REMOTE Manufacturing Engineering

Manufacturing Validation Engineer

Work Hours: General Shift: 8:30AM - 5:00PM (may vary based on business needs)

Reports To: Manufacturing Manager

The Manufacturing Validation Engineer is responsible for the creation and revision of new and existing GMP, project handle, qualification & validation documents preparation and execution. In this role the Validation Engineer adheres to the company’s document and SOP’s procedures while ensuring their accuracy, quality, and integrity. This position reports to the Manufacturing/Packaging and partners with cross functional team members to ensure compliance and operational success through user focused documentation.

Develop appropriate disposition metrics, works with manufacturing/packaging personnel to achieve said targets. Creates training materials for subject matter input.

Develop strategies and documents for cleaning and process validation of API equipment and products in compliance with site SOPs and regulatory guidance.

Autonomously leads and manages projects to implement continuous improvement opportunities.

Lead and/or support root cause investigations related to performance trends and formal deviations.

Anticipates risk and builds contingencies to help mitigate impact.

Reviews documents for accuracy and completeness.

Defends the validation programs and strategies to customers and regulatory auditors.

Performs weekly quality reviews of Master Control database by assuring new documents have been entered using appropriate protocols.

Follows strict internal protocols and Standard Operating Procedures (SOPs) as well as following current Good Manufacturing Practices (cGMP), complying with legal regulations, monitoring environment.

Knowledge of qualification and validation documents.

Preparation of qualification and validation documents of equipment and computer system.

Knowledge in project handle with new equipment.

Knowledge of URS, FDS, DQ, HDS, SDS, FS, validation plan, FAT, SAT, IQ, OQ, PQ, validation certificate, PIR, RTM, electronic signature, electronic reports.

Knowledge of 21 CFR and implementation. Knowledge of automation of pharmaceutical equipment.

Bachelor’s degree in science, biochemistry, pharmaceutical engineering, Pharmaceutical Sciences, or related discipline from an accredited college/university (preferred).

Master’s degree in Pharmaceutical Engineering, Pharmaceutical Sciences, or related field of study from an accredited college/university preferred.

Minimum four (4) years documentation experience and six (6) years related pharmaceutical or biotech industry experience. Preference will be given to candidates with experience in generic pharmaceutical manufacturing.

Technical Knowledge and Computer Systems Skills

Excellent computer skills, specifically Microsoft Office Suite.

Solid organizational and time management skills are required to prioritize activities in a manner consistent with departmental and site wide objectives.

Follow strict internal protocols and Standard Operating Procedures (SOPs) as well as following current Good Manufacturing Practices (cGMP), complying with legal regulations, monitoring environment.

Knowledge of pharmaceutical manufacturing and related documents.

Knowledge and experience writing, revising and creating cGMP records and SOPs.

Hands‑on experience facilitating problem solving and root cause investigations in a pharmaceutical environment - Develops, implements, and assesses solutions for complex problems.

Capable of handling and participating in compliance and regulatory audits at the local and federal levels.

Experience using SAP business system and applications is a plus.

Knowledge and handling of deviation, CAPA, change control, FMECA and training.

Knowledge and handling of SAP system, master control and track wise system.

Proficiently speak English as a first or second language

Ability to understand and analyze complex data sets.

Knowledge of good manufacturing practices and good documentation practices preferred.

Self‑motivated, with the ability to work in a fast‑paced manufacturing environment and handle multiple tasks simultaneously.

Basic computer skills (Word and Excel) - Intermediate

Must be willing to work in a pharmaceutical manufacturing setting.

Must be willing to work some weekends based on business needs as required by management.

No remote work available.

Full‑time

Production, Manufacturing, and Other

Pharmaceutical Manufacturing, Biotechnology Research, and Medical Equipment Manufacturing

Medical insurance, Vision insurance, 401(k)

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