Manufacturing Engineer

VBeyond Corporation; Fall River (MA); On-site; USD 70,000 - 90,000; Full time

Benefits offered by this job

Medical insurance

Vision insurance

401(k)

Job summary

A pharmaceutical company in Fall River, MA is seeking a Manufacturing Validation Engineer to oversee the creation and revision of GMP documentation. The role requires effective cross-functional collaboration to ensure compliance and operational success, alongside responsibilities such as developing metrics and implementing continuous improvements. Candidates should have relevant experience in validation and familiarity with SOPs. This is a full-time position with options for professional growth.

Qualifications

• Ability to prepare qualification and validation documents.
• Experience writing, revising and creating cGMP records and SOPs.
• Knowledge in handling deviation, CAPA, change control.

Responsibilities

• Develop metrics and work with personnel to achieve targets.
• Create training materials and track periodic reviews.
• Lead root cause investigations and develop solutions.

Skills

Excellent communication skills

Drive and sense of urgency

Excellent computer skills

Solid organizational and time management skills

Ability to work as a self-starter

Knowledge of pharmaceutical manufacturing

Education

Associate’s degree with 4-6 years knowledge of GMP documentation

Bachelor’s degree in science, biochemistry, pharmaceutical engineering

Master’s degree in Pharmaceutical Engineering or related field

Tools

Microsoft Office Suite

SAP business system

Job description

Job Title: Manufacturing Validation Engineer

FLSA Classification: Professional, Exempt

Work Location: Fall River, MA

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

Reports To: Manufacturing Manager

Job Description

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.

The job duties for this position include but are not limited to the following:

• Develop appropriate disposition metrics, works with manufacturing/packaging personnel to achieve said targets. Generates and reports on metrics on an agreed frequency
• Creates training materials for subject matter input.
• Track and manage periodic review.
• 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.
• Develop, implement and assess solutions for complex problems. 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.
• Performs other duties as assigned.
• Knowledge of qualification and validation documents.
• Preparation of qualification and validation documents of equipment and computer system.
• Preparation and qualification of e-batch record & e-Log Book.
• Knowledge of cleaning validation and process validation.
• 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.

Education and Experience

• Associate’s degree with 4-6 years knowledge and experience of GMP documentation required.
• 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 communication skills, drive, and sense of urgency
• 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.
• Must have ability to work as a self-starter and handle multiple priorities in a dynamic cross-functional team-based environment.
• Knowledge of pharmaceutical manufacturing and related documents.
• Knowledge and experience writing, revising and creating cGMP records and SOPs.
• Knowledge of GDP.
• Creation and maintenance of batch record and cGMP documentation templates.
• Hands‑on experience facilitating problem solving and root cause investigations in a pharmaceutical environment - Develops, implements, and assesses solutions for complex problems.
• Ability to work effectively both independently and as part of a team.
• 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.
• Experience in Inhalation products (MDI) 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.
• During audit part of team.
• Knowledge of audits and compliance.

Professional and Behavioral Competencies

• Proficiently speak English as a first or second language
• Ability to understand and analyze complex data sets.
• Knowledge of statistical packages is a plus.
• Knowledge of good manufacturing practices and good documentation practices preferred.
• Ability to read, write and communicate effectively.
• Self‑motivated, with the ability to work in a fast‑paced manufacturing environment and handle multiple tasks simultaneously.
• Position requires flexibility to quickly adapt to changing work environment and schedules
• Excellent organizational skills with the ability to focus on details.
• Basic computer skills (Word and Excel) – Intermediate
• Good basic math knowledge and excellent attention to details.

Work Schedule and Other Position Information

• 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.

Seniority level

Mid‑Senior level

Employment type

Full‑time

Job function

Production, Manufacturing, and Other

Industries

Pharmaceutical Manufacturing, Biotechnology Research, and Medical Equipment Manufacturing

Benefits

Medical insurance, Vision insurance, 401(k)