Project Manager, Technical Support

Production Support Rochester, Michigan


Description

Description: cid:A1548F0C-58F6-4866-A7F9-03CA2587CEB3

Job Description

 

Job Title

Technical Support Project Manager

Company

Par Pharmaceutical

Function

Operations and Manufacturing

Location(s)

Rochester, MI

Department

Validation

Direct Reports (list)

N/A

Reports to (title)

Manager, Validation Technology

Date Submitted

9/23/2016

To be completed by Corporate Compensation:

Job Code

J03810

Band

C

Date Reviewed

9/23/2016

Benchmark

T434-3B

EEO

2

FLSA  (USA only)

Exempt

 

Job Summary - a concise overview of the job

 

The Technical Support Project Manager, in partnership with site leaders, sponsors a quality and compliance focused site culture which embraces RFT (Right First Time) and CI (Continuous Improvement) expectations.  Support all aspects of the Validation Life Cycle in Manufacturing from design through operation and improvement as required.  Creates new validation approaches for legacy and new products / processes or to align procedures and standards.  Further responsible for supporting protocol rationales/justifications for the chosen validation methodology/approach.

 

Maintain up to date knowledge of validation requirements, practices, and procedures and instruct other members of the site participating in validation studies.  Participate on cross-functional teams to address specific problems, facilitate discussion and research, and enable procedures to become more efficient.

 

Promote a positive working environment, as well as collaborate with peer group and Par management to satisfy strategic departmental goals and objectives.  Proactive leader who is accountable to provide expert technical opinion to management to assist in formulation and execution of department strategic planning to ensure the department is positioned to meet or exceed industry and regulatory expectations. Ensure projects are carried out with a consistent approach and on a timely basis in line with the strategy as well as applicable regulatory requirements.

 

All incumbents are responsible for following applicable Division & Company policies and procedures.

Scope of Authority - span of control (work unit, site, department, division, etc.), monetary value of budget/spend authority (capital, operating, etc.), P&L responsibility, etc.

 

 

Key Accountabilities - key outcomes/deliverables, the major responsibilities, and % of time

Accountability

Responsibilities

% of Time

Validation Projects

  • Ability to manage multiple validation projects with varying degrees of complexity.
  • Provide technical expertise to cross functional teams for validation of products, cleaning and processes within aseptic operations.
  • Write validation master plans, protocols, and reports. Participate in validation execution, review and compile resultant data, write and compile validation reports and maintain re-validation oversight.
  • Create, review, and track validation and monitoring plan schedules for process and cleaning
  • Apply scientific principles, theories, and risk management concepts in conducting daily validation responsibilities
  • Conduct research into generally accepted industry standards, FDA regulations and guidance and international standard organizations
  • Act as a key member of teams which determine most effective validation approaches, strategies, and acceptance criterion

40%

Continuous Improvement

  • Identification, initiation, support and follow up of projects for continuous improvement of manufacturing processes (i.e. Legacy Process and Continued Process Verification initiatives) with target to improve efficacy at the manufacturing site

15%

Project Management

  • Provide project management and/or technical oversight, planning, coordination and support to the site for projects related to process-related changes, technical transfers, regulatory changes, life cycle management, technical trouble shooting, and overarching changes to products or materials
  • Ability to manage multiple validation projects with varying degrees of complexity
  • Identification, initiation, support and follow up of projects for continuous improvement of manufacturing processes (i.e. Cleaning Validation initiatives) with target to improve efficacy at the manufacturing site
  • Coordinate site and departmental initiatives in support of projects that result in increased performance or regulatory compliance of manufacturing and quality operations.
  • Apply scientific principles, theories, and risk management concepts in conducting daily validation responsibilities.
  • Must display personal accountability for results and integrity.

30%

Quality Projects

  • Coordinate site and departmental initiatives in support of projects that result in cost/schedule savings, increased performance or regulatory compliance of manufacturing and quality operations.
  • Support or lead investigation teams established to solve major quality issues occurring with the manufacturing processes.

