Process Engineer

This role will design, develop,

optimize, and support GMP drug product manufacturing and packaging

process, including equipment, facilities, and control systems at

our Middletown, Delaware site. This may include support of CQV

programs for manufacturing / packaging equipment, instruments,

utilities, and processes. The Engineer is also responsible for

ensuring external and internal quality standards are applied and

followed.

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Implementing and maintaining

manufacturing process automation and control

systems.

Participate

as a member of cross functional teams in completion of system

impact evaluations and system risk assessments in a multi-product

facility. Performs gap assessments and remediates new risks as new

equipment and / or products are

introduced.

Assists

with the preparation and maintenance of User Requirements

Specifications.

Ensuring

compliance with regulatory requirements (FDA, EMA, cGMP), quality

standards, and safety

regulations.

Conducting

risk assessments and supporting equipment / utilities qualification

activities.

Hands-on

experience with troubleshooting and resolving process

equipment-related issues during

production.

Experience

managing equipment, Preventive Maintenance, Calibration, and

reliability programs independently with minimum

supervision.

Experience

with OSD equipment but not limited to Wet Granulation systems, Bin

Blenders, Encapsulation, Tablet Presses, Tablet Coaters, Roller

Compactors, etc. is a

must.

Experience in

packaging equipment like bottle packaging, blister packaging, and

powder

packaging.

Collaborating

with cross-functional teams, including R&D, Quality Assurance,

Production, and Regulatory

Affairs.

Experience in

writing Change Controls, Investigation reports, Work Orders, CAPA,

Standard Operating Procedures (SOP), and risk

assessments.

Analyzing

process data and driving continuous improvement initiatives to

enhance efficiency, reduce costs, and improve product

quality.

Providing

technical support and training to production staff on new

processes, equipment, and safety

protocols.

Identifies

and proposes process improvement ideas and collaborates with

cross-functional teams to meet project deliverables and timelines,

including scheduling, testing, and deviation

resolution.

Performs

other related duties as

assigned.

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3 - 5 years of experience in a

Process or Equipment engineering role, preferably in the

pharmaceutical drug products manufacturing

industry.

Ability to

read and understand engineering drawings such as P&IDs,

equipment / facility layout drawings, electrical / pneumatic drawings,

and functional

specifications.

Thorough

understanding of cGMP and FDA

requirements

Strong

communication and documentation

skills

Proven project

management

skills

Experience with

equipment qualification following ISPE and ASTM

guidelines.

Proficient

with Microsoft Office Suite, Maximo, Calibration program software,

MES, etc.

Preferred

Qualifications : Prior

experience as an equipment or process engineer with process control

systems and troubleshooting of pharmaceutical manufacturing

processes and packaging

equipment.

Familiarity

with Sterile F / F equipment qualification is a

plus.

Familiarity with

the IOQ / PQ process / packaging equipment for the pharmaceutical

industry.

Familiarity

with Maximo or equivalent Regulatory Asset Manager

software.

Experience

Education : Bachelor’s

degree in engineering (Mechanical, Electrical, Industrial) or a

related field.

3-5

years of maintenance experience in a pharmaceutical, biotechnology,

life science, or FDA-regulated manufacturing

environment.

Knowledge

/ Skills /

Abilities : Technical :

Strong understanding of engineering principles, process design and

optimization, quality control, pharmaceutical manufacturing

technologies, equipment, and relevant software. Knowledge of cGMP

guidelines and regulatory compliance is

essential.

Analytical

& Problem-Solving : Ability to analyze complex processes and

data, identify bottlenecks, troubleshoot issues, and develop

effective

solutions.

Soft

Skills : Excellent communication (written and verbal), teamwork,

leadership, project management, organizational abilities, time

management, adaptability, attention to detail, critical thinking,

and negotiation skills.

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Industry Specific : Familiarity with FDA

regulations, cGMP guidelines, Lean Manufacturing, and risk

assessment techniques (HAZOP,

FMEA).

An

Equal Opportunity Employer. All qualified applicants will receive

consideration for employment without regard to race, color,

religion, sex, sexual orientation, gender identity, national

origin, or protected veteran status and will not be discriminated

against on the basis of

disability

This

job description does not state or imply that the above are the only

duties and responsibilities assigned to this position. Employees

holding this position will be required to perform any other

job-related duties as requested by

Management.