree in Engineering preferred
- Minimum 5 years prior validation experience in a cGMP regulated industry, preferably as a Validation Engineer
- Ability to draft Validation Protocols (IQ, OQ, PQ, PV) and execute them
- Knowledge of basic quality tools, risk analysis & statistics
- Demonstrated good written and oral communication skills
- Preferably bilingual (English and Spanish knowledge, both verbal and written)
- Proficiency in Microsoft Office package
Employment Type Full-Time; Permanent
Job Functions Manufacturing, Quality Assurance
Education College Degree in Engineering
Experience minimum 5 years
Manages Others None
Industry cGMP FDA-regulated
Location Hauppauge, NY
Required Travel None
Job Functions Manufacturing, Quality Assurance
Education College Degree in Engineering
Experience minimum 5 years
Manages Others None
Industry cGMP FDA-regulated
Location Hauppauge, NY
Required Travel None
BENEFITS:
Comprehensive Benefits Package, including 401(k)
We are an equal opportunity employer. Women, minorities, veterans and individuals with disabilities are encouraged to apply.
Comprehensive Benefits Package, including 401(k)
We are an equal opportunity employer. Women, minorities, veterans and individuals with disabilities are encouraged to apply.
Job Type: Full-time
Premier Care Industries
www.precare.com
Hauppauge, NY
Unknown / Non-Applicable
Unknown
Company - Public