15%

Cross Functional

  • Provide technical expertise to cross functional teams in regards to validation of cleaning processes, products and processes associated to aseptic operations
  • Support or lead investigation teams established to solve major quality issues occurring with the manufacturing processes
  • Interact in a team environment with other individuals representing Manufacturing, Engineering, Quality Assurance, Process Development, Regulatory Affairs, and Project Management
  • Act as a key member of teams which determine most effective validation approaches, strategies, and acceptance criterion
  • Team player, results oriented, with focus on quality and deliverables

Continuous

Production Process

Qualification

  • Responsible for the performance qualification of production processes, and writes process validation protocols and final report packages
  • Generates, executes and summaries Product Process Qualification for the entire scope of the production processes
  • Comprehensive understanding of all production processing steps and through knowledge of required validations

Continuous

Cleaning

  • Create, review, and track validation and monitoring plan schedules for Process and Cleaning
  • Must be able to work in controlled or clean room environments requiring special gowning. Will be required to follow gowning requirements and wear protective clothing over the head, face, hands, feet and body. No make-up, jewelry, contact lenses, nail polish or artificial fingernails may be worn in these work environments

Continuous

Deviation Investigation

  • Conducts deviation investigations
  • Evaluates equipment or process problems and designs testing to determine possible causes or solutions.

Continuous

Standard Operating Procedures

  • Conduct research into generally accepted industry standards, FDA regulations and guidance and international standard organizations

Continuous

Total

100%

 

Qualifications

Education & Experience

Minimal acceptable level of education, work experience and certifications required for the job

  • Bachelor of Science/Bachelor of Arts (Chemistry, Engineering, Life Sciences, and Pharmacy) or other discipline related to the work area
  • Minimum of 8 years of relevant work experience in cGMP/FDA regulated industry
  • Minimum of 5 years hands on experience (or applicable combination) with cleaning validation

Knowledge

Proficiency in a body of information required for the job   

e.g. knowledge of FDA regulations, GMP/GLP/GCP, Lean Manufacturing, Six-Sigma, etc.

  • Solid knowledge of Project Management tools
  • Must have demonstrated experience in 3 of the following: Process Validation, Cleaning Validation, Equipment Validation, Sterilization Validation, Validation of Aseptic Processing
  • Strong understanding of FDA regulations 21 CFR, Parts 210 & 211 (cGMP), Part 820 (Quality System Regulation)
  • Strong understanding of ICH guidelines (ICH Q7 – ICH Q10)
  • Experience presenting/defending validation work during FDA or similar regulatory agencies inspections / audits
  • Practical knowledge on the various risk assessment tools (FMEA, HAZOP, etc.)
  • Strong in authoring/executing validation strategies, risk assessments, validation protocols, and technical completion reports
  • In-depth understanding of statistic-analysis including the application of statistical models to validation, design of experiments and statistical evaluation of data derived from execution of validations
  • Expert knowledge of cGMPs, FDA/CFRs relevant to CGMP manufacturing and validation
  • Proficient in Microsoft Word, Excel, Power Point, Project and other software relevant to the performance of the Job
  • Microsoft Visio and Projects
  • Trackwise or equivalent

Skills

&

Abilities

Often referred to as “competencies”, leadership attributes, skills, abilities or behaviors that may be enterprise, functional or job specific      e.g. coaching, negotiation, calibration, technical writing etc.

