Director,
Process Engineering
A pharmaceutical company located in Connecticut is seeking
a Director, Process Engineering. The incumbent will
have the following responsibilities:
- The Process Engineer group will drive the integration
and start-up of new pharmaceutical equipment and processes
following technology transfer from Technology Development
to assure smooth implementation within commercial manufacturing
to meet business needs of the corporation.
- Lead process design engineering activities for strategic
capital projects. Project duties include developing
a preliminary engineering file through focused front
end loading with Technology Development, Commercial
Manufacturing and Quality Assurance.
- Developing specifications, design reviews of vendor
and engineering firm designs, Factory Acceptance testing
and commissioning.
- The candidate will lead product and component introductions,
identify and implement batch and yield improvements
and identify and implement process and safety improvements.
- He/she will drive FMEA to improve the quality and
reliability of design and will be the technical lead
for Quality Investigations and atypical events, as well
as resulting corrective or preventive action implementation.
The candidate will manage root cause analysis facilitation/participation
and will develop user requirements, detailed design
and equipment specifications.
- The candidate will train manufacturing units, as well
as generate and sustain controlled documentation (i.e.
support manuals, process flow diagrams, SOPs, P&IDs
and specifications) throughout equipment life cycle.
- He/she will conduct vendor audits and lead FAT efforts
at vendor sites and will identify, evaluate and implement
new process technologies in alignment with business
objectives or regulatory requirement.
- The candidate will manage periodic and change driven
evaluation of equipment preventive maintenance scope
and frequency and will troubleshoot critical process
or equipment issues escalated by front line responders.
- Engineer will develop cost estimates and schedules.
- Manage process-engineering group.
- Responsible for development and recruitment of engineering
staff, ensuring performance of staff, quality of engineering
service and application of engineering technology.
- Individual will mentor young engineers and provide
engineering expertise
to solve problems with existing production processes.
Requirements:
- 15+ years experience in applied process design engineering
activities including managing an engineering staff.
- Position requires a Bachelor's degree in chemical
engineering, a Master's degree in chemical engineering
is preferred
- Must have positive attitude
- Strong ability to work with others and become integrated
within the various teams
- Experience with start-up operations
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Senior
EHS Engineer
Well known pharmaceutical company in the Northern New
Jersey area is expanding their Environmental, Health
and Safety department and seeks a Senior Engineer to
assist the Director with the management and enhancement
of the EHS programs.
Summary Support the EHS group with technical skills
to ensure compliance with monitoring, record keeping,
and training requirements for OSHA, EPA and DOT regulations.
Essential Duties and Responsibilities
Compliance documentation, including environmental,
safety, health, industrial hygiene, and related areas.
Waste identification, management, disposal, documentation,
profile.
Prepare and deliver training on various EHS topics.
Conduct industrial hygiene monitoring on as needed
basis.
Ensure compliance with OSHA regulatory requirements.
Assist and support Site Safety Teams, First Aid Team,
and Spill Response Team.
Assist in safety audits.
Assist in benchmarking against federal, state, local
and industry best practices.
Assist with project management as needed.
Organize, manage and maintain OSHA reports, EPA and
State permits, Right to Know, MSDS, HAZMAT, Emergency
Response, coordinate with state, federal, local and
related agencies.
Assess, qualify, prioritize, communicate, organize,
address and manage priorities based on risk and exposure.
Requirements: Bachelors degree in environmental or
related. 3-5+ years of pharmaceutical industry experience.
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