Process Engineer & OpEx Lead
Company: Piramal Enterprises Ltd.
Posted on: June 10, 2021
POSITION SUMMARY: Piramal Pharma Solutions' HPAPI Research and
Manufacturing facility, located in Riverview, Michigan (Ash
Stevens, LLC, hereafter referred to as PPS-Riverview), is seeking a
qualified Process Engineer & Operational Excellence (OpEx) Lead to
join our Technology Transfer team.
To perform this position successfully, an individual must be
able to perform each essential duty satisfactorily. The
requirements listed below are representative of the knowledge,
skill and/or ability required:
- Shall adhere to all applicable regulatory requirements,
including FDA, EPA, OSHA, and related safety, health and
environmental procedures, policies and practices.
- Consistent support and practice of all Piramal Pharma Solutions
mission, vision, and values.
- Identify and protect the original technical information as part
of the company property.
- Responsible for the continual improvement for the site. Drive
ideation every year to optimize cost, productivity, and Manage
Projects throughout the plant in all the departments.
- Conduct Kaizen and KPI competition amongst team, sharing OE
best practices across various plants in the organization.
- Lead focused improvement teams & daily management teams and
show improvements in chosen KPIs.
- Be the subject matter expert in the use of Lean and Six Sigma
tools & methodology; ensure that the tools are used appropriately
by team members. Identify, and assist in the removal of barriers to
- Report project status and financial results, ensuring 2-way
open communication throughout the functions/ organization for
- Responsible for conceptualizing and managing various
cross-functional business initiatives in project mode with the use
of analytical techniques.
- Responsible for working with Technology Transfer and the Client
to generate, revise, and approve master production records (MPRs)
and any other documents associated with the commercial products in
the manufacturing, e.g. SOPs, material specifications, technical
- Preparing unplanned and planned deviations for responsible
processes and forming the investigation team.
- Collaborates with PD, Technology Transfer, Ops, Quality Control
(QC), and Quality Assurance (QA) in problem solving activities,
including deviation writing and CAPA closure.
- Work with project and engineering teams to replace, modify, or
buy equipment for continuous improvement and/or capacity
- Responsible for training GMP Manufacturing personnel on the new
- Functions as the technical interface between Piramal Riverview
and the Client, focusing on providing technical advice and support,
engineering solutions, oversee GMP runs in the plant equipment, and
analyzing of production data for evaluation of process performance
and writing production summaries.
- Requires solid understanding of the manufacturing processes,
GMP guidelines, site and corporate policies and procedures,
hands-on experience, and full understanding of production processes
in the GMP environment as laid out at site.
- Willingness to work flexible hours and shifts when there is a
- Responsible for providing independent production support during
- Ability to travel as needed.
- Generate URS (user requirement specification/Design basis) for
capital requests and/or equipment/facility modifications.
- Participate in site PHA and HAZAOP studies for facilities and
- Ensure process data is being updated on a monthly basis;
analyze manufacturing KPI performance for improvement and
discussion with client. Coordinate the qualification of primary and
secondary regulatory starting material suppliers for assigned
- Take part in the Operational Excellence activities in the
- Internal: Technology Transfer; Process Development; Quality
Assurance; Quality Control; Supply Chain; Facilities & Maintenance;
Warehouse; EHS; Operation Excellence
- External: Clients; Engineering companies and vendors
COMPLIANCE WITH POLICIES AND REGULATIONS:
- Compliance with 21 CFR - Parts 210/211, EU Directives
91/356/EEC and ICH Q7.
- Compliance with SOPs, batch records, forms, logs of use and
- Recognize common sources of failure and improve documentation
to reduce deviations and errors.
- Work with Operations personnel to improve compliance.
- Ensure work is in compliance with all state and federal
regulations, including but not limited to OSHA, GMP, DEA, FDA,
- Assist in the formulation of corrective procedures when
- Use appropriate PPE while inside a manufacturing area.
- Assume responsibility for safety and knowing the appropriate
emergency procedures in case of emergency.
- Know the location of SDS binders and understand how the
guidelines pertain to employees.
The physical demands and work environment described here are
representative of those that must be met by a team member to
successfully perform the essential functions of this job.
Reasonable accommodations may be made to enable individuals with
disabilities to perform the essential functions. If any
accommodations are needed, requests should be made to our Human
equal employment opportunity.
Piramal Pharma Solutions is proud to be an Equal Employment
Opportunity and Affirmative Action employer. We do not discriminate
based upon race, religion, color, national origin, gender
(including pregnancy, childbirth, or related medical conditions),
sexual orientation, gender identity, gender expression, age, status
as a protected veteran, status as an individual with a disability,
or other applicable legally protected characteristics.
Keywords: Piramal Enterprises Ltd., Fargo , Process Engineer & OpEx Lead, Other , Michigan, North Dakota
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