Equipment Validation Engineers

Job Description

Our client – a growing company needs 2 Validation Engineers for permanent, (not consultants) roles at their plant in NJ. Excellent salary + Relocation Bonus + Full Benefits Pkg. Client will NOT sponsor or transfer any visas for OPT, H1-BJob Posting # 2685

Job Title: Equipment Validation Engineers

Qty = 2 for Level I + II (see note 3)

Compensation: Salary of $70K - $110K (based on level I or II per note 3)

Location: Toms River, NJ

Relocation: YES - Client offers relo assistance as sign on bonus of $5K - $10K

Benefits: Full package for medical, dental insurance, 401K, Tuition reimbursement, 11 Holidays + PTO.

Our client is a growing company with HQ + CDMO manufacturing at same site for sterile and specialty pharma products with around 450 people.

Group Info:

This Quality group has around 55 people from QC, QA, Compliance, including Validation. The validation department has around 19 people for validation of computer, metrology, equipment, Process, Cleaning, facility/Utility under the Director of Validation. This role will report to Validation Group Lead

Note 1: Candidates must be Permanent Residents or Citizens. This is a permanent role only so contractors will not be considered. Client will NOT sponsor or transfer any visas for OPT, H1-B, GC.

Note 2: This role is for Validating Equipment & Utilities systems. The equipment and systems can be for any type of drug manufacturing like oral Solids, Ointments, liquids and related Utility systems as mentioned in Job summary below. The client has mostly sterile liquid Manufacturing, filling & packaging and related Utility systems.

Note 3: The Client has 2 positions - 1 each. Level I with 1- 2 years & level II with 3+ years of experience

Note 4: The right person with extensive relevant experience will be considered even without a degree.

Job Summary:

The Validation Engineer is responsible for duties associated with qualifying manufacturing and packaging equipment and pharmaceutical utilities, including: HVAC Systems for Clean Classified Areas, USP Purified Water, USP Water-for-Injection, Clean Compressed Air, and nitrogen consistent with cGMP requirements for clinical manufacturing, scale-up and commercial manufacture of sterile and specialty pharmaceutical products.

Job functions include: generation of qualification / validation documents, execution of qualification / validation documents, generation of reports, managing project timelines, and participating in cross functional teams.

Candidate Must Have:

Bachelor’s degree in Engineering or related field.

1 – 4 years of Hands-on Validation experience in GMP clinical or commercial manufacturing

Good people, communication skills to work in a team environment

Ability to produce and present clear, concise, and professionally written communications.

Candidate Nice to Have:

Validation of Temp. Mapping system for warehouse and refrigerated areas

Creation of IQ, OQ, PQ validation protocols and final reports.

Knowledge of Sterile Aseptic Filling, packaging and related Utility systems.

Small company experience working in a dynamic fast paced environment.

Contract Manufacturing experience working closely with customers and clients

Keyword: BioPharma, Pharma, Quality, Validation Equipment, Sterile Aseptic filling, IQ, OQ, PQ, Protocols, Utilities WFI, US Water, HVAC, Clean rooms, Temp. Mapping

Full-time