  • Problem Solving - Identifies and resolves problems in a timely manner; Gathers and analyzes information skillfully; Develops alternative solutions; Works well in group problem solving situations; Uses reason even when dealing with emotional topics.
  • Project Management - Develops project plans; Coordinates projects; Communicates changes and progress; Completes projects on time and budget; Manages project team activities.
  • Technical Skills - Assesses own strengths and weaknesses; Pursues training and development opportunities; Strives to continuously build knowledge and skills; Shares expertise with others.
  • Customer Service - Manages difficult or emotional customer situations; Responds promptly to customer needs; Solicits customer feedback to improve service; Responds to requests for service and assistance; Meets commitments.
  • Interpersonal Skills - Focuses on solving conflict, not blaming; Maintains confidentiality; Listens to others without interrupting; Keeps emotions under control; Remains open to others' ideas and tries new things.
  • Oral Communication - Speaks clearly and persuasively in positive or negative situations; listens and gets clarification; Responds well to questions; Demonstrates group presentation skills; Participates in meetings.
  • Written Communication - Writes clearly and informatively; Edits work for spelling and grammar; Varies writing style to meet needs; Presents numerical data effectively; Able to read and interpret written information.
  • Teamwork - Balances team and individual responsibilities; Exhibits objectivity and openness to others' views; Gives and welcomes feedback; Contributes to building a positive team spirit; Puts success of team above own interests; Able to build morale and group commitments to goals and objectives; Supports everyone's efforts to succeed.
  • Visionary Leadership - Displays passion and optimism; Inspires respect and trust; mobilizes others to fulfill the vision; Provides vision and inspiration to peers and subordinates.
  • Leadership - Exhibits confidence in self and others; Inspires and motivates others to perform well; effectively influences actions and opinions of others; Accepts feedback from others; Gives appropriate recognition to others.
  • Quality Management - Looks for ways to improve and promote quality; Demonstrates accuracy and thoroughness.
  • Diversity - Demonstrates knowledge of EEO policy; Shows respect and sensitivity for cultural differences; educates others on the value of diversity; promotes a harassment-free environment; Builds a diverse workforce.
  • Ethics - Treats people with respect; Keeps commitments; inspires the trust of others; Works with integrity and ethically; Upholds organizational values.
  • Organizational Support - Follows policies and procedures; Completes administrative tasks correctly and on time; supports organization's goals and values; Benefits organization through outside activities; Supports affirmative action and respects diversity.
  • Strategic Thinking - Develops strategies to achieve organizational goals; Understands organization's strengths & weaknesses; Analyzes market and competition; Identifies external threats and opportunities; Adapts strategy to changing conditions.
  • Judgment - Displays willingness to make decisions; Exhibits sound and accurate judgment; Supports and explains reasoning for decisions; Includes appropriate people in decision-making process; Makes timely decisions.
  • Motivation - Sets and achieves challenging goals; Demonstrates persistence and overcomes obstacles; Measures self against standard of excellence; Takes calculated risks to accomplish goals.
  • Planning/Organizing - Prioritizes and plans work activities; Uses time efficiently; Plans for additional resources; Sets goals and objectives; Organizes or schedules other people and their tasks; Develops realistic action plans.
  • Professionalism - Approaches others in a tactful manner; Reacts well under pressure; Treats others with respect and consideration regardless of their status or position; Accepts responsibility for own actions; Follows through on commitments.
  • Quality - Demonstrates accuracy and thoroughness; Looks for ways to improve and promote quality; Applies feedback to improve performance; Monitors own work to ensure quality.
  • Quantity - Meets productivity standards; Completes work in timely manner; Strives to increase productivity; Works quickly.
  • Safety and Security - Observes safety and security procedures; Determines appropriate action beyond guidelines; Reports potentially unsafe conditions; Uses equipment and materials properly.
  • Adaptability - Adapts to changes in the work environment; Manages competing demands; Changes approach or method to best fit the situation; Able to deal with frequent change, delays, or unexpected events.
  • Attendance/Punctuality - Is consistently at work and on time; Ensures work responsibilities are covered when absent; Arrives at meetings and appointments on time.
  • Dependability - Follows instructions, responds to management direction; Takes responsibility for own actions; Keeps commitments; Commits to long hours of work when necessary to reach goals. Completes tasks on time or notifies appropriate person with an alternate plan.
  • Initiative - Volunteers readily; Undertakes self-development activities; Seeks increased responsibilities; Takes independent actions and calculated risks; Looks for and takes advantage of opportunities; Asks for and offers help when needed.
  • Innovation - Displays original thinking and creativity; Meets challenges with resourcefulness; Generates suggestions for improving work; Develops innovative approaches and ideas; Presents ideas and information in a manner that gets others' attention.

Physical Requirements

Physical & mental requirements     e.g. lift 40 pounds, walk across plant/warehouse, business travel (% of time), driving as part of work responsibilities, etc.

  • Wet or Humid
  • Work near moving mechanical parts
  • Fumes or airborne particles
  • Working in a aseptic environment/gowning
  • Stand
  • Walk
  • Sit
  • Lift
  • Talk or hear
  • Must be able to work in controlled or clean room environments requiring special gowning. Follow gowning requirements and wear protective clothing overhead, face, hands, feet and body. No make-up, jewelry, contact lenses, nail polish or artificial fingernails may be worn in these work environments.

 

Disclaimer:  The above statements are intended to describe the general nature and level of work performed by employees assigned to this job. They are not intended to be an exhaustive list of all duties, responsibilities, and qualifications.  Management reserves the right to change or modify such duties as required.

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Customer Focus Results DrivenLeadership Teamwork Innovation and Continuous Improvement

 

Endo Job Description Template - Revised July 2014